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Trial record 1 of 2263 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
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 388
Actual Study Start Date: February 3, 2014
Study Completion Date: May 8, 2015
Primary Completion Date: May 8, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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
  Contacts and Locations
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): NCT02054897


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Anniston, Alabama, United States, 36207
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
Novo Nordisk Investigational Site
Pell City, Alabama, United States, 35128
United States, California
Novo Nordisk Investigational Site
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
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80920
United States, Florida
Novo Nordisk Investigational Site
Boynton Beach, Florida, United States, 33472
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32277
Novo Nordisk Investigational Site
Miami Lakes, Florida, United States, 33016
Novo Nordisk Investigational Site
Miami, Florida, United States, 33015
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, 33173
Novo Nordisk Investigational Site
Miami, Florida, United States, 33174
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Novo Nordisk Investigational Site
Savannah, Georgia, United States, 31406
United States, Indiana
Novo Nordisk Investigational Site
Brownsburg, Indiana, United States, 46112
Novo Nordisk Investigational Site
Franklin, Indiana, United States, 46131
United States, Iowa
Novo Nordisk Investigational Site
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40504
United States, Mississippi
Novo Nordisk Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, Montana
Novo Nordisk Investigational Site
Billings, Montana, United States, 59101
United States, New Jersey
Novo Nordisk Investigational Site
Belvidere, New Jersey, United States, 07823
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28277
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States, 28472
United States, Ohio
Novo Nordisk Investigational Site
Delaware, Ohio, United States, 43015
United States, Pennsylvania
Novo Nordisk Investigational Site
Levittown, Pennsylvania, United States, 19056
United States, South Carolina
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Novo Nordisk Investigational Site
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
Canada, British Columbia
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Manitoba
Novo Nordisk Investigational Site
Winnipeg, Manitoba, Canada, R2V 4W3
Canada, Ontario
Novo Nordisk Investigational Site
London, Ontario, Canada, N6P 1A9
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Canada, Quebec
Novo Nordisk Investigational Site
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
Italy
Novo Nordisk Investigational Site
Catania, Italy, 95122
Novo Nordisk Investigational Site
Pisa, Italy, 56124
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00168
Novo Nordisk Investigational Site
Siena, Italy, 53100
Novo Nordisk Investigational Site
Terni, Italy, 05100
Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
Novo Nordisk Investigational Site
Kyoto-shi, Kyoto, Japan, 606-8507
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-0008
Novo Nordisk Investigational Site
Suita-shi, Osaka, Japan, 565-0853
Novo Nordisk Investigational Site
Tokyo, Japan, 103-0028
Mexico
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 64620
Novo Nordisk Investigational Site
Tampico, Tamaulipas, Mexico, 89000
Novo Nordisk Investigational Site
Aguascalientes, Mexico, 20230
Romania
Novo Nordisk Investigational Site
Oradea, Bihor, Romania, 410469
Novo Nordisk Investigational Site
Bucharest, Romania, 010507
Novo Nordisk Investigational Site
Bucharest, Romania, 13682
Novo Nordisk Investigational Site
Buzau, Romania, 120203
Novo Nordisk Investigational Site
Galati, Romania, 800578
Russian Federation
Novo Nordisk Investigational Site
Arkhangelsk, Russian Federation, 163001
Novo Nordisk Investigational Site
Arkhangelsk, Russian Federation, 163045
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, 355017
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1827
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
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site
Umkomaas, KwaZulu-Natal, South Africa, 4170
United Kingdom
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02054897     History of Changes
Other Study ID Numbers: NN9535-3623
2013-000632-94 ( EudraCT Number )
U1111-1139-3090 ( Other Identifier: WHO )
JapicCTI-142442 ( Registry Identifier: JAPIC )
First Submitted: February 3, 2014
First Posted: February 4, 2014
Last Update Posted: November 17, 2017
Last Verified: November 2017

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