Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Last updated: July 11, 2022
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Foot Ulcers

Diabetic Gastroparesis

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT02906930
NN9924-4233
2015-005622-19
U1111-1177-5112
JapicCTI-163384
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age above or equal to 18 years at the time of signing informed consent.For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening - HbA1c (glycosylated haemoglobin) between 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Treatment with diet and exercise for at least 30 days prior to day of screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.For Czech Republic only: Adequate contraceptive measures are always one highly reliable method (such as intrauterine device, sterilisation of one of the partners, hormonal birth control methods) plus one supplementary barrier method (such as condom, diaphragm) with a spermicide. In justified cases, this combination may be replaced with a double-barrier method with a spermicide. Total sexual abstinence may also be considered contraception. (Please note: hormonal contraception should always be discussed with a gynaecologist) - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation - Subjects presently classified as being in New York Heart Association Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Subjects with alanine aminotransferase above 2.5 x upper normal limit - Renal impairment defined as estimated glomerular filtration rate below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula - Treatment with any medication for the indication of diabetes or obesity in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)

Study Design

Total Participants: 703
Study Start date:
September 20, 2016
Estimated Completion Date:
December 08, 2017

Connect with a study center

  • Novo Nordisk Investigational Site

    Algiers, 16003
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Broumov, 550 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Chrudim, 537 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Mlada Boleslav, 293 50
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Olomouc, 77900
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Prague 1, 11694
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Como, 22042
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Palermo, 90129
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Pisa, 56124
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00168
    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

    Chuo-ku Tokyo, 103-0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0027
    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

    Yokohama, Kanagawa, 236-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama-shi, Kanagawa, 236-0004
    Japan

    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

    Targoviste, Dambovita 130095
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Ploiesti, Prahova 100018
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Bucharest, 011234
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Dzerzhinskiy, 140091
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420073
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 194358
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Yoshkar-Ola, 424004
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Adana, 01250
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34718
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Lancaster, California 93534
    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

    North Hollywood, California 91606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Riverside, California 92506
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Jose, California 95148
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Mateo, California 94401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toluca, California 91606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Doral, Florida 33166
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33186
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Harbor, Florida 34684-3609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33026
    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 33607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Woodstock, Georgia 30189-4255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nampa, Idaho 83686-6011
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Metairie, Louisiana 70002
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, Michigan 48307
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Elkhorn, Nebraska 68022
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheboro, North Carolina 27203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45255
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Willoughby Hills, Ohio 44094
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19140
    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

    Houston, Texas 77058
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mesquite, Texas 75149
    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

    Waco, Texas 76710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23510-2015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salem, Virginia 24153-6404
    United States

    Site Not Available

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