Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes. (SUSTAIN 7)

• ClinicalTrials.gov Identifier: NCT02648204
• Recruitment Status: Completed
• First Posted: January 6, 2016
• Results First Posted: May 8, 2018
• Last Update Posted: October 15, 2019
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Condition or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: semaglutide; Drug: Dulaglutide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes
• Actual Study Start Date: January 6, 2016
• Actual Primary Completion Date: April 10, 2017
• Actual Study Completion Date: May 19, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Semaglutide 0.5 mg/Week	Drug: semaglutide; Administered subcutaneously (s.c., under the skin) once-weekly.
Experimental: Semaglutide 1.0 mg/Week	Drug: semaglutide; Administered subcutaneously (s.c., under the skin) once-weekly.
Active Comparator: Dulaglutide 0.75 mg/Week	Drug: Dulaglutide; Administered subcutaneously (s.c., under the skin) once-weekly.
Active Comparator: Dulaglutide 1.5 mg/Week	Drug: Dulaglutide; Administered subcutaneously (s.c., under the skin) once-weekly.

Outcome Measures

Primary Outcome Measures :

1. Change in HbA1c [ Time Frame: Week 0, week 40 ]
   Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Secondary Outcome Measures :

1. Change in Body Weight (kg) [ Time Frame: Week 0, week 40 ]
   Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
2. Change in Fasting Plasma Glucose [ Time Frame: Week 0, week 40 ]
   Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
3. Change in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, week 40 ]
   Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
4. Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire [ Time Frame: Week 0, week 40 ]
   The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication
5. HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target [ Time Frame: After 40 weeks treatment ]
   Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
6. Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile [ Time Frame: Week 0, week 40 ]
   SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
7. Change From Baseline 7-point Self-measured Plasma Glucose Increment [ Time Frame: Week 0, week 40 ]
   SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
8. Change in Fasting Blood Lipids (Total Cholesterol) [ Time Frame: Week 0, week 40 ]
   Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
9. Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) [ Time Frame: Week 0, week 40 ]
   Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
10. Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
11. Change in Fasting Blood Lipids (Triglycerides) [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
12. Change in Body Mass Index (BMI) [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
13. Change in Waist Circumference [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
14. Change in Short Form Health Survey (SF-36v2™) [ Time Frame: Week 0, week 40 ]
    The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
15. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target [ Time Frame: After 40 weeks of treatment ]
    Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
16. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% [ Time Frame: After 40 weeks treatment ]
    Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
17. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% [ Time Frame: After 40 weeks treatment ]
    Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
18. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain [ Time Frame: After 40 weeks of treatment ]
    Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
19. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% [ Time Frame: After 40 weeks of treatment ]
    Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
20. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% [ Time Frame: After 40 weeks treatment ]
    Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
21. Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% [ Time Frame: After 40 weeks treatment ]
    Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
22. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 40 weeks + follow-up of 5 weeks ]
    A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).
23. Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes [ Time Frame: 40 weeks + follow-up of 5 weeks ]
    A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
24. Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: 40 weeks + follow-up of 5 weeks ]
    Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
25. Change in Amylase [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
26. Change in Lipase [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
27. Change in Pulse Rate [ Time Frame: Week 0, week 40 ]
    Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - 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 measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Contacts and Locations

Locations

United States, Alabama

Novo Nordisk Investigational Site

Tuscumbia, Alabama, United States, 35674

United States, Arizona

Novo Nordisk Investigational Site

Chandler, Arizona, United States, 85224

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Phoenix, Arizona, United States, 85032

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Phoenix, Arizona, United States, 85050

United States, California

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Anaheim, California, United States, 92801

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Buena Park, California, United States, 90620

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Carlsbad, California, United States, 92008

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Concord, California, United States, 94520

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Huntington Park, California, United States, 90255

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Lincoln, California, United States, 95648

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Los Angeles, California, United States, 90057

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Montclair, California, United States, 91763

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Poway, California, United States, 92064

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Riverside, California, United States, 92506

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San Diego, California, United States, 92103

