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

Tina Vilsboll

Status and phase: Completed; Phase 4

Conditions: Gestational Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Liraglutide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01795248

GDM-TREAT

2012-001371-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

Liraglutide

Experimental group

Description:

1.8 mg liraglutide, subcutaneous, once-daily for five years

Treatment:

Drug: Liraglutide

Placebo

Placebo Comparator group

Description:

Placebo, subcutaneous, once-daily for one year

Treatment:

Drug: Placebo

Control

No Intervention group

Description:

Control without previous GDM.