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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


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 nadir

Geometric mean concentrations of adrenaline and noradrenaline at nadir

Time from termination of insulin infusion at nadir to reach plasma glucose 4.0


Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.


Inclusion Criteria:

- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to


- 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

Page last updated: August 23, 2015

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