Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Sponsor
University of Oulu
Study ID
NCT02611232
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Victoza® — DRUG
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 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 24 months.

Study Details

The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.

Key Dates

Start date
Dec 31, 2015
Status verified
Jan 2022
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Victoza®
    Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
  • Placebo Comparator: Placebo
    Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo

Primary Outcome Measure

FPIR (first phase insulin response) [ Time Frame: From baseline to 26 and 104 weeks ]

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