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Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes (SUSTAIN 10)

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ClinicalTrials.gov Identifier: NCT03191396
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Liraglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : August 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide
Half the study participants are randomised to receive semaglutide
Drug: Semaglutide
Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Active Comparator: Liraglutide
Half the study participants are randomised to receive liraglutide
Drug: Liraglutide
Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 0, week 30 ]
    Measured in %


Secondary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Week 0, week 30 ]
    Measured in kg

  2. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 30 ]
    Measured in mg/dl or other equivalent SI units

  3. Change in self-measured plasma glucose (SMPG), 7 point profile: Mean 7-point profile [ Time Frame: Week 0, week 30 ]
    Mean glucose values

  4. Change in self-measured plasma glucose (SMPG), 7 point profile: Mean post prandial increment (over all meals) [ Time Frame: Week 0, week 30 ]
    Mean glucose value over all meals

  5. Change in fasting blood lipids: total cholesterol [ Time Frame: Week 0, week 30 ]
    Measured in mg/dl or other equivalent SI units

  6. Change in fasting blood lipids: low-density lipoprotein (LDL)-cholesterol [ Time Frame: Week 0, week 30 ]
    Measured in mg/dl or other equivalent SI units

  7. Change in fasting blood lipids: high-density lipoprotein (HDL)-cholesterol [ Time Frame: Week 0, week 30 ]
    Measured in mg/dl or other equivalent SI units

  8. Change in fasting blood lipids: triglycerides [ Time Frame: Week 0, week 30 ]
    Measured in mg/dl or other equivalent SI units

  9. Change in Body Mass Index (BMI) [ Time Frame: Week 0, week 30 ]
    Measured in kg/sqm

  10. Change in waist circumference [ Time Frame: Week 0, week 30 ]
    Measured in cm

  11. Change in systolic blood pressure [ Time Frame: Week 0, week 30 ]
    Measured in mmHg

  12. Change in diastolic blood pressure [ Time Frame: Week 0, week 30 ]
    Measured in mmHg

  13. Change in body weight (%) [ Time Frame: Week 0, week 30 ]
    Measured in %

  14. Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  15. Subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  16. Subjects who achieve weight loss above or equal to 3% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  17. Subjects who achieve weight loss above or equal to 5% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  18. Subjects who achieve weight loss above or equal to 10% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  19. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  20. Subjects who achieve HbA1c reduction above or equal to 1% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  21. Subjects who achieve HbA1c reduction above or equal to 1% and weight loss above or equal to 3% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  22. Subjects who achieve HbA1c reduction above or equal to 1% and weight loss above or equal to 5% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  23. Subjects who achieve HbA1c reduction above or equal to 1% and weight loss above or equal to 10% [ Time Frame: After 30 weeks of treatment ]
    Measured in %

  24. Change in SF-36v2TM Short Form health survey. Total summary scores (physical component and mental component) and scores from the 8 domains [ Time Frame: Week 0, week 30 ]
    Short Form 36 v2.0 (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health

  25. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment satisfaction summary score (sum of 6 of 8 items) and the 8 items separately upportive secondary safety endpoints [ Time Frame: Week 0, week 30 ]
    The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment

  26. Number of treatment-emergent adverse events [ Time Frame: Week 0 to week 35 ]
    Count of episodes

  27. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [ Time Frame: Week 0 to week 35 ]
    Count of episodes

  28. Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes [ Time Frame: Week 0 to week 35 ]
    Yes/no



Information from the National Library of Medicine

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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 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - 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 - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - 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 estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191396


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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03191396     History of Changes
Other Study ID Numbers: NN9535-4339
2016-004965-22 ( Registry Identifier: EudraCT )
U1111-1190-5868 ( Other Identifier: World Health Organization (WHO) )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists