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Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN 8)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Canagliflozin

Placebo (canagliflozin)

Placebo (semaglutide)

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: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide + canagliflozin placebo

Canagliflozin + semaglutide placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c

Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.

Secondary Outcome Measures

Change in Body Weight (kg)

Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Total Fat Mass (kg)

Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in FPG (Fasting Plasma Glucose)

Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile

Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in SMPG- Mean Postprandial Increment Over All Meals

Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Fasting Total Cholesterol

Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Fasting LDL-cholesterol

Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Fasting HDL-cholesterol

Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Fasting Triglycerides

Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)

Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Percentage Change in Body Weight (%)

Change in Body Mass Index (BMI)

Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Change in Waist Circumference

Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Percentage Change in Total Fat Mass (%)

Change in Total Lean Mass (kg)

Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Percentage Change in Total Lean Mass (%)

Change in Visceral Fat Mass (kg)

Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Percentage Change in Visceral Fat Mass (%)

Change in Ratio Between Total Fat Mass and Total Lean Mass

Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)

Percentage of participants who achieved HbA1c < 7.0% (53 millimoles per mole [mmol/mol]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved Weight Loss ≥3% (Yes/no)

Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved Weight Loss ≥5% (Yes/no)

Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved Weight Loss ≥10% (Yes/no)

Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)

Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.

Total Number of Treatment Emergent Adverse Events (TEAEs)

A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented.

Change in Haematological Parameter- Haemoglobin

Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Haematological Parameter- Haematocrit

Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Haematological Parameter- Erythrocytes

Change from baseline (week 0) to week 52 in erythrocytes (10^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Haematological Parameter- Leukocytes

Change from baseline (week 0) to week 52 in leukocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Haematological Parameter- Thrombocytes

Change from baseline (week 0) to week 52 in thrombocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Amylase

Change from baseline (week 0) to week 52 in amylase (units per liter [U/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Lipase

Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- ALT

Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- AST

Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- ALP

Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Total Bilirubin

Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Creatinine

Change from baseline (week 0) to week 52 in creatinine (micromoles per liter [umol/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- eGFR

Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters [mL/min/1.73m^2])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Albumin

Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Calcium

Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Potassium

Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Biochemistry Parameter- Sodium

Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Calcitonin

Change from baseline (week 0) to week 52 in calcitonin (nanograms per liter) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Pulse

Change from baseline (week 0) to week 52 in pulse is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in ECG

The electrocardiogram (ECG) was assessed by the investigator at baseline (week 0) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Physical Examination

Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 52 is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Eye Examination

Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.

Change in Short Form 36 Health Survey (SF-36): Sub-domains

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.

Change in SF-36: Physical Component Summary (PCS)

Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.

Change in SF-36: Mental Component Summary (MCS)

Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Control of Eating Questionnaire (CoEQ): Domains

The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.

Change in CoEQ: Individual Items

Full Information

NCT ID

NCT03136484

First Posted

March 14, 2017

Last Updated

January 8, 2020

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03136484

Brief Title

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

Acronym

SUSTAIN 8

Official Title

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

October 16, 2018 (Actual)

Study Completion Date

November 16, 2018 (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 Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

6. Conditions and Keywords

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

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

788 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide + canagliflozin placebo

Arm Type

Experimental

Arm Title

Canagliflozin + semaglutide placebo

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type

Drug

Intervention Name(s)

Canagliflozin

Intervention Description

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type

Drug

Intervention Name(s)

Placebo (canagliflozin)

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

Primary Outcome Measure Information:

Title

Change in HbA1c

Description

Time Frame

Week 0, week 52

Secondary Outcome Measure Information:

Title

Change in Body Weight (kg)

Description

Time Frame

Week 0, week 52

Title

Change in Total Fat Mass (kg)

Description

Time Frame

Week 0, week 52

Title

Change in FPG (Fasting Plasma Glucose)

Description

Time Frame

Week 0, week 52

Title

Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile

Description

Time Frame

Week 0, week 52

Title

Change in SMPG- Mean Postprandial Increment Over All Meals

Description

Time Frame

Week 0, week 52

Title

Change in Fasting Total Cholesterol

Description

Time Frame

Week 0, week 52

Title

Change in Fasting LDL-cholesterol

Description

Time Frame

Week 0, week 52

Title

Change in Fasting HDL-cholesterol

Description

Time Frame

Week 0, week 52

Title

Change in Fasting Triglycerides

Description

Time Frame

Week 0, week 52

Title

Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)

Description

Time Frame

Week 0, week 52

Title

Percentage Change in Body Weight (%)

Description

Time Frame

Week 0, week 52

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Week 0, week 52

Title

Change in Waist Circumference

Description

Time Frame

Week 0, week 52

Title

Percentage Change in Total Fat Mass (%)

Description

Time Frame

Week 0, week 52

Title

Change in Total Lean Mass (kg)

Description

Time Frame

Week 0, week 52

Title

Percentage Change in Total Lean Mass (%)

Description

Time Frame

Week 0, week 52

Title

Change in Visceral Fat Mass (kg)

Description

Time Frame

Week 0, week 52

Title

Percentage Change in Visceral Fat Mass (%)

Description

Time Frame

Week 0, week 52

Title

Change in Ratio Between Total Fat Mass and Total Lean Mass

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)

Description

Time Frame

Week 52

Title

Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Description

Time Frame

Week 52

Title

Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved Weight Loss ≥3% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved Weight Loss ≥5% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved Weight Loss ≥10% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)

