The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536665

NN9211-3953

U1111-1123-9882 (Other Identifier)

2011-004240-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Low

Experimental group

Treatment:

Drug: liraglutide

Drug: placebo

Medium

Experimental group

Treatment:

Drug: liraglutide

Drug: placebo

High

Experimental group

Treatment:

Drug: liraglutide

Drug: placebo