Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes (Liragest)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2027
  • participants needed
    80
  • sponsor
    Turku University Hospital
Updated on 23 May 2022
diabetes
insulin
type 2 diabetes mellitus
metformin
liraglutide
Accepts healthy volunteers

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.

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.

Details
Condition Gestational Diabetes
Treatment placebos, Liraglutide 6 MG/ML [Victoza]
Clinical Study IdentifierNCT04324229
SponsorTurku University Hospital
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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