Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

Sponsor
Turku University Hospital
Study ID
NCT04324229
Status
Active Not Recruiting

Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Liraglutide 6 MG/ML [Victoza] — DRUG
    Starting dose of liraglutide 0.6 mg will be administered for one week, after which dose will be escalated to liraglutide 1.2 mg for one week and thereafter liraglutide 1.8 mg s.c. daily injections.
  • Placebos — DRUG
    Starting dose of placebo 0.1 ml will be administered for one week, after which dose will be escalated to placebo 0.2 ml for one week and thereafter placebo 0.3 ml s.c. daily injections.

Study Details

Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery. Aim of the study is to investigate if 12 months' liraglutide treatment could decrease the risk of T2D in obese women who have had gestational diabetes. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group, once daily. Same laboratory tests are taken and instructions given at baseline 6 month and one year. After one year visits once a year until 5 years with same laboratory tests and measurements are taken.

Key Dates

Start date
Feb 7, 2020
Status verified
Dec 2023
Primary completion
Sep 30, 2024
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: liraglutide
  • Placebo Comparator: placebo

Primary Outcome Measure

Incidence of type 2 diabetes [ Time Frame: from year 1 to 5 ]

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