The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Key facts

Study ID

NCT02098395

Run by

Novo Nordisk A/S

People needed

835

Starts

2014-05-01

Expected to finish

2015-04-01

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Montclair, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — San Ramon, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Golden, Colorado, United States
• Novo Nordisk Investigational Site — Maitland, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Marietta, Georgia, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Champaign, Illinois, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Skokie, Illinois, United States
• Novo Nordisk Investigational Site — Council Bluffs, Iowa, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Chesterfield, Missouri, United States
• Novo Nordisk Investigational Site — Billings, Montana, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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