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Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes (Onset® 5)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Faster-acting insulin aspart

insulin aspart

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, age at least 18 years at the time of signing the informed consent
Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

Exclusion Criteria:

Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faster-acting insulin aspart CSII

NovoRapid® CSII

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.

Secondary Outcome Measures

Change From Baseline in 1-hour PPG Increment

Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in 1,5-anhydroglucitol

Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM

Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.

Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes

Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.

Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)

Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.

Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)

Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.

Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile

Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.

Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)

Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile

Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements

Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.

Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia

Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.

Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)

Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Insulin Dose in Units/Day: Total Basal

Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.

Insulin Dose in Units/Day: Total Bolus

Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Dose in Units/Day: Total Daily Insulin Dose

Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Dose in Units/Day: Individual Meal Insulin Dose

No data was collected for individual meal insulin dose.

Insulin Dose in Units/kg/Day: Total Basal

Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Dose in Units/kg/Day: Total Bolus

Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Dose in Units/kg/Day: Total Daily Insulin Dose

Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose

No data was collected for individual meal insulin dose.

Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio

Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Delivery Pump Parameter: Glucose Sensitivity Factor

Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Insulin Delivery Pump Parameter: Active Insulin Time

Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Mean of the IG Profile

Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)

Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Variation in the IG Profile

Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]

Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in AUCIG,0-15min

Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in AUCIG,0-30min

Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in AUCIG,0-1h

Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in AUCIG,0-2h

Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in AUCIG,0-4h

Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in Time to the IG Peak After Start of Meal

Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in IG Peak After Start of Meal

Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Number of Treatment Emergent Adverse Events (AEs)

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.

Number of Treatment Emergent Infusion Site Reactions

Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall

ADA classification of hypo: Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. Asymptomatic: PG ≤3.9 mmol/L without symptoms. Probable symptomatic: No measurement with symptoms. Pseudo: PG >3.9 mmol/L with symptoms. Unclassifiable. NN classification of hypo: BG confirmed: PG <3.1 mmol/L with/without symptoms. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)

Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal

Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.

Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)

Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.

Change From Baseline in Physical Examination: Respiratory System

Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Cardiovascular System

Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Central and Peripheral Nervous System

Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth

Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Musculoskeletal System

Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Skin

Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck

Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Vital Sign: Blood Pressure

Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Vital Sign: Pulse

Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Screening in Electrocardiogram (ECG)

Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Screening in Fundus Photography/Fundoscopy

Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Haematology: Leucocytes

Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Total Protein

Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)

Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)

Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)

Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Biochemistry: Total Bilirubin

Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis: Albumin/Creatine Ratio

Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis: Erythrocytes

Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis: Protein

Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis: Ketones

Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Body Weight

Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Change From Baseline in Body Mass Index (BMI)

Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Number of Change-of-infusion-sets Per Week

Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets

Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. Reasons for change-of-infusion-sets are categorised as follows: Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing

Full Information

NCT ID

NCT02825251

First Posted

July 4, 2016

Last Updated

November 12, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02825251

Brief Title

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

Acronym

Onset® 5

Official Title

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 6, 2016 (Actual)

Primary Completion Date

June 20, 2017 (Actual)

Study Completion Date

July 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

472 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Faster-acting insulin aspart CSII

Arm Type

Experimental

Arm Title

NovoRapid® CSII

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Intervention Description

Injected s.c. /subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

Injected s.c. /subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

Change in Glycosylated Haemoglobin (HbA1c)

Description

Time Frame

Week 0, week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in 1-hour PPG Increment

Description

Time Frame

Week 0, Week 16

Title

Change From Baseline in 1,5-anhydroglucitol

Description

Time Frame

Week 0, Week 16

Title

Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Fasting Plasma Glucose (FPG)

Description

Time Frame

Week 0, week 16

Title

Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)

Description

Time Frame

Week 16

Title

Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes

Description

Time Frame

Week 16

Title

Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile

Description

Time Frame

Week 0, week 16

Title

Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile

Description

Time Frame

Week 0, week 16

Title

Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements

Description

Time Frame

Week 0, week 16

Title

Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]

Description

Time Frame

Week 16

Title

Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia

Description

Time Frame

Week 16

Title

Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)

Description

Time Frame

Week 0, week 16

Title

Insulin Dose in Units/Day: Total Basal

Description

Time Frame

Week 16

Title

Insulin Dose in Units/Day: Total Bolus

Description

Time Frame

Week 16

Title

Insulin Dose in Units/Day: Total Daily Insulin Dose

Description

Time Frame

Week 16

Title

Insulin Dose in Units/Day: Individual Meal Insulin Dose

Description

No data was collected for individual meal insulin dose.

Time Frame

Week 16

Title

Insulin Dose in Units/kg/Day: Total Basal

Description

Time Frame

Week 16

Title

Insulin Dose in Units/kg/Day: Total Bolus

Description

Time Frame

Week 16

Title

Insulin Dose in Units/kg/Day: Total Daily Insulin Dose

Description

Time Frame

Week 16

Title

Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose

Description

No data was collected for individual meal insulin dose.

