Gestational diabetes Diabetes, gestational Metformin
Conditions
Interventions
Metformin PR 750 mg oral daily. Dosage adjustment every 2 weeks until 6 weeks. The maximum dose is 2000 mg/day.,One tablet of placebo oral daily and increase to 2 tablets per day if glycemic control
Experimental Drug,Placebo Comparator Drug
MetforminPR,Placebo
Sponsors
Merck Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Singleton pregnancy, 2. Diagnosed with GDM according to institutional guideline, 3. Do not achieve glycemic target after nutritional and behavioral counseling, 4. Agree to participate
Exclusion criteria
Exclusion criteria: 1. Definite or suspect of pre-gestational diabetes, 2. Fetal congenital anomalies or deaths, 3. Suspected fetal growth restriction, 4. Currently use of metformin or other antihyperglycemic treatment regardless of indication, 5. Contraindicated for metformin use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of achievement of glycemic control At 2, 4, and 6 weeks Percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve glycemic control At 2, 4, and 6 weeks Weeks,Rate of insulin therapy At 2, 4, and 6 weeks Percentage | — |
Countries
Thailand
Contacts
Public ContactDittakarn Boriboonhirunsarn
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed