Liraglutide in Newly Onset Type 1 Diabetes.

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Bispebjerg Hospital; Hillerod Hospital, Denmark; Hospital of South West Denmark; Odense University Hospital; Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0

• Age 18 - 40 years - both inclusive

• Postprandial C-peptide > 0.2 nmol/l following sustacal meal test

• Able to understand the written patient information and to give informed consent

Exclusion Criteria:

• Type 2 diabetes

• Body mass index <20 kg/m2

• Pregnancy or unwillingness to use safe contraceptives

• Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0

• Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0