Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

Study Overview
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Brief Summary
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Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery. Aim of the study is to investigate if 12 months' liraglutide treatment could decrease the risk of T2D in obese women who have had gestational diabetes. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group, once daily. Same laboratory tests are taken and instructions given at baseline 6 month and one year. After one year visits once a year until 5 years with same laboratory tests and measurements are taken.

Detailed Description
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Incidence of type 2 diabetes (T2D) is increasing along with pandemia of obesity. Gestational diabetes is the major risk factor for T2D in women and more than every tenth will develop gestational diabetes during pregnancy. T2D can be prevented by weight loss. Health care professionals should take advantage of this opportunity to prevent this devastating disease in women. Aim of the study is to investigate if 12 months' liraglutide treatment (1.8 mg) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin. 100 women, who have had gestational diabetes with treatment with metformin and/or insulin and who have stopped lactation and are not pregnant are enrolled between 6 to 18 months after delivery. BMI should be ≥30 kg/m2. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group. Both treatments are given by similar device s.c. once daily during 365 days. Before starting the treatment, clinical examination and laboratory test are done. Similar dietary instructions are given. Same laboratory tests are taken and instructions given at 6 months and at one year after baseline. Additional follow-up call (AE reporting) is scheduled at 3 months and a drug dispensing visit at 9 months. After one year visits once a year until 5 years with same laboratory tests and measurements are taken. Primary end-point is development of T2D (fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in oral glucose tolerance test 75g, and/or HbA1c≥ 6.5 %) from year 1 to 5.

Official Title
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Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: Liraglutide 6 MG/ML [Victoza]
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of gestational diabetes with treatment with metformin and/or insulin delivery 6 to 18 months before screening BMI ≥30 kg/m2 use of contraceptives (IU-device or oral contraceptive) Exclusion Criteria: lactation pregnancy type 1 or type 2 diabetes use of antidepressives, statins or anti-hyperglycemic therapies severe hepatic insufficiency end stage renal disease history of pancreatitis
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liraglutide<br> | Drug: Liraglutide 6 MG/ML [Victoza]<br>* Starting dose of liraglutide 0.6 mg will be administered for one week, after which dose will be escalated to liraglutide 1.2 mg for one week and thereafter liraglutide 1.8 mg s.c. daily injections.<br>|
| Placebo Comparator: placebo<br> | Drug: Placebos<br>* Starting dose of placebo 0.1 ml will be administered for one week, after which dose will be escalated to placebo 0.2 ml for one week and thereafter placebo 0.3 ml s.c. daily injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of type 2 diabetes | assessed by fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in oral glucose tolerance test (OGTT) 75g, and/or HbA1c≥ 6.5 % | from year 1 to 5 |