Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

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

Phase

3

Condition

Diabetic Kidney Disease

Diabetic Foot Ulcers

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT02305381
NN9535-3627
U1111-1149-3738
JapicCTI-142729
2013-004502-26
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informconsent. For Japan: Male or female, age at least 20 years at the time of signing informedconsent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetestreatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludecand/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day ormaximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin)

Exclusion

7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who ispregnant, breast-feeding or intends to become pregnant or is of child-bearing potential andnot using an adequate contraceptive method throughout the trial including the 5 weeksfollow-up period (adequate contraceptive measures as required by local regulation orpractice). Germany: Only highly effective methods of birth control are accepted (ie onethat results in less than 1% per year failure rate when used consistently and correctlysuch as implants, injectables, combined oral contraceptives, some intrauterine device), orsexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures areabstinence (not having sex), diaphragm, condom (by the partner), intrauterine device,sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agentsother than stated in the inclusion criteria in a period of 90 days before screening. Anexception is short-term treatment (7 days or less in total) with bolus insulin inconnection with intercurrent illness - Experienced more than 3 episodes of severehypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness -History of pancreatitis (acute or chronic) - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) ormultiple endocrine neoplasia syndrome 2 (MEN 2) - Severe renal impairment defined as eGFR (estimated glomerular filtration rate) below 30 mL/min/1.73 m^2 per Modification of Diet inRenal Disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular eventwithin 90 days before randomisation - Heart failure, New York Heart Association (NYHA)Class IV

Study Design

Total Participants: 397
Study Start date:
December 01, 2014
Estimated Completion Date:
November 21, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Essen, 45219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Friedrichsthal, 66299
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22587
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Sulzbach-Rosenberg, 92237
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Ibaraki, 311-0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kashiwara-shi, Osaka, 582-0005
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kumamoto,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kumamoto-shi, Kumamoto, 860-0811
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Miyazaki, 880-0034
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Miyazaki-shi, 880 0034
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Miyazaki-shi, Miyazaki, 880-0034
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Naka-shi, 311 0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Naka-shi, Ibaraki, 311 0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Osaka, 569-1045
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Takatsuki-shi, Osaka, 569 1096
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bratislava, 833 05
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Levice, 93401
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Lucenec, 984 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Presov, 080 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Fair Oaks, California 95628
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057-3550
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northridge, California 91325
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Poway, California 92064
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Riverside, California 92506
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roseville, California 95661
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Ramon, California 94583
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Van Nuys, California 91405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Hills, California 91307
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spring Hill, Florida 34609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33634
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gillespie, Illinois 62033
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Avon, Indiana 46123
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Overland Park, Kansas 66209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    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 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Paducah, Kentucky 42003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waltham, Massachusetts 02453
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Flint, Michigan 48532
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jackson, Mississippi 39209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45439
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73162-4704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Levittown, Pennsylvania 19056-2404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, Tennessee 37303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620-7352
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77008
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hurst, Texas 76054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Katy, Texas 77450
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pasadena, Texas 77504
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

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