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Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

NCT04324229 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-06

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2024-09-30
Completion
2027-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324229 on ClinicalTrials.gov