Liraglutide in Newly Onset Type 1 Diabetes.

Hvidovre University Hospital65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

LiraglutideDRUG

PlaceboDRUG

Saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Dep. of Endocrinology, Hvidovre University Hospital

Hvidovre, Capital, Denmark

Outcomes

Primary Outcomes

Beta-cell function

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.

Time frame: 52 weeks

Secondary Outcomes

Postprandial glucagon

To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test.

Time frame: 52 weeks

Data from ClinicalTrials.gov

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