Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Launched by NOVO NORDISK A/S · Feb 3, 2014
Trial Information
Current as of April 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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
Trial Officials
Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S
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
Wichita, Kansas, United States
Los Angeles, California, United States
Savannah, Georgia, United States
Dallas, Texas, United States
Roma, , Italy
Terni, , Italy
Galati, , Romania
Charlotte, North Carolina, United States
Spartanburg, South Carolina, United States
Catania, , Italy
Siena, , Italy
Billings, Montana, United States
Bloemfontein, Free State, South Africa
Novosibirsk, , Russian Federation
Port Elizabeth, Eastern Cape, South Africa
Johannesburg, Gauteng, South Africa
Toronto, Ontario, Canada
Oradea, Bihor, Romania
Montclair, California, United States
Trois Rivières, Quebec, Canada
Arkhangelsk, , Russian Federation
Durban, Kwazulu Natal, South Africa
Buzau, , Romania
Saratov, , Russian Federation
Boynton Beach, Florida, United States
Cincinnati, Ohio, United States
Sugar Land, Texas, United States
London, Ontario, Canada
Birmingham, Alabama, United States
Whiteville, North Carolina, United States
Aguascalientes, , Mexico
St Helens, , United Kingdom
Saint Petersburg, , Russian Federation
Pisa, , Italy
Franklin, Indiana, United States
Umkomaas, Kwazulu Natal, South Africa
Miami Lakes, Florida, United States
Lomita, California, United States
Montreal, Quebec, Canada
Ciudad Madero, Tamaulipas, Mexico
Saint Petesburg, , Russian Federation
Stavropol, , Russian Federation
Northridge, California, United States
Miami, Florida, United States
Kazan, , Russian Federation
Omaha, Nebraska, United States
Suita Shi, Osaka, , Japan
Anniston, Alabama, United States
Pell City, Alabama, United States
Hawaiian Gardens, California, United States
Delaware, Ohio, United States
Tokyo, , Japan
Monterrey, Nuevo León, Mexico
Krugersdorp, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Brownsburg, Indiana, United States
Olive Branch, Mississippi, United States
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
Sealy, Texas, United States
Colorado Springs, Colorado, United States
Lexington, Kentucky, United States
Belvidere, New Jersey, United States
Levittown, Pennsylvania, United States
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Pointe Claire, Quebec, Canada
Rome, , Italy
Kyoto Shi, Kyoto, , Japan
Bucharest, , Romania
Chelyabinsk, , Russian Federation
Sophiatown, Gauteng, South Africa
Cardiff, , United Kingdom
Dundee, , United Kingdom
Swansea, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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