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NCT Number: NCT06589141

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women over 18 years old.
  • Gestational age between 24 - 28 weeks.
  • New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test.
  • Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM).

Exclusion criteria

Patients with pre-gestational diabetes.

  • First trimester fasting blood glucose ≥105 mg/dl or HbA1c > 6.4%.
  • Major fetal anomalies.
  • Intrauterine growth restriction (IUGR) before 24 weeks.
  • Abnormal renal or liver function.
  • Contraindications to metformin or glyburide.
  • Medical treatment declined by the patient.
  • Direct indication to commence insulin (initial fasting blood glucose >= 7 mmol/l or 126 mg/dl or >= 6 mmol/l or 108 mg/dl with macrosomia or polyhydramnios).
  • Significant medical co-morbidities requiring continuous medical treatment in pregnancy.
  • Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)

Treatment and study plan

MetFORMIN 500 Mg Oral Tablet

Drug

Metformin (500 to 2000 mg orally)

GlyBURIDE 2.5 MG Oral Tablet

Drug

Glyburide (2.5 mg to 20 mg orally)

Primary outcomes

  1. Treatment failure

    Time frame: From 28 weeks till 41 weeks of pregnancy

    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

  1. Incidence of maternal hypoglycemia

    Time frame: From 28 weeks till 41 weeks of pregnancy

    Incidence of blood glucose levels below 4 mmol/L during the period of treatment

  2. Significant side effects

    Time frame: From 28 weeks till 41 weeks of pregnancy

    Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects)

  3. Fetal macrosomia (large for gestational age)

    Time frame: 32 weeks of gestation to onset of labour

    Incidence of fetuses growing above the 90th percentile on third ultrasound scan using customised growth chart

Study contacts

Contact information is provided by the study sponsor or research team.

Sherif Shazly, MSc

CONTACT

[email protected]

+447554480388

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Middle-Eastern College of Obstetricians and Gynecologists

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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