Liraglutide in Newly Onset Type 1 Diabetes.
- Registration Number
- NCT01879917
- Lead Sponsor
- Hvidovre University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Placebo - Liraglutide Liraglutide 1.8 mg
- Primary Outcome Measures
Name Time Method Beta-cell function 52 weeks 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.
- Secondary Outcome Measures
Name Time Method Postprandial glucagon 52 weeks 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.
Trial Locations
- Locations (1)
Dep. of Endocrinology, Hvidovre University Hospital
🇩🇰Hvidovre, Capital, Denmark