The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 1
Intervention: liraglutide (Drug); placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Lene Jensen, Study Director, Affiliation: Novo Nordisk A/S
Summary
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide
adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects
with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment
with liraglutide or placebo.
Subjects will initially be randomised to one of the three dose groups, and subsequently
randomly allocated to one of two treatment sequences (liraglutide/placebo or
placebo/liraglutide).
Clinical Details
Official title: The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L))
Secondary outcome: Geometric mean glucagon concentration at plasma glucose levels other than nadirGeometric mean concentrations of adrenaline and noradrenaline at nadir Time from termination of insulin infusion at nadir to reach plasma glucose 4.0
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to
randomisation
- Body mass index (BMI) between 20. 0 and 28. 0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Use of liraglutide or exenatide within 3 months of randomisation
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the trial physician or
hospitalisation for diabetic ketoacidosis during the previous 6 months
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
Locations and Contacts
Graz 8036, Austria
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2012
Last updated: August 21, 2012
|