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Tustin, California, United States, 92780

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Van Nuys, California, United States, 91405

United States, Colorado

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Denver, Colorado, United States, 80220

United States, Connecticut

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Norwalk, Connecticut, United States, 06851

United States, Florida

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Clearwater, Florida, United States, 33756

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Clearwater, Florida, United States, 33761

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Coral Gables, Florida, United States, 33134

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Edgewater, Florida, United States, 32132

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Fort Lauderdale, Florida, United States, 33316

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Kissimmee, Florida, United States, 34741

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Miami, Florida, United States, 33173

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Orlando, Florida, United States, 32804

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Orlando, Florida, United States, 32806

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Pembroke Pines, Florida, United States, 33027

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Port Orange, Florida, United States, 32127

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Tampa, Florida, United States, 33614

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Tampa, Florida, United States, 33634

United States, Georgia

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Adairsville, Georgia, United States, 30103

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Atlanta, Georgia, United States, 30342

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Bainbridge, Georgia, United States, 39819

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Conyers, Georgia, United States, 30094-5965

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Marietta, Georgia, United States, 30060

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Marietta, Georgia, United States, 30067

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Suwanee, Georgia, United States, 30024

United States, Idaho

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Meridian, Idaho, United States, 83646

United States, Illinois

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Addison, Illinois, United States, 60101

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Chicago, Illinois, United States, 60607

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Gillespie, Illinois, United States, 62033

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Gurnee, Illinois, United States, 60031

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Peoria, Illinois, United States, 61602

United States, Indiana

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Avon, Indiana, United States, 46123

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Evansville, Indiana, United States, 47714

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Greenfield, Indiana, United States, 46140

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Indianapolis, Indiana, United States, 46254

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Muncie, Indiana, United States, 47304

United States, Kansas

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Newton, Kansas, United States, 67114

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Park City, Kansas, United States, 67219

United States, Kentucky

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Covington, Kentucky, United States, 41011

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Louisville, Kentucky, United States, 40213

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Owensboro, Kentucky, United States, 42303

United States, Maryland

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Hyattsville, Maryland, United States, 20782

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Oxon Hill, Maryland, United States, 20745

United States, Massachusetts

Novo Nordisk Investigational Site

Methuen, Massachusetts, United States, 01844

United States, Michigan

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Rochester, Michigan, United States, 48307

United States, Mississippi

Novo Nordisk Investigational Site

Port Gibson, Mississippi, United States, 39150

United States, Montana

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Missoula, Montana, United States, 59808

