Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Launched by NOVO NORDISK A/S · Apr 29, 2014
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female, 18 years or older at the time of signing informed consent
- • Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
- • 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 of childbearing potential 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
- • Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
- • Treatment with any 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 intercurrent illness
- • History of chronic or idiopathic acute pancreatitis
- • Screening calcitonin value greater than or equal to 50 ng/L
- • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
- • Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 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
- • Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
- • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
- • Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
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
Anaheim, California, United States
Inglewood, California, United States
Hyattsville, Maryland, United States
Berlin, New Jersey, United States
Rehlingen Siersburg, , Germany
Bristol, , United Kingdom
Spring Valley, California, United States
Nanterre, , France
Narbonne, , France
Venissieux, , France
Chula Vista, California, United States
Los Angeles, California, United States
Kettering, Ohio, United States
Chattanooga, Tennessee, United States
Olympia, Washington, United States
Renton, Washington, United States
Greensboro, North Carolina, United States
Denver, Colorado, United States
West Seneca, New York, United States
Carmichael, California, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Fargo, North Dakota, United States
New Dehli, New Delhi, India
Oceanside, California, United States
Chicago, Illinois, United States
Las Vegas, Nevada, United States
Amsterdam, , Netherlands
Kosice, , Slovakia
Durban, Kwazulu Natal, South Africa
Nice Cedex 3, , France
Münster, , Germany
Salford, , United Kingdom
Zagreb, , Croatia
Marseille Cédex 05, , France
La Roche Sur Yon Cedex 9, , France
La Mesa, California, United States
Ludwigshafen, , Germany
Walnut Creek, California, United States
Jacksonville, Florida, United States
Marietta, Georgia, United States
Lexington, Kentucky, United States
Butte, Montana, United States
Ljubljana, , Slovenia
Buenos Aires, , Argentina
Johannesburg, Gauteng, South Africa
Neuwied, , Germany
Cluj Napoca, Cluj, Romania
Moldava Nad Bodvou, , Slovakia
Plymouth, , United Kingdom
San Mateo, California, United States
Tustin, California, United States
Colorado Springs, Colorado, United States
San Antonio, Texas, United States
Pointe à Pitre, , France
Wangen, , Germany
Long Beach, California, United States
Flint, Michigan, United States
Troy, Michigan, United States
Wilmington, North Carolina, United States
Ozark, Alabama, United States
Roseville, California, United States
Roswell, Georgia, United States
Canal Fulton, Ohio, United States
Altoona, Pennsylvania, United States
Beaver, Pennsylvania, United States
Dallas, Texas, United States
Saint George, Utah, United States
Hurst, Texas, United States
Ahmedabad, Gujarat, India
Indore, Madhya Pradesh, India
Gurnee, Illinois, United States
Madisonville, Kentucky, United States
Ponce, , Puerto Rico
Lampertheim, , Germany
Koper, , Slovenia
Novo Mesto, , Slovenia
Le Creusot, , France
Sidcup, , United Kingdom
Paris, , France
Bucharest, , Romania
Statesville, North Carolina, United States
Hull, , United Kingdom
Metairie, Louisiana, United States
Karlovac, , Croatia
Oradea, Bihor, Romania
Plano, Texas, United States
Marseille Cedex 08, , France
Hoofddorp, , Netherlands
Winter Haven, Florida, United States
Buckley, Michigan, United States
Toms River, New Jersey, United States
Salt Lake City, Utah, United States
Morehead City, North Carolina, United States
Rapid City, South Dakota, United States
Paducah, Kentucky, United States
Irving, Texas, United States
Ipswich, , United Kingdom
Kissimmee, Florida, United States
Saint Herblain, , France
Bangalore, Karnataka, India
Miami, Florida, United States
Council Bluffs, Iowa, United States
Albuquerque, New Mexico, United States
Murrells Inlet, South Carolina, United States
Mumbai, Maharashtra, India
Gilbert, Arizona, United States
Phoenix, Arizona, United States
San Diego, California, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
Amarillo, Texas, United States
Birmingham, Alabama, United States
Hialeah, Florida, United States
New Windsor, New York, United States
Natchitoches, Louisiana, United States
Cincinnati, Ohio, United States
Longview, Texas, United States
Saint Ingbert Oberwürzbach, , Germany
Aguascalientes, , Mexico
Winchester, Virginia, United States
Godoy Cruz, , Argentina
Arlington, Virginia, United States
Wenatchee, Washington, United States
Pierre Bénite, , France
Stuttgart, , Germany
Meridian, Idaho, United States
Mason, Ohio, United States
Maumee, Ohio, United States
Capital Federal, , Argentina
Northwood, , United Kingdom
Rostock, , Germany
Soham, , United Kingdom
Skopje, , North Macedonia
New Delhi, , India
Strasbourg, , France
Miami Lakes, Florida, United States
Lake Charles, Louisiana, United States
Kenosha, Wisconsin, United States
Spring Hill, Florida, United States
Saint Louis, Missouri, United States
Mysore, Karnataka, India
México D.F., México, D.F., Mexico
Cooper City, Florida, United States
Peoria, Illinois, United States
Carlisle, Ohio, United States
Gaffney, South Carolina, United States
Cakovec, , Croatia
Brooklyn, New York, United States
Guadalajara, Jalisco, Mexico
Corvallis, Oregon, United States
Lansdale, Pennsylvania, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Rotterdam, , Netherlands
Haxey, , United Kingdom
Johns Creek, Georgia, United States
Jersey Shore, Pennsylvania, United States
Sherman Oaks, California, United States
Humble, Texas, United States
Chennai, Tamil Nadu, India
Distrito Federal, México, D.F., Mexico
Basingstoke, , United Kingdom
Taunton, , United Kingdom
Tuscumbia, Alabama, United States
Rialto, California, United States
Morganton, North Carolina, United States
Marshall, Texas, United States
Swansea, , United Kingdom
Trinité La Martinique, , France
Elk Grove, California, United States
Orange, California, United States
Pomona, California, United States
Rolling Hills Estates, California, United States
Clearwater, Florida, United States
Lakeland, Florida, United States
Winter Park, Florida, United States
Conyers, Georgia, United States
Norcross, Georgia, United States
Park City, Kansas, United States
Shreveport, Louisiana, United States
Sterling Heights, Michigan, United States
Trenton, New Jersey, United States
Shelby, North Carolina, United States
Toledo, Ohio, United States
Clairton, Pennsylvania, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Caba, , Argentina
Krapinske Toplice, , Croatia
Bobigny, , France
Bois Guillaume, , France
Bourgoin Jallieu, , France
Rang Du Fliers, , France
Saint Nazaire, , France
Berlin, , Germany
Essen, , Germany
Jerichow, , Germany
Kolkata, West Bengal, India
Tetovo, , North Macedonia
Pitesti, Arges, Romania
Iasi, , Romania
Piestany, , Slovakia
Puchov, , Slovakia
Trencin, , Slovakia
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Harrogate, North Yorkshire, , United Kingdom
México D.F., , Mexico
Distrito Federal, , Mexico
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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