A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Launched by NOVO NORDISK A/S · Jul 15, 2015
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female, age greater than or equal to 18 years at the time of signing informed consent
- • Subjects diagnosed with type 2 diabetes mellitus
- • HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
- • Body mass index greater than or equal to 20 kg/m\^2
- • Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
- • Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
- Exclusion Criteria:
- • Screening calcitonin greater than or equal to 50 ng/L
- • Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
- • Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
- • Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
- • History of pancreatitis (acute or chronic)
- • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
- • Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
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
Greer, South Carolina, United States
Hyattsville, Maryland, United States
Spring Valley, California, United States
Waltham, Massachusetts, United States
Haifa, , Israel
Tel Hashomer, , Israel
Pavia, , Italy
Bologna, , Italy
Durban, Kwazulu Natal, South Africa
Zabrze, , Poland
Torquay, , United Kingdom
Coventry, , United Kingdom
Walnut Creek, California, United States
Cuernavaca, Morelos, Mexico
Buenos Aires, , Argentina
Mendoza, , Argentina
Gdansk, , Poland
Verona, , Italy
Hamar, , Norway
Moscow, , Russian Federation
Fresno, California, United States
Porto Alegre, , Brazil
Catanzaro, , Italy
Bermuda Dunes, California, United States
Sacramento, California, United States
Beaver, Pennsylvania, United States
Billings, Montana, United States
Pecs, , Hungary
Bialystok, , Poland
Brits, North West, South Africa
Kolkata, West Bengal, India
Novosibirsk, , Russian Federation
Ankara, , Turkey
Rockville, Maryland, United States
Wolverhampton, , United Kingdom
Johannesburg, Gauteng, South Africa
Jaipur, Rajasthan, India
Hull, , United Kingdom
Metairie, Louisiana, United States
Buckley, Michigan, United States
Lancaster, California, United States
San Antonio, Texas, United States
Rishon Le Zion, , Israel
Penza, , Russian Federation
Ventura, California, United States
Boynton Beach, Florida, United States
Humboldt, Tennessee, United States
Irving, Texas, United States
Durango, , Mexico
Stavanger, , Norway
Nashua, New Hampshire, United States
Miami, Florida, United States
Istanbul, , Turkey
Pretoria, Gauteng, South Africa
Phoenix, Arizona, United States
Alberton, , South Africa
Avon, Indiana, United States
Indianapolis, Indiana, United States
Monterey, California, United States
New Windsor, New York, United States
São Paulo, Sao Paulo, Brazil
Guadalajara, Jalisco, Mexico
Saint Petersburg, , Russian Federation
Samsun, , Turkey
Oslo, , Norway
Colorado Springs, Colorado, United States
Mason, Ohio, United States
Maumee, Ohio, United States
Umkomaas, Kwazulu Natal, South Africa
Capital Federal, , Argentina
Coimbatore, Tamil Nadu, India
Caba, , Argentina
Visakhapatnam, Andhra Pradesh, India
Bangalore, Karnataka, India
Pune, Maharashtra, India
Dallas, Texas, United States
Midlothian, Virginia, United States
Rohtak, Haryana, India
Delhi, New Delhi, India
Cape Town, Western Cape, South Africa
Nahariya, , Israel
Ciudad Madero, Tamaulipas, Mexico
Kenosha, Wisconsin, United States
Glendale, Arizona, United States
Mumbai, Maharashtra, India
Stavropol, , Russian Federation
Trnava, , Slovakia
Albuquerque, New Mexico, United States
Kaposvár, , Hungary
Zerifin, , Israel
Houston, Texas, United States
Katy, Texas, United States
Blackfoot, Idaho, United States
Tel Aviv, , Israel
Kløfta, , Norway
Rize, , Turkey
St. Petersburg, , Russian Federation
Prievidza, , Slovakia
Cittadella (Pd), , Italy
Palermo, , Italy
Tuscumbia, Alabama, United States
Praha 4, , Czechia
Sabinov, , Slovakia
Muscle Shoals, Alabama, United States
Lake Worth, Florida, United States
Plzen, , Czechia
Prague 1, , Czechia
Budapest, , Hungary
Dunaujvaros, , Hungary
Secunderabad, Andhra Pradesh, India
Nagpur, Maharashtra, India
Tel Aviv, , Israel
Negrar (Vr), , Italy
Bodø, , Norway
Hoenefoss, , Norway
Lierskogen, , Norway
Tananger, , Norway
Trebisov, , Slovakia
Trencin, , Slovakia
Cosmo City, Gauteng, South Africa
Bursa, , Turkey
Angus, , United Kingdom
Dudley, , United Kingdom
Dundee, , United Kingdom
Fife, , United Kingdom
Rotherham, , 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
Similar Trials