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Clinical trial

Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

ID
Name
T160/2018
Description
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.
Trial arms
Trial start
2020-02-07
Estimated PCD
2024-09-30
Trial end
2027-12-01
Status
Active (not recruiting)
Treatment
Liraglutide 6 MG/ML [Victoza]
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.
Arms:
liraglutide
Placebos
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.
Arms:
placebo
Size
80
Primary endpoint
Incidence of type 2 diabetes
from year 1 to 5
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'double blind', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-12-06

1 organization

2 products

1 indication

Organization
Turku University Hospital
Product
Liraglutide
Indication
Gestational Diabetes
Product
Placebos