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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01536665

Enrollment

Registered

2012-02-22

Start date

2012-02-29

Completion date

2012-08-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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).

Interventions

DRUGliraglutide

Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

DRUGplacebo

Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Geometric mean concentrations of adrenaline and noradrenaline at nadir	At week 4

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026