A Phase 4 interventional study of Metformin and Glyburide in Gestational Diabetes Mellitus (GDM), sponsored by Nishtar Medical University. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Nishtar Medical University · Phase 4, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 92 is below the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive metformin orally, once daily
Drug: Metformin
Participants will receive glyburide orally, twice daily
Drug: Glyburide
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.
Also known as: Glucophage
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.
Treatment Failure
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.
Time frame: From initiation of oral treatment, up to four weeks
Polyhydramnios
Incidence of polyhydramnios based on an amniotic fluid index \>24 ± 2 cm measured by obstetric ultrasonography.
Time frame: From enrollment in the study up to delivery (till 42 weeks of gestation)
Preterm Delivery
Incidence of delivery occurring before 37 completed weeks of gestation.
Time frame: From enrollment in the study up to delivery of the fetus (till 42 weeks of gestation)
Macrosomia
Incidence of newborn birth weight greater than 4,000 grams.
Time frame: At delivery, with newborn birth weight assessed immediately after birth within three hours
NICU Admission
Number and proportion of newborn requiring admission to the neonatal intensive care unit according to institutional criteria
Time frame: From birth through discharge from birth hospitalization, up to 48 hours
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glyburide
Nishtar Medical University