Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes

Sponsor
Radboud University Medical Center
Study ID
NCT01392898
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    liraglutide 1.8 mg q.d.
  • Insulin — DRUG
    insulin dosed according titration scheme

Study Details

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy. Large inter-individual differences exist in the level of weight gain after initiation of insulin therapy, but no clear predictive factors have prospectively been identified thus far. Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic control and reduces weight. We hypothesize that in patients who show (excessive) weight gain after introducing insulin therapy, adding liraglutide is effective in reversing body weight while preserving glycaemic control.

Key Dates

First listed
Jul 13, 2011
Start date
Feb 29, 2012
Status verified
Jul 2011
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: liraglutide
  • Active Comparator: insulin

Primary Outcome Measure

Body weight change (measured body weight at 26 weeks minus baseline body weight) [ Time Frame: 26 weeks (26 weeks - baseline) ]

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