Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Last updated: May 28, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Kidney Disease

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT02054897
NN9535-3623
JapicCTI-142442
2013-000632-94
U1111-1139-3090
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at thetime of signing inform consent - Subjects diagnosed with type 2 diabetes and treated withdiet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86

Exclusion

mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding orintends to become pregnant or is of child-bearing potential and not using adequatecontraceptive method (adequate contraceptive measures as required by local regulation orpractice) throughout the trial including the 5 week follow-up period. United Kingdom:Adequate contraceptive measures are defined as established use of oral, injected orimplanted hormonal methods of contraception, placement of an intrauterine device orintrauterine system, barrier methods of contraception (condom or occlusive cap withspermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is solepartner 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, mightjeopardise subject's safety or compliance with the protocol - Treatment with any glucoselowering agent(s) in a period of 90 days prior to screening. An exception is short-termtreatment (no longer than 7 days in total) with insulin in connection with inter-currentillness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin valueabove or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroidcarcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal functiondefined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 permodification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronaryor cerebrovascular event within 90 days before randomisation - Heart failure, New YorkHeart Association class IV

Study Design

Total Participants: 388
Study Start date:
February 03, 2014
Estimated Completion Date:
May 08, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Vancouver, British Columbia V6J 1S3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba R2V 4W3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N6P 1A9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M3J 1N2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe-Claire, Quebec H9R 4S3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Trois Rivières, Quebec G8T 7A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Westmount, Quebec H3Z 1E5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Catania, 95122
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Pisa, 56124
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00133
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Rome, 00168
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Siena, 53100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Terni, 05100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyoto-shi, Kyoto, 606-8507
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shinjuku-ku, Tokyo, 160-0022
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka, 565-0853
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 160-0008
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León 64620
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampico, Tamaulipas 89000
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Oradea, Bihor 410469
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Bucharest, 010507
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Buzau, 120203
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Galati, 800578
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Chelyabinsk, 454048
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420073
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630047
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 194358
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petesburg, 195257
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Stavropol, 355035
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape 6014
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 1827
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Krugersdorp, Gauteng 1739
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0084
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Sophiatown, Gauteng 2129
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Umkomaas, KwaZulu-Natal 4170
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Cardiff, CF5 4AD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Dundee, DD2 5NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    St Helens, WA9 3DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Swansea, SA2 8PP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pell City, Alabama 35128
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Chino, California 91710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hawaiian Gardens, California 90716
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montclair, California 91763
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northridge, California 91324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado 80920
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32277
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33174
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brownsburg, Indiana 46112
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Indiana 46131
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky 41017-3464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Billings, Montana 59101
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Belvidere, New Jersey 07823
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina 28472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Levittown, Pennsylvania 19056
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Penndel, Pennsylvania 19047
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sealy, Texas 77474
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Sugarland, Texas 77479
    United States

    Site Not Available

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