NCT06589141

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes. The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.

Detailed description

Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects. Secondary Outcomes: Maternal: * Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment * Incidence of maternal hypoglycemia * Reported maternal side effects * Maternal weight gain * Preterm delivery * Development of pregnancy-induced hypertension * Labor dystocia. * Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion) * Mode of delivery * Incidence of third and fourth perineal tear Fetal and neonatal: * Fetal large for gestational age * Intrauterine fetal death * Newborn weight * Gestational age at delivery * Neonatal birth injuries * Stillbirth and neonatal death * Apgar score at 1 minute

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DRUG	MetFORMIN 500 Mg Oral Tablet	Metformin (500 to 2000 mg orally)
DRUG	GlyBURIDE 2.5 MG Oral Tablet	Glyburide (2.5 mg to 20 mg orally)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-09-19
• Last updated: 2024-09-19