The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
This trial is active, not recruiting.
|Condition||gestational diabetes mellitus|
|Collaborator||Novo Nordisk A/S|
|Start date||July 2012|
|End date||August 2019|
|Trial size||100 participants|
|Trial identifier||NCT01795248, 2012-001371-37, GDM-TREAT|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
1.8 mg liraglutide, subcutaneous, once-daily for five years
Placebo, subcutaneous, once-daily for one year
Change in glucose tolerance
time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks
Deterioration in glycaemic status
time frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks
Female participants at least 18 years old.
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
|Official title||The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus|
|Principal investigator||Tina Vilsbøll, MD, DMSc|
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