Status:
COMPLETED
Liraglutide in Newly Onset Type 1 Diabetes.
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Hillerod Hospital, Denmark
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
PHASE3
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 typ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01879917
Start Date
February 1 2014
End Date
August 1 2018
Last Update
March 30 2021
Active Locations (1)
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1
Dep. of Endocrinology, Hvidovre University Hospital
Hvidovre, Capital, Denmark, 2650