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

Phase 4
Completed
Conditions
Gestational Diabetes Mellitus
Interventions
Drug: Placebo
Registration Number
NCT01795248
Lead Sponsor
Tina Vilsboll
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
105
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo, subcutaneous, once-daily for one year
LiraglutideLiraglutide1.8 mg liraglutide, subcutaneous, once-daily for five years
Primary Outcome Measures
NameTimeMethod
Change in glucose tolerancefrom baseline to 52 wks, 53 wks, 260 wks, and 261 wks

Changes in glucose is measured by area under the curve for the plasma glucose excursion following a 4-hour 75 g oral glucose tolerance test (OGTT)

Secondary Outcome Measures
NameTimeMethod
Deterioration in glycaemic statusfrom baseline to 52 wks, 53, wks, 260 wks, and 261 wks

Percentage of subjects in each treatment arm with normal glucose tolerance (NGT) at inclusion who develop impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) or type 2 diabetes; or with IFG or IGT who develop combined IFG/IGT; or with combined IFG/IGT who develop type 2 diabetes

Trial Locations

Locations (1)

Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

🇩🇰

Hellerup, Denmark

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