Liraglutide in Newly Onset Type 1 Diabetes. (NewLira)

Hvidovre University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Liraglutide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01879917

2012-005317-39 (EudraCT Number)

U1111-1137-3221 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups, including a placebo group

Liraglutide

Active Comparator group

Description:

1.8 mg

Treatment:

Drug: Liraglutide

Saline

Placebo Comparator group

Treatment:

Drug: Placebo