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

NCT02617654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Liraglutide

Treatment with liraglutide for 52 weeks

DRUG

Placebo for liraglutide

Placebo for liraglutide. Treatment once daily for 52 weeks

Sponsors & Collaborators

  • Per-Ola Carlsson

    lead OTHER

Principal Investigators

  • Per-Ola Carlsson, MD, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617654 on ClinicalTrials.gov