United States, New Jersey

Novo Nordisk Investigational Site

Trenton, New Jersey, United States, 08611

United States, New York

Novo Nordisk Investigational Site

New York, New York, United States, 10016

United States, North Carolina

Novo Nordisk Investigational Site

Garner, North Carolina, United States, 27529

Novo Nordisk Investigational Site

Whiteville, North Carolina, United States, 28472

Novo Nordisk Investigational Site

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States, 45242

Novo Nordisk Investigational Site

Dayton, Ohio, United States, 45439

Novo Nordisk Investigational Site

Mason, Ohio, United States, 45040-6815

Novo Nordisk Investigational Site

Wadsworth, Ohio, United States, 44281-9236

United States, Oklahoma

Novo Nordisk Investigational Site

Tulsa, Oklahoma, United States, 74136

United States, Oregon

Novo Nordisk Investigational Site

Corvallis, Oregon, United States, 97330-3737

United States, Pennsylvania

Novo Nordisk Investigational Site

Fleetwood, Pennsylvania, United States, 19522

Novo Nordisk Investigational Site

Harleysville, Pennsylvania, United States, 19438

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States, 19114

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States, 15224-2215

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States, 15236

United States, South Carolina

Novo Nordisk Investigational Site

Greer, South Carolina, United States, 29651

Novo Nordisk Investigational Site

Moncks Corner, South Carolina, United States, 29461

Novo Nordisk Investigational Site

Spartanburg, South Carolina, United States, 29303

United States, South Dakota

Novo Nordisk Investigational Site

Rapid City, South Dakota, United States, 57702

United States, Tennessee

Novo Nordisk Investigational Site

Humboldt, Tennessee, United States, 38343

United States, Texas

Novo Nordisk Investigational Site

Arlington, Texas, United States, 76015

Novo Nordisk Investigational Site

Corpus Christi, Texas, United States, 78404

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75230

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75390-9302

Novo Nordisk Investigational Site

Houston, Texas, United States, 77025

Novo Nordisk Investigational Site

Houston, Texas, United States, 77040

Novo Nordisk Investigational Site

Houston, Texas, United States, 77074

Novo Nordisk Investigational Site

Houston, Texas, United States, 77079

Novo Nordisk Investigational Site

Houston, Texas, United States, 77081

Novo Nordisk Investigational Site

Houston, Texas, United States, 77090

Novo Nordisk Investigational Site

Katy, Texas, United States, 77450

Novo Nordisk Investigational Site

San Antonio, Texas, United States, 78231

Novo Nordisk Investigational Site

Sugar Land, Texas, United States, 77479

United States, Utah

Novo Nordisk Investigational Site

Riverton, Utah, United States, 84065

Novo Nordisk Investigational Site

Saint George, Utah, United States, 84790

United States, Washington

Novo Nordisk Investigational Site

Spokane, Washington, United States, 99216-1557

Novo Nordisk Investigational Site

Walla Walla, Washington, United States, 99362-4445

Novo Nordisk Investigational Site

Wenatchee, Washington, United States, 98801-2028

Bulgaria

Novo Nordisk Investigational Site

Blagoevgrad, Bulgaria, 2700

Novo Nordisk Investigational Site

Burgas, Bulgaria, 8000

Novo Nordisk Investigational Site

Montana, Bulgaria, 3400

Novo Nordisk Investigational Site

Sofia, Bulgaria, 1233

Novo Nordisk Investigational Site

Stara Zagora, Bulgaria, 6000

Croatia

Novo Nordisk Investigational Site

Karlovac, Croatia, 47000

Novo Nordisk Investigational Site

Krapinske Toplice, Croatia, 49217

Novo Nordisk Investigational Site

Rijeka, Croatia, 51 000

Novo Nordisk Investigational Site

Varazdin, Croatia, 42 000

Novo Nordisk Investigational Site

Virovitica, Croatia, 33000

Novo Nordisk Investigational Site

Zagreb, Croatia, 10 000

Finland

Novo Nordisk Investigational Site

Jyväskylä, Finland, 40100

Novo Nordisk Investigational Site

Kerava, Finland, FI-04200

Novo Nordisk Investigational Site

