Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes
Launched by NOVO NORDISK A/S · Apr 14, 2011
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects with type 2 diabetes
- • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
- • Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
- • Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening
- • Body Mass Index (BMI) maximum 40 kg/m\^2
- Exclusion Criteria:
- • Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
- • Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
- • Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
- • Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
- • Screening calcitonin at least 50 ng/L
- • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
- • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
- • Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
- • Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
- • History of chronic pancreatitis or idiopathic acute pancreatitis
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
Santa Barbara, California, United States
Greer, South Carolina, United States
Anaheim, California, United States
La Jolla, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Hyattsville, Maryland, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Hamburg, , Germany
Herrenberg, , Germany
Rehlingen Siersburg, , Germany
Dundee, , United Kingdom
Orlando, Florida, United States
Newport News, Virginia, United States
Greenville, North Carolina, United States
Kettering, Ohio, United States
Chattanooga, Tennessee, United States
Ogden, Utah, United States
Milwaukee, Wisconsin, United States
Orange, California, United States
Chesterfield, Missouri, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Norristown, Pennsylvania, United States
Dallas, Texas, United States
Oklahoma City, Oklahoma, United States
Concord, California, United States
Poway, California, United States
Torino, , Italy
Granada, , Spain
Valencia, , Spain
Delray Beach, Florida, United States
Las Vegas, Nevada, United States
West Seneca, New York, United States
Asheville, North Carolina, United States
Canton, Ohio, United States
Laval, Quebec, Canada
Moscow, , Russian Federation
Winston Salem, North Carolina, United States
Taoyuan, , Taiwan
Kansas City, Missouri, United States
Edmonton, Alberta, Canada
Taipei, , Taiwan
Bangkok, , Thailand
Bronx, New York, United States
Durban, Kwazulu Natal, South Africa
Münster, , Germany
Pohlheim, , Germany
Debrecen, , Hungary
Dublin, , Ireland
Headington, , United Kingdom
Stevenage, , United Kingdom
Melbourne, Victoria, Australia
Hyderabad, , India
Cheras, , Malaysia
Kota Bharu, Kelantan, , Malaysia
Oulu, , Finland
Greenbrae, California, United States
Bad Neuenahr Ahrweiler, , Germany
Walnut Creek, California, United States
Lexington, Kentucky, United States
Albany, New York, United States
Northport, New York, United States
Charlotte, North Carolina, United States
East Providence, Rhode Island, United States
Spartanburg, South Carolina, United States
Monterrey, Nuevo León, Mexico
Pulau Pinang, , Malaysia
Broadmeadow, New South Wales, Australia
Penrith, New South Wales, Australia
East Ringwood, Victoria, Australia
Gyula, , Hungary
Kochi, Kerala, India
Palermo, , Italy
Moldava Nad Bodvou, , Slovakia
Almería, , Spain
La Coruña, , Spain
Encino, California, United States
San Mateo, California, United States
Tustin, California, United States
Waterbury, Connecticut, United States
Spokane, Washington, United States
Winnipeg, Manitoba, Canada
Hohenmölsen, , Germany
Taichung City, , Taiwan
Edgbaston, Birmingham, , United Kingdom
Pune, Maharashtra, India
Patna, , India
Siena, , Italy
Llantrisant, , United Kingdom
Partida De Bacarot, , Spain
Long Beach, California, United States
Clearwater, Florida, United States
Tampa, Florida, United States
Troy, Michigan, United States
Kingsport, Tennessee, United States
San Juan, , Puerto Rico
Bermuda Dunes, California, United States
Roswell, Georgia, United States
Avon, Illinois, United States
Cincinnati, Ohio, United States
Beaver, Pennsylvania, United States
Saint George, Utah, United States
Ahmedabad, Gujarat, India
Bloemfontein, Free State, South Africa
Brits, North West, South Africa
Indore, Madhya Pradesh, India
Camperdown, New South Wales, Australia
Port Elizabeth, Eastern Cape, South Africa
Budapest, , Hungary
Gurnee, Illinois, United States
Michigan City, Indiana, United States
Rockville, Maryland, United States
Eger, , Hungary
