Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™ 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02054897
First received: February 3, 2014
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (Glycosylated haemoglobin) [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in Fasting plasma glucose (FPG) [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in Systolic and diastolic blood pressure [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Subjects who achieve (yes/no):HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target [ Time Frame: After 30 weeks treatment ] [ Designated as safety issue: No ]
  • Subjects who achieve (yes/no):HbA1c below or equal to 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target [ Time Frame: After 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: February 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semaglutide 1.0 mg Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)
Experimental: Semaglutide 0.5 mg Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)
Placebo Comparator: Semaglutide placebo 1.0 mg Drug: placebo
Once weekly, administrated subcutaneously (s.c. under the skin)
Placebo Comparator: Semaglutide placebo 0.5 mg Drug: placebo
Once weekly, administrated subcutaneously (s.c. under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent
  • Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
  • HbA1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value above or equal to 50 ng/L (pg/mL)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Impaired renal function defined as eGFR (epidermal growth factor receptor ) below 30 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 class IV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054897

  Show 42 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02054897     History of Changes
Other Study ID Numbers: NN9535-3623, 2013-000632-94, U1111-1139-3090, JapicCTI- 142442
Study First Received: February 3, 2014
Last Updated: September 3, 2014
Health Authority: Canada: Public Health Agency of Canada
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Mexico: National Institute of Public Health, Health Secretariat
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014