Kuusamo, Finland, 93600

Novo Nordisk Investigational Site

Raisio, Finland, 21200

Novo Nordisk Investigational Site

Tampere, Finland, 33210

Novo Nordisk Investigational Site

Turku, Finland, 20520

Germany

Novo Nordisk Investigational Site

Dresden, Germany, 01219

Novo Nordisk Investigational Site

Falkensee, Germany, 14612

Novo Nordisk Investigational Site

Friedrichsthal, Germany, 66299

Novo Nordisk Investigational Site

Hamburg, Germany, 22607

Novo Nordisk Investigational Site

Münster, Germany, 48145

Novo Nordisk Investigational Site

Rehlingen-Siersburg, Germany, 66780

Novo Nordisk Investigational Site

Saint Ingbert-Oberwürzbach, Germany, 66386

Greece

Novo Nordisk Investigational Site

Athens, Greece, 115 25

Novo Nordisk Investigational Site

Athens, Greece, GR-17562

Novo Nordisk Investigational Site

Chalkida, Evia, Greece, GR-34100

Novo Nordisk Investigational Site

Ioannina, Greece, 45500

Novo Nordisk Investigational Site

Piraeus, Greece, GR-18536

Novo Nordisk Investigational Site

Thessaloniki, Greece, GR-54636

Novo Nordisk Investigational Site

Thessaloniki, Greece, GR-57001

Novo Nordisk Investigational Site

Thessaloniki, Greece, GR-57010

Hong Kong

Novo Nordisk Investigational Site

Shatin, New Territories, Hong Kong

India

Novo Nordisk Investigational Site

Guntur, Andhra Pradesh, India, 522001

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India, 500004

Novo Nordisk Investigational Site

Visakhapatnam, Andhra Pradesh, India, 530002

Novo Nordisk Investigational Site

Guwahati, Assam, India, 781008

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India, 380007

Novo Nordisk Investigational Site

Bangalore, Karnataka, India, 560002

Novo Nordisk Investigational Site

Bangalore, Karnataka, India, 560054

Novo Nordisk Investigational Site

Kochi, Kerala, India, 682041

Novo Nordisk Investigational Site

Kozhikode, Kerala, India, 673017

Novo Nordisk Investigational Site

Indore, Madhya Pradesh, India, 452008

Novo Nordisk Investigational Site

Goa, Maharashtra, India, 403 202

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India, 400008

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India, 400022

Novo Nordisk Investigational Site

Pune, Maharashtra, India, 411004

Novo Nordisk Investigational Site

Pune, Maharashtra, India, 411040

Novo Nordisk Investigational Site

Delhi, New Delhi, India, 110002

Novo Nordisk Investigational Site

New Dehli, New Delhi, India, 110029

Novo Nordisk Investigational Site

Bhubaneswar, Orissa, India, 751005

Novo Nordisk Investigational Site

Mohali, Punjab, India, 160062

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India, 600086

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, India, 632004

Novo Nordisk Investigational Site

Kolkata, West Bengal, India, 700017

Novo Nordisk Investigational Site

Kolkata, West Bengal, India, 700020

Novo Nordisk Investigational Site

Hyderabad, India, 500 012

Novo Nordisk Investigational Site

Ludhiana, India, 141001

Novo Nordisk Investigational Site

New Delhi, India, 110001

Ireland

Novo Nordisk Investigational Site

Dublin, Ireland, DUBLIN 15

Novo Nordisk Investigational Site

Dublin, Ireland, DUBLIN 4

Novo Nordisk Investigational Site

Dublin, Ireland, DUBLIN 7

Novo Nordisk Investigational Site

Galway, Ireland, H91 YR71

Novo Nordisk Investigational Site

Gorey, Ireland

Latvia

Novo Nordisk Investigational Site

Riga, Latvia, LV-1002

Novo Nordisk Investigational Site

Riga, Latvia, LV-1024

Novo Nordisk Investigational Site

Riga, Latvia, LV-1038

Lithuania

Novo Nordisk Investigational Site

Kaunas, Lithuania, 48259

Novo Nordisk Investigational Site

Kaunas, Lithuania, 50009

Novo Nordisk Investigational Site

Panevezys, Lithuania, 37355

Novo Nordisk Investigational Site

Vilnius, Lithuania, 04318

Novo Nordisk Investigational Site

Vilnius, Lithuania, 08661

Portugal

Novo Nordisk Investigational Site

Almada, Portugal, 2805-267

Novo Nordisk Investigational Site

Aveiro, Portugal, 3814-501

Novo Nordisk Investigational Site

Lisboa, Portugal, 1250-230

Novo Nordisk Investigational Site

