Title
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
Phase
Phase 4Lead Sponsor
University Hospital, Gentofte, CopenhagenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Gestational Diabetes MellitusIntervention/Treatment
liraglutide ...Study Participants
105It 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.
1.8 mg liraglutide
Liraglutide without the GLP-1 analogue
1.8 mg liraglutide, subcutaneous, once-daily for five years
Control without previous GDM.
Inclusion Criteria for women with previous GDM: 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 for women with previous GDM: 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 Inclusion criteria for women without previous GDM: Informed oral and written consent Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT Safe contraception and negative pregnancy test Pregnancy within the last ten years without GDM Exclusion Criteria for women without previous GDM : Pregnant or breast feeding women Anaemia (haemoglobin <7 mM) Inclusion Criteria for women without previous GDM and without NAFLD: Informed oral and written consent Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT At least one pregnancy witin the last ten years without GDM Exclusion Criteria for women without previous GDM and without NAFLD: Pregnant or breast feeding women Anaemia (haemoglobin <7 mM) Steatosis as assessed by ultrasound scanning Recieving any investigational drug within the last 3 months Any condition that the investigator feels would interfere with the trial participation Inclusion Criteria for women with biopsi-verified NAFLD: Informed oral and written consent Women with known NAFLD or NASH Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT At least one prior pregnancy Exclusion Criteria for women with biopsi-verified NAFLD: women with established cirrhosis Pregnant or breast feedning women Anaemia (haemoglobin <7 mM) Women treated with statins, corticosteroids or other hormone therapy ( except oestrogens and gestagens) Ongoing abuse of alcohol or narcotics Impaired renal function (se-creatinine > 120 μM and/or albuminuria) Uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood presure > 100 mmHg) Any condition that the investigator feels would interfere with trial participation
