Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Launched by NOVO NORDISK A/S · Jun 21, 2013
Trial Information
Current as of June 03, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - 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 glucose lowering agent(s) 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 insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 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
Hyattsville, Maryland, United States
La Rochelle Cedex, , France
Rehlingen Siersburg, , Germany
Völklingen, , Germany
Apeldoorn, , Netherlands
Leeuwarden, , Netherlands
Zoetermeer, , Netherlands
Ayr, , United Kingdom
Helsinki, , Finland
Nanterre, , France
Venissieux, , France
Savannah, Georgia, United States
Chattanooga, Tennessee, United States
Plantation, Florida, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Norristown, Pennsylvania, United States
Manati, , Puerto Rico
Corbeil Essonnes, , France
Roma, , Italy
West Seneca, New York, United States
San Diego, California, United States
Cleveland, Ohio, United States
Pavia, , Italy
Amsterdam, , Netherlands
Bologna, , Italy
Milano, , Italy
Dresden, , Germany
Headington, , United Kingdom
Zagreb, , Croatia
Spartanburg, South Carolina, United States
Osijek, , Croatia
Slavonski Brod, , Croatia
St. Gallen, , Switzerland
Palermo, , Italy
Tustin, California, United States
Saint Louis, Missouri, United States
Hohenmölsen, , Germany
Siena, , Italy
Roubaix, , France
Duisburg, , Germany
Delft, , Netherlands
Bradford On Avon, , United Kingdom
Strasbourg, , France
Bath, , United Kingdom
Louisville, Kentucky, United States
Oulu, , Finland
Rotterdam, , Netherlands
Los Angeles, California, United States
Brandon, Florida, United States
Madisonville, Kentucky, United States
Alexandria, Virginia, United States
Austin, Texas, United States
Basel, , Switzerland
Genève 14, , Switzerland
Le Creusot, , France
Caguas, , Puerto Rico
Turku, , Finland
Karlovac, , Croatia
Belgrade, , Serbia
Novi Sad, , Serbia
Bradenton, Florida, United States
Mannheim, , Germany
Hoofddorp, , Netherlands
Jacksonville, Florida, United States
Cincinnati, Ohio, United States
Kerava, , Finland
Kragujevac, , Serbia
Murrells Inlet, South Carolina, United States
Sugar Land, Texas, United States
Greenfield, Indiana, United States
Mine Hill, New Jersey, United States
Muncie, Indiana, United States
Birmingham, Alabama, United States
Whiteville, North Carolina, United States
Hialeah, Florida, United States
Buenos Aires, , Argentina
Oldenburg, , Germany
Phoenix, Arizona, United States
Zollikerberg, , Switzerland
Rotherham, , United Kingdom
Franklin, Indiana, United States
Mesa, Arizona, United States
Luzern 16, , Switzerland
Caba, , Argentina
Miami, Florida, United States
Chicago, Illinois, United States
Miami Lakes, Florida, United States
Venlo, , Netherlands
Houston, Texas, United States
Lomita, California, United States
North Massapequa, New York, United States
Charleston, South Carolina, United States
Glendale, Arizona, United States
Hickory, North Carolina, United States
Northridge, California, United States
Coral Gables, Florida, United States
Portland, Oregon, United States
Kalamazoo, Michigan, United States
Anniston, Alabama, United States
Pell City, Alabama, United States
Burbank, California, United States
Hawaiian Gardens, California, United States
Colorado Springs, Colorado, United States
Las Vegas, Nevada, United States
Akron, Ohio, United States
Delaware, Ohio, United States
Corvallis, Oregon, United States
Lansdale, Pennsylvania, United States
Mount Pleasant, South Carolina, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
Lanus Este, , Argentina
Mar Del Plata, , Argentina
Virovitica, , Croatia
Chalons En Champagne Cedex, , France
Athens, , Greece
Piraeus, , Greece
Thessaloniki, , Greece
Città Di Castello, , Italy
Haxey, , United Kingdom
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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