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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes (onset®8)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Faster-acting insulin aspart

insulin aspart

insulin degludec

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 greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Mealtime faster-acting insulin aspart and insulin degludec

Mealtime NovoRapid® and insulin degludec

Postmeal faster-acting insulin aspart and insulin degludec

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c 26 Weeks After Randomisation

Change from baseline (week 0) in HbA1c was evaluated after 26 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 Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)

The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). 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 26 Weeks After 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) 26 Weeks After 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 Targets (HbA1c < 7.0%) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation

The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.

Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. 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 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. 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 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. 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 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. 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 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. 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 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. 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 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements

The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).

Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L

Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia

Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia

The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.

Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)

Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).

Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)

The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation

A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation

A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall

ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia. NN Classification: Severe:same as per ADA classification Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.

Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.

Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.

Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)

The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.

Change From Baseline in Blood Pressure 26 Weeks After Randomisation

Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Pulse 26 Weeks After Randomisation

Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation

The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

Change From Baseline in Erythrocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Haematocrit 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Haemoglobin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Leukocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Thrombocytes 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Albumin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Total Bilirubin 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Potassium 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Creatinine 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Total Protein 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation

Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation

Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation

Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation

Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).

Change From Baseline in Body Weight 26 Weeks After 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 26 Weeks After Randomisation

The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Full Information

NCT ID

NCT02500706

First Posted

July 15, 2015

Last Updated

May 28, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02500706

Brief Title

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

Acronym

onset®8

Official Title

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 4, 2016 (Actual)

Primary Completion Date

July 17, 2017 (Actual)

Study Completion Date

August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

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

1108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mealtime faster-acting insulin aspart and insulin degludec

Arm Type

Experimental

Arm Title

Mealtime NovoRapid® and insulin degludec

Arm Type

Active Comparator

Arm Title

Postmeal faster-acting insulin aspart and insulin degludec

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Intervention Description

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Primary Outcome Measure Information:

Title

Change From Baseline in HbA1c 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Secondary Outcome Measure Information:

Title

Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation

Description

The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation

Description

The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Time Frame

Week 0, week 26

Title

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation

Description

The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

Time Frame

26 weeks after randomisation

Title

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation

Description

Time Frame

26 weeks after randomisation

Title

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation

Description

Time Frame

26 weeks after randomisation

Title

Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)

Description

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Time Frame

Week 0, week 26

Title

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)

Description

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Time Frame

Week 0, week 26

Title

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile

Description

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Time Frame

Week 0, week 26

Title

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements

Description

Time Frame

Week 0, week 26

Title

Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L

Description

Time Frame

26 weeks after randomisation

Title

Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia

Description

Time Frame

26 weeks after randomisation

Title

Description

Time Frame

26 weeks after randomisation

Title

Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)

Description

Time Frame

Week 0, week 26

Title

Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)

Description

Time Frame

Week 0, week 26

Title

Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation

Description

Time Frame

Week 0 to week 26 (+7 days)

Title

Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation

Description

Time Frame

Week 0 to week 26 (+7 days)

Title

Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall

Description

Time Frame

Week 0 to week 26 (+1 day)

Title

Description

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.

Time Frame

Week 0 to week 26 (+1 day)

Title

Description

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: Severe: same as per ADA classification Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.

Time Frame

Week 0 to week 26 (+1 day)

Title

Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Blood Pressure 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Pulse 26 Weeks After Randomisation

Description

Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Erythrocytes 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Haematocrit 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Haemoglobin 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Leukocytes 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Thrombocytes 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Albumin 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Total Bilirubin 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Potassium 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Creatinine 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Total Protein 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation

Description

Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation

Description

Time Frame

Week 0, week 26

Title

Change From Baseline in Body Weight 26 Weeks After Randomisation

Description

The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

Title

Change From Baseline in Body Mass Index 26 Weeks After Randomisation

Description

The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

Time Frame

Week 0, week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85714

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

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

Escondido

State/Province

California

ZIP/Postal Code

92025

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

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Monterey

State/Province

California

ZIP/Postal Code

93940

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

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

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

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

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

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

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

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

Flint

State/Province

Michigan

ZIP/Postal Code

48503-5904

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

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

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

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

Hamilton

State/Province

New Jersey

ZIP/Postal Code

08690

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lawrenceville

State/Province

New Jersey

ZIP/Postal Code

08648

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109-2134

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

Rochester

State/Province

New York

ZIP/Postal Code

14607

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

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bend

State/Province

Oregon

ZIP/Postal Code

97702

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

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

78731

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

Beaumont

State/Province

Texas

ZIP/Postal Code

77701

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75218

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

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

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

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

Spokane

State/Province

Washington

ZIP/Postal Code

99201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Dimitrovgrad

ZIP/Postal Code

6400

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2H 2G4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

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

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01219

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Lingen

ZIP/Postal Code

49808

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

Schweinfurt

ZIP/Postal Code

97421

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500072

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Visakhapatnam

State/Province

Andhra Pradesh

ZIP/Postal Code

530002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380006

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380052

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Rohtak

State/Province

Haryana

ZIP/Postal Code

124001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kozhikode

State/Province

Kerala

ZIP/Postal Code

673017

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452010

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bhubaneswar

State/Province

Orissa

ZIP/Postal Code

751019

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 013

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600086

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632004

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

ZIP/Postal Code

110029

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Delhi

ZIP/Postal Code

110001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

ZIP/Postal Code

411011

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

93106

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Rishon Le Zion

ZIP/Postal Code

75650

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Ancona

ZIP/Postal Code

60100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Sesto San Giovanni (MI)

ZIP/Postal Code

20099

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Amagasaki-shi, Hyogo

ZIP/Postal Code

661-0002

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-ku, Tokyo

ZIP/Postal Code

103-0002

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ebina-shi, Kanagawa

ZIP/Postal Code

243-0432

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukuoka

ZIP/Postal Code

830 8522

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukushima

ZIP/Postal Code

963-8851

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0062

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hokkaido

ZIP/Postal Code

062-0007

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki

ZIP/Postal Code

305-0812

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Izumisano-shi

ZIP/Postal Code

598 0048

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

235-0045

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kobe-shi, Hyogo

ZIP/Postal Code

657-0846

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Matsumoto-shi, Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Mito-shi, Ibaraki

ZIP/Postal Code

311-4153

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Miyazaki

ZIP/Postal Code

880-0034

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Oita-shi

ZIP/Postal Code

870 0039

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka-shi, Osaka

ZIP/Postal Code

545 8586

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

569-1045

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ota-ku, Tokyo

ZIP/Postal Code

1430015

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi, Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

162 8666

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420061

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630047

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

194358

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

195213

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

410053

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Citations:

PubMed Identifier

30949906

Citation

Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.

Results Reference

background

PubMed Identifier

30259644

Citation

Buse JB, Carlson AL, Komatsu M, Mosenzon O, Rose L, Liang B, Buchholtz K, Horio H, Kadowaki T. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes (onset®8)

Diabetes, Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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