Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

Not Applicable

Active, not recruiting

• Conditions: Gestational Diabetes
• Interventions: Drug: Liraglutide 6 MG/ML [Victoza]; Drug: Placebos

• Registration Number: NCT04324229
• Lead Sponsor: Turku University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-02-07
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-09-30
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liraglutide	Liraglutide 6 MG/ML [Victoza]	-
placebo	Placebos	-

Primary Outcome Measures

Name	Time	Method
Incidence of type 2 diabetes	from year 1 to 5	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 %

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland