Gestational Diabetes Mellitus (GDM)
Conditions
Keywords
Gestational DIabetes Mellitus, Glyburide, Glycemic Control, Insulin Therapy, Metformin, Treatment Failure
Brief summary
The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication. The main question the study aims to answer is: Q: Is treatment failure less common with metformin or glyburide in pregnant women with GDM? The study will include 92 pregnant women aged 18-45 years with a singleton pregnancy, diagnosed with GDM between 13 and 33 weeks of pregnancy and requiring medication to control blood sugar. Participants will be randomly assigned to one of two treatment groups. Participants in the metformin group will receive metformin, starting at 850 mg once daily and increased to a maximum of 2,550 mg per day according to their blood sugar levels. Participants in the glyburide group will receive glyburide, starting at 2.5 mg twice daily and increased according to their blood sugar levels, up to a maximum of 20 mg per day. Blood glucose levels will be monitored regularly using a glucometer. Treatment will be considered successful when at least 80% of the recorded blood glucose measurements are within the target range. Treatment failure will be defined as fewer than 80% of blood glucose measurements being within the target range after up to 4 weeks of treatment. Participants who have treatment failure or cannot continue the assigned medication because of adverse effects will be switched to insulin therapy. Participants will be followed during pregnancy until delivery. The study will record treatment failure as the primary outcome and will also assess maternal outcomes, including preeclampsia, polyhydramnios, and preterm delivery, as well as newborn outcomes including macrosomia and the need for admission to a neonatal intensive care unit (NICU). The study will determine whether metformin or glyburide provides better blood sugar control and reduces the need to switch to insulin in pregnant women with gestational diabetes.
Interventions
DRUGMetformin
Starting dose for Metformin will be 850 mg once daily after a meal and/or at 10:00 p.m. The dose will be increased to twice or three times daily according to weekly blood glucose measurements, up to a maximum of 2,550 mg/day. Treatment will continue until delivery.
DRUGGlyburide
Starting dose of glyburide will be 2.5 mg twice daily, 30 minutes before meals and/or at 10:00 p.m. The dose will be increased according to weekly blood glucose measurements, up to a maximum of 20 mg/day. Treatment will continue until delivery.
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Gestational diabetes requiring drug treatment * Gestational age between 13 - 33 weeks based on history and obstetric ultrasonography
Exclusion criteria
* Known cases of diabetes mellitus * Serum creatinine \> 1.2 mg / dl * Chronic liver disease * Hypersensitivity to study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | From initiation of oral treatment, up to four weeks | Treatment failure will be defined as fewer than 80% of combined weekly blood glucose measurements being within the target range after treatment initiation. Target glucose levels are pre-prandial \<95 mg/dL and post-prandial \<140 mg/dL. Participants with treatment failure will be switched to insulin therapy. |
Countries
Pakistan
Contacts
CONTACTIqra M Principal Investigator, MBBS
CONTACTSaima A Professor, FCPS
STUDY_CHAIRSaima A Professor, FCPS
Nishtar Medical University and Hospital
Outcome results
None listed