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

Sponsor
Novo Nordisk A/S
Study ID
NCT01536665
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
  • placebo — DRUG
    Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.

Study Details

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).

Key Dates

Start date
Feb 29, 2012
Status verified
Feb 2017
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Low
  • Experimental: Medium
  • Experimental: High

Primary Outcome Measure

Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) ) [ Time Frame: At week 4 ]

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