Tomar, Portugal, 2304-909

Novo Nordisk Investigational Site

Viana do Castelo, Portugal, 4901-858

Novo Nordisk Investigational Site

Vila Nova de Gaia, Portugal, 4434-502

Puerto Rico

Novo Nordisk Investigational Site

Ponce, Puerto Rico, 00716

Romania

Novo Nordisk Investigational Site

Oradea, Bihor, Romania, 410469

Novo Nordisk Investigational Site

Tirgu Mures, Mures, Romania, 540142

Novo Nordisk Investigational Site

Brasov, Romania, 500101

Novo Nordisk Investigational Site

Bucharest, Romania, 010507

Novo Nordisk Investigational Site

Bucharest, Romania, 13682

Novo Nordisk Investigational Site

Buzau, Romania, 120203

Novo Nordisk Investigational Site

Galati, Romania, 800578

Slovakia

Novo Nordisk Investigational Site

Bratislava, Slovakia, 81108

Novo Nordisk Investigational Site

Bratislava, Slovakia, 851 01

Novo Nordisk Investigational Site

Levice, Slovakia, 93401

Novo Nordisk Investigational Site

Piestany, Slovakia, 92101

Novo Nordisk Investigational Site

Poprad, Slovakia, 05801

Novo Nordisk Investigational Site

Prievidza, Slovakia, 97101

Spain

Novo Nordisk Investigational Site

Alicante, Spain, 03010

Novo Nordisk Investigational Site

La Roca del Vallés, Spain, 08430

Novo Nordisk Investigational Site

Madrid, Spain, 28009

Novo Nordisk Investigational Site

Málaga, Spain, 29006

Novo Nordisk Investigational Site

Palma de Mallorca, Spain, 07010

Novo Nordisk Investigational Site

Palma de Mallorca, Spain, 07014

Novo Nordisk Investigational Site

Segovia, Spain, 40002

Novo Nordisk Investigational Site

Sevilla, Spain, 41010

Novo Nordisk Investigational Site

Vic (Barcelona), Spain, 08500

United Kingdom

Novo Nordisk Investigational Site

Bradford-on-Avon, United Kingdom, BA15 1DQ

Novo Nordisk Investigational Site

Northwood, United Kingdom, HA6 2RN

Novo Nordisk Investigational Site

Romford, United Kingdom, RM1 3PJ

Novo Nordisk Investigational Site

Soham, United Kingdom, CB7 5JD

Novo Nordisk Investigational Site

Southampton, United Kingdom, SO16 6YD

Novo Nordisk Investigational Site

Southampton, United Kingdom, SO30 3JB

Novo Nordisk Investigational Site

Stevenage, United Kingdom, SG1 4AB

Novo Nordisk Investigational Site

Watford, United Kingdom, WD25 7NL

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:

Study Protocol  [PDF] November 30, 2017

Statistical Analysis Plan  [PDF] November 30, 2017

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1.

Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29.

Wilkinson L, Hunt B, Johansen P, Iyer NN, Dang-Tan T, Pollock RF. Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States. Diabetes Ther. 2018 Jun;9(3):951-961. doi: 10.1007/s13300-018-0402-8. Epub 2018 Mar 19.

Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.

Viljoen A, Hoxer CS, Johansen P, Malkin S, Hunt B, Bain SC. Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK. Diabetes Obes Metab. 2019 Mar;21(3):611-621. doi: 10.1111/dom.13564. Epub 2018 Nov 28.

Other Publications:

Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

Johansen P, Hakan-Bloch J, Liu AR, Bech PG, Persson S, Leiter LA. Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada. Pharmacoecon Open. 2019 Dec;3(4):537-550. doi: 10.1007/s41669-019-0131-6.

Malkin SJP, Russel-Szymczyk M, Psota M, Hlavinkova L, Hunt B. The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia. Adv Ther. 2019 Aug;36(8):2034-2051. doi: 10.1007/s12325-019-00965-y. Epub 2019 Jun 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pratley RE, Aroda VR, Catarig AM, Lingvay I, Ludemann J, Yildirim E, Viljoen A. Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses. BMJ Open. 2020 Nov 16;10(11):e037883. doi: 10.1136/bmjopen-2020-037883.

DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02648204
• Other Study ID Numbers: NN9535-4216; 2014-005375-91 ( EudraCT Number ); U1111-1164-8495 ( Other Identifier: WHO )
• First Posted: January 6, 2016
• Results First Posted: May 8, 2018
• Last Update Posted: October 15, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Dulaglutide; Hypoglycemic Agents; Physiological Effects of Drugs