Time Frame

Week 16

Title

Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio

Description

Time Frame

Week 16

Title

Insulin Delivery Pump Parameter: Glucose Sensitivity Factor

Description

Time Frame

Week 16

Title

Insulin Delivery Pump Parameter: Active Insulin Time

Description

Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Time Frame

Week 16

Title

Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)

Description

Time Frame

Week 0, week 16

Title

Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Description

Time Frame

Week 16

Title

Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])

Description

Time Frame

Week 16

Title

Change From Baseline in Mean of the IG Profile

Description

Time Frame

Week 0, week 16

Title

Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)

Description

Time Frame

Week 16

Title

Variation in the IG Profile

Description

Time Frame

Week 16

Title

Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]

Description

Time Frame

Week 16

Title

Change From Baseline in AUCIG,0-15min

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in AUCIG,0-30min

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in AUCIG,0-1h

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in AUCIG,0-2h

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in AUCIG,0-4h

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Time to the IG Peak After Start of Meal

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in IG Peak After Start of Meal

Description

Time Frame

Week 0, week 16

Title

Number of Treatment Emergent Adverse Events (AEs)

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Infusion Site Reactions

Description

Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal

Description

Time Frame

Weeks 0-16

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal

Description

Time Frame

Weeks 0-16

Title

Description

Time Frame

Weeks 0-16

Title

Description

Time Frame

Weeks 0-16

Title

Description

Time Frame

Weeks 0-16

Title

Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)

Description

Time Frame

Weeks 0-16

Title

Change From Baseline in Physical Examination: Respiratory System

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Cardiovascular System

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Central and Peripheral Nervous System

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Musculoskeletal System

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Skin

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Vital Sign: Blood Pressure

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Vital Sign: Pulse

Description

Time Frame

Week 0, week 16

Title

Change From Screening in Electrocardiogram (ECG)

Description

Time Frame

Week 0, week 16

Title

Change From Screening in Fundus Photography/Fundoscopy

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Haematology: Haemoglobin

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Haematology: Haematocrit

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Haematology: Erythrocytes

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Haematology: Thrombocytes

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Haematology: Leucocytes

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Total Protein

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Creatinine

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Sodium

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Potassium

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Albumin

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Biochemistry: Total Bilirubin

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Urinalysis: Albumin/Creatine Ratio

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Urinalysis: Erythrocytes

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Urinalysis: Protein

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Urinalysis: Ketones

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Body Weight

Description

Time Frame

Week 0, week 16

Title

Change From Baseline in Body Mass Index (BMI)

Description

Time Frame

Week 0, week 16

Title

Number of Change-of-infusion-sets Per Week

Description

Time Frame

Week 0-16

Title

Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets

Description

Time Frame

Week 0-16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age at least 18 years at the time of signing the informed consent Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.) HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial Exclusion Criteria: Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening Planned coronary, carotid or peripheral artery revascularisation known on the day of screening History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Ramon

State/Province

California

ZIP/Postal Code

94583

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30339

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404-7596

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005-4144

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224-2215

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404-1192

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78749

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75149

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlon

ZIP/Postal Code

6700

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2E1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4N 7L3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Concord

State/Province

Ontario

ZIP/Postal Code

L4K 4M2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6M 1M1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

Novo Nordisk Investigational Site

City

LA ROCHELLE cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Creusot

ZIP/Postal Code

71200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

MONTPELLIER cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Narbonne

ZIP/Postal Code

11108

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Saint Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Novo Nordisk Investigational Site

City

TOULOUSE cedex

ZIP/Postal Code

31054

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Friedrichsthal

ZIP/Postal Code

66299

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Rehlingen-Siersburg

ZIP/Postal Code

66780

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Apeldoorn

ZIP/Postal Code

7334 DZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Eindhoven

ZIP/Postal Code

5631 BM

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Hoogeveen

ZIP/Postal Code

7909 AA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Rotterdam

ZIP/Postal Code

3011 TA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Cheboksary

ZIP/Postal Code

428009

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199226

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410039

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yoshkar-Ola

ZIP/Postal Code

424004

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Ljubljana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Novo mesto

ZIP/Postal Code

8000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Harrogate, North Yorkshire

ZIP/Postal Code

HG2 7SX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Manchester

ZIP/Postal Code

M13 0JE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

St Helens

ZIP/Postal Code

WA9 3DA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28918652

Citation

Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.

Results Reference

result

PubMed Identifier

30537180

Citation

Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.

Results Reference

result

PubMed Identifier

34524005

Citation

Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

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Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes (Onset® 5)

Diabetes, Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial