Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

Sponsor
Per-Ola Carlsson
Study ID
NCT02617654
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells. The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.

Key Dates

Start date
Nov 30, 2015
Status verified
Nov 2020
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

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

Arms

  • Active Comparator: Liraglutide treatment
    Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks
  • Placebo Comparator: Placebo treatment
    Treatment with placebo once daily for 52 weeks

Primary Outcome Measure

The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production [ Time Frame: 52 weeks ]

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