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Trial record 1 of 2260 for:    SUSTAIN 1
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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054897
First Posted: February 4, 2014
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 3, 2014
February 4, 2014
November 17, 2017
February 3, 2014
May 8, 2015   (Final data collection date for primary outcome measure)
Change in HbA1c (Glycosylated haemoglobin) [ Time Frame: Week 0, week 30 ]
Same as current
Complete list of historical versions of study NCT02054897 on ClinicalTrials.gov Archive Site
  • Change in body weight [ Time Frame: Week 0, week 30 ]
  • Change in Fasting plasma glucose (FPG) [ Time Frame: Week 0, week 30 ]
  • Change in Systolic and diastolic blood pressure [ Time Frame: Week 0, week 30 ]
  • Subjects who achieve (yes/no):HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target [ Time Frame: After 30 weeks treatment ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    Once weekly, administrated subcutaneously (s.c. under the skin)
  • Drug: placebo
    Once weekly, administrated subcutaneously (s.c. under the skin)
  • Experimental: Semaglutide 1.0 mg
    Intervention: Drug: semaglutide
  • Experimental: Semaglutide 0.5 mg
    Intervention: Drug: semaglutide
  • Placebo Comparator: Semaglutide placebo 1.0 mg
    Intervention: Drug: placebo
  • Placebo Comparator: Semaglutide placebo 0.5 mg
    Intervention: Drug: placebo
Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, Bain SC. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017 Apr;5(4):251-260. doi: 10.1016/S2213-8587(17)30013-X. Epub 2017 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
May 8, 2015
May 8, 2015   (Final data collection date for primary outcome measure)

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 (estimated glomerular filtration rate ) 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy,   Japan,   Mexico,   Romania,   Russian Federation,   South Africa,   United Kingdom,   United States
 
 
NCT02054897
NN9535-3623
2013-000632-94 ( EudraCT Number )
U1111-1139-3090 ( Other Identifier: WHO )
JapicCTI-142442 ( Registry Identifier: JAPIC )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP