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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT) (SUSTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03061214
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Semaglutide 0.5 mg Drug: Semaglutide 1.0 mg Drug: Sitagliptin placebo Drug: Sitagliptin Drug: Semaglutide placebo 0.5 mg Drug: Semaglutide placebo 1.0 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 868 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes. A 30-week Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-centre and Multi-national Trial
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide 0.5 mg OW + sitagliptin placebo OD Drug: Semaglutide 0.5 mg
Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks

Drug: Sitagliptin placebo
Sitagliptin placebo tablets taken once-daily for 30 weeks

Experimental: Semaglutide 1 mg OW + sitagliptin placebo OD Drug: Semaglutide 1.0 mg
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks

Drug: Sitagliptin placebo
Sitagliptin placebo tablets taken once-daily for 30 weeks

Active Comparator: Sitagliptin OD + semaglutide placebo 0.5 mg OW Drug: Sitagliptin
100 mg sitagliptin tablets taken once-daily for 30 weeks

Drug: Semaglutide placebo 0.5 mg
Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks

Active Comparator: Sitagliptin OD + semaglutide placebo 1 mg OW Drug: Sitagliptin
100 mg sitagliptin tablets taken once-daily for 30 weeks

Drug: Semaglutide placebo 1.0 mg
Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks




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


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: Week 0, week 30 ]
    Measured in kg and/or %

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

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

  5. Change in patient reported outcome (PRO) questionnaire: Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score [ 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.

  6. Subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol) - American Association of Clinical Endocrinologists (AACE) (yes/no) [ Time Frame: After 30 weeks ]
    Proportion of subjects

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

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

  9. Change in body mass index (BMI) [ Time Frame: Week 0, week 30 ]
    Measured in kg/m^2

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

  11. Change in patient reported outcome (PRO) questionnaire: SF-36v2(TM) score [ Time Frame: Week 0, week 30 ]
    Short Form 36 v2.0 acute (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

  12. Subjects who achieve HbA1c below or equal to 7.0% (53 mmol/mol) - American Diabetes Association (ADA) target (yes/no) [ Time Frame: Week 30 ]
    Proportion of subjects

  13. Achievement of weight loss greater than or equal to 5% [ Time Frame: Week 30 ]
    Proportion of subjects

  14. Achievement of weight loss greater than or equal to 10% [ Time Frame: Week 30 ]
    Proportion of subjects

  15. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and no weight gain [ Time Frame: Week 30 ]
    Proportion of subjects - fulfilling both criteria

  16. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Week 0 - week 30 ]
    Count and % of adverse events

  17. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes [ Time Frame: Week 0 - week 30 ]
    Count of events

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

  19. 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

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

  21. 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

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

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



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: - 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 above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV

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): NCT03061214


Locations
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Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03061214    
Other Study ID Numbers: NN9535-4114
U1111-1149-0432 ( Other Identifier: World Health Organization (WHO) )
CTR20161003 ( Registry Identifier: China Drug Trials (China) )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
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
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action