The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes

Sponsor
Tina Vilsboll
Study ID
NCT01795248
Phase
PHASE4
Status
Completed

Conditions

  • Gestational Diabetes Mellitus

Eligibility Criteria

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

Interventions

  • Liraglutide — DRUG
    1.8 mg liraglutide
  • Placebo — DRUG
    Liraglutide without the GLP-1 analogue

Study Details

It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.

Key Dates

Start date
Jul 31, 2012
Status verified
Nov 2020
Primary completion
Sep 30, 2019
Completion
Sep 30, 2020

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Liraglutide
    1.8 mg liraglutide, subcutaneous, once-daily for five years
  • Placebo Comparator: Placebo
    Placebo, subcutaneous, once-daily for one year
  • No Intervention: Control
    Control without previous GDM.

Primary Outcome Measure

Change in glucose tolerance [ Time Frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks ]

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