The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
Information source: University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gestational Diabetes Mellitus
Intervention: Liraglutide (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Tina Vilsboll Official(s) and/or principal investigator(s): Tina Vilsbøll, MD, DMSc, Principal Investigator, Affiliation: University Hospital Gentofte
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.
Clinical Details
Official title: The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Change in glucose tolerance
Secondary outcome: Deterioration in glycaemic status
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- informed oral and written consent
- Previous diagnosis of GDM according to current Danish guidelines (mainly PG
concentrationa t 120 min after 75 g OGTT ≥ 9. 0 mM) during pregnancy within the last 5
years
- Age >18 years
- 25 kg/m2 < BMI < 45 kg/m2
- NGT, IFG and or IGT
- Safe contraception and negative pregnancy test
Exclusion Criteria:
- Patients with diabetes
- HbA1c ≥6. 5%
- Patients with previous pancreatitis or previous neoplasia
- Pregnant or breast feeding women
- Anaemia (haemoglobin <7 mM)
- Women planning to become pregnant within the next 5 years
- Women using other contraception than intrauterine device (IUD) or oral
contraceptives. Women who do not use safe contraception will be offered application
of an IUD.
- Women treated with statins, corticosteroids or other hormone therapy (except
estrogens and gestagens)
- Ongoing abuse of alcohol or narcotics
- Impaired hepatic function (liver transaminases >3 times upper normal limit)
- Impaired renal function (se-creatinine >120 μM and/or albuminuria)
- Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood
pressure >100 mmHg)
- Any condition that the investigator feels would interfere with trial participation
- Receiving any investigational drug within the last 3 months
Locations and Contacts
Diabetology Research Unit, Hellerup 2900, Denmark
Additional Information
Main website for the University Hospital Gentofte
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Starting date: July 2012
Last updated: December 1, 2014
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