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

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ClinicalTrials.gov Identifier: NCT02054897
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : January 23, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 4, 2014
Results First Submitted Date  ICMJE December 22, 2017
Results First Posted Date  ICMJE January 23, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE February 3, 2014
Actual Primary Completion Date May 8, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 30 ]
Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 30 ]
Change History Complete list of historical versions of study NCT02054897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Change in Body Weight [ Time Frame: Week 0, week 30 ]
    Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 30 ]
    Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
  • Change in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, week 30 ]
    Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
  • Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target [ Time Frame: At 30 weeks of treatment ]
    Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c 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.
  • Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target [ Time Frame: At 30 weeks of treatment ]
    Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Official Title  ICMJE Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    Once weekly, administrated subcutaneously (s.c. under the skin)
  • Drug: placebo
    Once weekly, administrated subcutaneously (s.c. under the skin)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2015)
388
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2014)
390
Actual Study Completion Date  ICMJE May 8, 2015
Actual Primary Completion Date May 8, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Italy,   Japan,   Mexico,   Romania,   Russian Federation,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054897
Other Study ID Numbers  ICMJE NN9535-3623
2013-000632-94 ( EudraCT Number )
U1111-1139-3090 ( Other Identifier: WHO )
JapicCTI-142442 ( Registry Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2019

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