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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01536665
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low	liraglutide	-
Low	placebo	-
Medium	placebo	-
High	placebo	-
Medium	liraglutide	-
High	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )	At week 4

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentrations of adrenaline and noradrenaline at nadir	At week 4
Time from termination of insulin infusion at nadir to reach plasma glucose 4.0	At week 4
Geometric mean glucagon concentration at plasma glucose levels other than nadir	At week 4

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria