Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Sponsor
University of Oulu
Study ID
NCT02908087
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Victoza® (liraglutide) — DRUG
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
  • Placebo — DRUG
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Study Details

The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

Key Dates

Start date
Mar 31, 2016
Status verified
Jan 2022
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Victoza® (liraglutide)
    Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®
  • Placebo Comparator: Placebo
    Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo

Primary Outcome Measure

Serum C-peptide AUC [ Time Frame: From baseline to 26 and 52 weeks ]

Related Studies