London, , United Kingdom
Chapel Hill, North Carolina, United States
Frankfurt, , Germany
Keswick, South Australia, Australia
Simpsonville, South Carolina, United States
Cochin, Kerala, India
Bhubaneswar, Orissa, India
Jaipur, Rajasthan, India
Chennai, Tamil Nadu, India
Kolkata, , India
Shelby, North Carolina, United States
Statesville, North Carolina, United States
Taylors, South Carolina, United States
Imatra, , Finland
Denver, Colorado, United States
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Olbia, , Italy
Nove Zamky, , Slovakia
Glasgow, , United Kingdom
Letchworth, , United Kingdom
Golden, Colorado, United States
Virginia Beach, Virginia, United States
Montclair, California, United States
Hamilton, Ontario, Canada
Pécs, , Hungary
Newark, New Jersey, United States
Saint Petersburg, , Russian Federation
Mississauga, Ontario, Canada
Eisenach, , Germany
Esslingen, , Germany
Grevenbroich, , Germany
Cosenza, , Italy
Monserrato, Cagliari, , Italy
Belfast, , United Kingdom
Jacksonville, Florida, United States
Buckley, Michigan, United States
Nampa, Idaho, United States
Metairie, Louisiana, United States
North East, Maryland, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Lucenec, , Slovakia
Valencia, California, United States
Lawrenceville, Georgia, United States
Henderson, Nevada, United States
Morehead City, North Carolina, United States
San Antonio, Texas, United States
Coffs Harbour, New South Wales, Australia
Kursk, , Russian Federation
Penza, , Russian Federation
Saratov, , Russian Federation
Pittsburgh, Pennsylvania, United States
Lubbock, Texas, United States
Asheboro, North Carolina, United States
Irving, Texas, United States
Rehburg Loccum, , Germany
Sevilla, , Spain
Hanko, , Finland
Penang, , Malaysia
Putrajaya, , Malaysia
Bangalore, Karnataka, India
Trivandrum, Kerala, India
Chiang Mai, , Thailand
Kissimmee, Florida, United States
Pembroke Pines, Florida, United States
Nashua, New Hampshire, United States
Thiruvanathapuram, Kerala, India
Miami, Florida, United States
Trichy, Tamil Nadu, India
Stavropol, , Russian Federation
Valladolid, , Spain
Sugar Land, Texas, United States
Mumbai, Maharashtra, India
Bangkoknoi, Bangkok, , Thailand
Seremban, , Malaysia
Tainan City, , Taiwan
Johannesburg, Gauteng, South Africa
Vaderbijlpark, Gauteng, South Africa
San Diego, California, United States
Desoto, Texas, United States
Cornwall, Ontario, Canada
Voronezh, , Russian Federation
Wrexham, , United Kingdom
Columbus, Georgia, United States
Fishers, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Forlì, , Italy
Carmarthen, , United Kingdom
Birmingham, Alabama, United States
Monterey, California, United States
Conyers, Georgia, United States
Crestview Hills, Kentucky, United States
Chilliwack, British Columbia, Canada
Szeged, , Hungary
Flemington, New Jersey, United States
Hialeah, Florida, United States
Fort Lauderdale, Florida, United States
Burlington, North Carolina, United States
Meadowbrook, Queensland, Australia
Oldenburg, , Germany
Guadalajara, Jalisco, Mexico
St Helens, , United Kingdom
Galway, , Ireland
Southfield, Michigan, United States
Stuttgart, , Germany
Killeen, Texas, United States
Los Angeles, California, United States
Fair Oaks, California, United States
Fresno, California, United States
Colorado Springs, Colorado, United States
Melbourne, Florida, United States
Decatur, Georgia, United States
Woodstock, Georgia, United States
Meridian, Idaho, United States
O'fallon, Illinois, United States
Franklin, Indiana, United States
Saint Charles, Missouri, United States
Toms River, New Jersey, United States
Cleveland, Ohio, United States
Mason, Ohio, United States
Maumee, Ohio, United States
Bridgeville, Pennsylvania, United States
Columbia, South Carolina, United States
Pelzer, South Carolina, United States
Burke, Virginia, United States
Manassas, Virginia, United States
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Drummondville, Quebec, Canada
Quebec, , Canada
Helsinki, , Finland
Kokkola, , Finland
Gurgaon, Haryana, India
Kolkatta, West Bengal, India
Novara, , Italy
Vsevolozhsk, , Russian Federation
Singapore, , Singapore
Bratislava, , Slovakia
Umkomaas, Kwazulu Natal, South Africa
Cape Town, Western Cape, South Africa
Bury St Edmunds, , United Kingdom
Fife, , United Kingdom
Gloucester, , United Kingdom
Lancaster, , United Kingdom
Weston Super Mare, , 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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