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
Launched by NOVO NORDISK A/S · Nov 28, 2014
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (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 degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (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 an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia 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) or multiple 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 in Renal Disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) Class IV
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Albuquerque, New Mexico, United States
Anaheim, California, United States
Chicago, Illinois, United States
Topeka, Kansas, United States
Friedrichsthal, , Germany
Hamburg, , Germany
Rehlingen Siersburg, , Germany
Waltham, Massachusetts, United States
Kettering, Ohio, United States
Dayton, Ohio, United States
Manati, , Puerto Rico
Poway, California, United States
West Seneca, New York, United States
Philadelphia, Pennsylvania, United States
Kosice, , Slovakia
Presov, , Slovakia
Münster, , Germany
Skokie, Illinois, United States
Walnut Creek, California, United States
Lexington, Kentucky, United States
Chattanooga, Tennessee, United States
Sulzbach Rosenberg, , Germany
Bratislava, , Slovakia
Fresno, California, United States
Waterbury, Connecticut, United States
Hohenmölsen, , Germany
Jacksonville, Florida, United States
Cincinnati, Ohio, United States
Ann Arbor, Michigan, United States
Kingsport, Tennessee, United States
Northridge, California, United States
Roseville, California, United States
Roswell, Georgia, United States
Dallas, Texas, United States
Hurst, Texas, United States
Rockville, Maryland, United States
Falkensee, , Germany
Metairie, Louisiana, United States
Belgrade, , Serbia
Novi Sad, , Serbia
Bradenton, Florida, United States
Richmond, Virginia, United States
Lucenec, , Slovakia
Paducah, Kentucky, United States
Kragujevac, , Serbia
Council Bluffs, Iowa, United States
Sugar Land, Texas, United States
Kashiwara Shi, Osaka, , Japan
Phoenix, Arizona, United States
Greenfield, Indiana, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Amarillo, Texas, United States
San Antonio, Texas, United States
Port Charlotte, Florida, United States
Essen, , Germany
Saint Ingbert Oberwürzbach, , Germany
Bristol, Tennessee, United States
Stuttgart, , Germany
Overland Park, Kansas, United States
San Ramon, California, United States
Houston, Texas, United States
Lomita, California, United States
Van Nuys, California, United States
Fort Worth, Texas, United States
Kenosha, Wisconsin, United States
Spring Hill, Florida, United States
Kalamazoo, Michigan, United States
Las Vegas, Nevada, United States
Katy, Texas, United States
Ibaraki, , Japan
Miyazaki, , Japan
Osaka, , Japan
Tokyo, , Japan
Levice, , Slovakia
Fleming Island, Florida, United States
Teaneck, New Jersey, United States
Mesquite, Texas, United States
Los Angeles, California, United States
Riverside, California, United States
Tampa, Florida, United States
Gillespie, Illinois, United States
Flint, Michigan, United States
Jackson, Mississippi, United States
Oklahoma City, Oklahoma, United States
Yukon, Oklahoma, United States
Levittown, Pennsylvania, United States
Athens, Tennessee, United States
Bountiful, Utah, United States
Kumamoto Shi, Kumamoto, , Japan
Patients applied
Trial Officials
Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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