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

May 28, 2019 updated by: Novo Nordisk A/S
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J 1S3
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Novo Nordisk Investigational Site
    • Ontario
      • London, Ontario, Canada, N6P 1A9
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Novo Nordisk Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Novo Nordisk Investigational Site
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • Novo Nordisk Investigational Site
  • Italy
      • Catania, Italy, 95122
        • Novo Nordisk Investigational Site
      • Pisa, Italy, 56124
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00133
        • Novo Nordisk Investigational Site
      • Rome, Italy, 00168
        • Novo Nordisk Investigational Site
      • Siena, Italy, 53100
        • Novo Nordisk Investigational Site
      • Terni, Italy, 05100
        • Novo Nordisk Investigational Site
  • Japan
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Novo Nordisk Investigational Site
      • Suita-shi, Osaka, Japan, 565-0853
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0027
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0028
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 160-0008
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64620
        • Novo Nordisk Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 010507
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 13682
        • Novo Nordisk Investigational Site
      • Buzau, Romania, 120203
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800578
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Novo Nordisk Investigational Site
      • Arkhangelsk, Russian Federation, 163001
        • Novo Nordisk Investigational Site
      • Chelyabinsk, Russian Federation, 454048
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420073
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petesburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355035
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1739
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0084
        • Novo Nordisk Investigational Site
      • Sophiatown, Gauteng, South Africa, 2129
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
      • Umkomaas, KwaZulu-Natal, South Africa, 4170
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Cardiff, United Kingdom, CF5 4AD
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD2 5NH
        • Novo Nordisk Investigational Site
      • St Helens, United Kingdom, WA9 3DA
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA2 8PP
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Pell City, Alabama, United States, 35128
        • Novo Nordisk Investigational Site
    • California
      • Hawaiian Gardens, California, United States, 90716
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91324
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32277
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33143
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33144
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33174
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33015
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Novo Nordisk Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Novo Nordisk Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Novo Nordisk Investigational Site
    • New Jersey
      • Belvidere, New Jersey, United States, 07823
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Delaware, Ohio, United States, 43015
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Novo Nordisk Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Sealy, Texas, United States, 77474
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Semaglutide placebo 0.5 mg
Drug: placebo
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)
Experimental: Semaglutide 0.5 mg
Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)
Experimental: Semaglutide 1.0 mg
Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 30
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.
Week 0, week 30
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.
Week 0, week 30
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.
At 30 weeks of treatment
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.
At 30 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2014

Primary Completion (Actual)

May 8, 2015

Study Completion (Actual)

May 8, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-3623
  • 2013-000632-94 (EudraCT Number)
  • U1111-1139-3090 (Other Identifier: WHO)
  • JapicCTI-142442 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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