Description

Time Frame

Week 0, week 52

Title

Total Number of Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Weeks 0-57

Title

Change in Haematological Parameter- Haemoglobin

Description

Time Frame

Week 0, week 52

Title

Change in Haematological Parameter- Haematocrit

Description

Time Frame

Week 0, week 52

Title

Change in Haematological Parameter- Erythrocytes

Description

Time Frame

Week 0, week 52

Title

Change in Haematological Parameter- Leukocytes

Description

Time Frame

Week 0, week 52

Title

Change in Haematological Parameter- Thrombocytes

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Amylase

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Lipase

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- ALT

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- AST

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- ALP

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Total Bilirubin

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Creatinine

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- eGFR

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Albumin

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Calcium

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Potassium

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry Parameter- Sodium

Description

Time Frame

Week 0, week 52

Title

Change in Calcitonin

Description

Time Frame

Week 0, week 52

Title

Change in Pulse

Description

Time Frame

Week 0, week 52

Title

Change in ECG

Description

Time Frame

Week 0, week 52

Title

Change in Physical Examination

Description

Time Frame

Week -2, week 52

Title

Eye Examination

Description

Time Frame

Week 0, week 52

Title

Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Weeks 0-57

Title

Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Weeks 0-57

Title

Change in Short Form 36 Health Survey (SF-36): Sub-domains

Description

Time Frame

Week 0, week 52

Title

Change in SF-36: Physical Component Summary (PCS)

Description

Time Frame

Week 0, week 52

Title

Change in SF-36: Mental Component Summary (MCS)

Description

Time Frame

Week 0, week 52

Title

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

Description

Time Frame

Week 0, week 52

Title

Change in Control of Eating Questionnaire (CoEQ): Domains

Description

Time Frame

Week 0, week 52

Title

Change in CoEQ: Individual Items

Description

Time Frame

Week 0, week 52

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

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

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

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spring Hill

State/Province

Florida

ZIP/Postal Code

34609

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Conyers

State/Province

Georgia

ZIP/Postal Code

30094-5965

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Council Bluffs

State/Province

Iowa

ZIP/Postal Code

51501

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

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70002

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hyattsville

State/Province

Maryland

ZIP/Postal Code

20782

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48310-3503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Trenton

State/Province

New Jersey

ZIP/Postal Code

08611

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330-3737

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

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

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78413

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

75251

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9302

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Katy

State/Province

Texas

ZIP/Postal Code

77450

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Splendora

State/Province

Texas

ZIP/Postal Code

77372

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Herndon

State/Province

Virginia

ZIP/Postal Code

20171

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801-2028

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1250AAN

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Caba

ZIP/Postal Code

C1093AAS

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Caba

ZIP/Postal Code

C1430CKE

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Rosario

ZIP/Postal Code

S2000CUD

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3S 2N6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7M 4Y1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N5W 6A2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Pointe Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 3J1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500034

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

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682041

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302006

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

600001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700020

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700054

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 15

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 7

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Galway

ZIP/Postal Code

H91 YR71

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Mallow

ZIP/Postal Code

P51Y8EC

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Achrafieh

Country

Lebanon

Facility Name

Novo Nordisk Investigational Site

City

Hazmieh

Country

Lebanon

Facility Name

Novo Nordisk Investigational Site

City

Lebanon - Beirut

ZIP/Postal Code

9611

Country

Lebanon

Facility Name

Novo Nordisk Investigational Site

City

Mansourieh

Country

Lebanon

Facility Name

Novo Nordisk Investigational Site

City

Zgharta

ZIP/Postal Code

9616

Country

Lebanon

Facility Name

Novo Nordisk Investigational Site

City

Alor Gajah

ZIP/Postal Code

78300

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Ipoh

ZIP/Postal Code

30450

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Melaka

ZIP/Postal Code

75400

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Penang

ZIP/Postal Code

10450

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Sandakan

ZIP/Postal Code

90000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Seremban

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Mexico City

State/Province

México, D.F.

ZIP/Postal Code

02230

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64620

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Eksjö

ZIP/Postal Code

575 35

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Kristianstad

ZIP/Postal Code

291 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Basingstoke

ZIP/Postal Code

RG24 9GT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bradford-on-Avon

ZIP/Postal Code

BA15 1DQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Haxey

ZIP/Postal Code

DN9 2HY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Plymouth

ZIP/Postal Code

PL8 8DQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Soham

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Southampton

ZIP/Postal Code

SO30 3JB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Torquay

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Wellingborough

ZIP/Postal Code

NN8 4RW

Country

United Kingdom

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

31540867

Citation

Lingvay I, Catarig AM, Frias JP, Kumar H, Lausvig NL, le Roux CW, Thielke D, Viljoen A, McCrimmon RJ. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):834-844. doi: 10.1016/S2213-8587(19)30311-0. Epub 2019 Sep 17.

Results Reference

result

PubMed Identifier

31897524

Citation

McCrimmon RJ, Catarig AM, Frias JP, Lausvig NL, le Roux CW, Thielke D, Lingvay I. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020 Mar;63(3):473-485. doi: 10.1007/s00125-019-05065-8. Epub 2020 Jan 2.

Results Reference

result

PubMed Identifier

32827435

Citation

Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

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Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN 8)

Diabetes, Diabetes Mellitus, Type 2

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