This trial is active, not recruiting.

Condition gestational diabetes mellitus
Treatments liraglutide, placebo
Phase phase 4
Sponsor Tina Vilsboll
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
1.8 mg liraglutide, subcutaneous, once-daily for five years
liraglutide Victoza
1.8 mg liraglutide
(Placebo Comparator)
Placebo, subcutaneous, once-daily for one year
Liraglutide without the GLP-1 analogue

Primary Outcomes

Change in glucose tolerance
time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks

Secondary Outcomes

Deterioration in glycaemic status
time frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.