The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Launched by NOVO NORDISK A/S · Mar 25, 2014
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- • Male or female, aged equal to or greater than 18 years at the time of signing informed consent
- • Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
- • Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
- • Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
- • HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
- Exclusion Criteria:
- • Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
- • Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed
- • Known proliferative retinopathy or maculopathy requiring acute treatment
- • Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
- • Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
- • History of acute or chronic pancreatitis
- • Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
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
Minneapolis, Minnesota, United States
Atlanta, Georgia, United States
Helsinki, , Finland
Pori, , Finland
La Rochelle Cedex, , France
Toulouse Cedex, , France
Apeldoorn, , Netherlands
Stockholm, , Sweden
Umeå, , Sweden
örebro, , Sweden
Oulu, , Finland
Montpellier Cedex 5, , France
ängelholm, , Sweden
Renton, Washington, United States
Chesterfield, Missouri, United States
Dallas, Texas, United States
Concord, California, United States
Hvidovre, , Denmark
København, , Denmark
Gijón, , Spain
Aurora, Colorado, United States
Laval, Quebec, Canada
Aalst, , Belgium
Chicago, Illinois, United States
Graz, , Austria
Utrecht, , Netherlands
århus C, , Denmark
Bonheiden, , Belgium
Sofia, , Bulgaria
Odense, , Denmark
Firenze, , Italy
Roma, , Italy
Plovdiv, , Bulgaria
Bruxelles, , Belgium
Leuven, , Belgium
Cape Town, Western Cape, South Africa
Skokie, Illinois, United States
Brussels, , Belgium
Edegem, , Belgium
Escondido, California, United States
Walnut Creek, California, United States
Marietta, Georgia, United States
Lexington, Kentucky, United States
Butte, Montana, United States
Albany, New York, United States
Staten Island, New York, United States
Chattanooga, Tennessee, United States
Malmö, , Sweden
Palermo, , Italy
Almería, , Spain
Fresno, California, United States
San Mateo, California, United States
Catanzaro, , Italy
Wien, , Austria
Bergamo, , Italy
Siena, , Italy
Eindhoven, , Netherlands
Turku, , Finland
Den Haag, , Netherlands
Wilmington, North Carolina, United States
Roswell, Georgia, United States
Las Vegas, Nevada, United States
Billings, Montana, United States
Halifax, Nova Scotia, Canada
Sherbrooke, Quebec, Canada
Rockville, Maryland, United States
Chapel Hill, North Carolina, United States
Le Creusot, , France
Paris, , France
Sevilla, , Spain
Golden, Colorado, United States
Maitland, Florida, United States
Montclair, California, United States
Round Rock, Texas, United States
Mississauga, Ontario, Canada
Marseille Cedex 08, , France
Morehead City, North Carolina, United States
Ventura, California, United States
Council Bluffs, Iowa, United States
Cornwall, Ontario, Canada
Hamilton, Ontario, Canada
Amarillo, Texas, United States
Johannesburg, Gauteng, South Africa
Thornhill, Ontario, Canada
Little Rock, Arkansas, United States
Bristol, Tennessee, United States
Boussu, , Belgium
Pierre Bénite, , France
Den Bosch, , Netherlands
Strasbourg, , France
Jyväskylä, , Finland
San Ramon, California, United States
Kortrijk, , Belgium
Calgary, Alberta, Canada
Murray, Utah, United States
Bennington, Vermont, United States
Federal Way, Washington, United States
Ogden, Utah, United States
Linköping, , Sweden
Champaign, Illinois, United States
Sesto San Giovanni (Mi), , Italy
Austin, Texas, United States
Phoenix, Arizona, United States
Jamaica, New York, United States
Fargo, North Dakota, United States
Seattle, Washington, United States
Mouscron, , Belgium
Sint Niklaas, , Belgium
Blagoevgrad, , Bulgaria
Pazardzhik, , Bulgaria
Razgrad, , Bulgaria
Montreal, Quebec, Canada
Joensuu, , Finland
Reims, , France
Trinité La Martinique, , France
Amersfoort, , Netherlands
Segovia, , Spain
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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