Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

Launched by ASSIUT UNIVERSITY · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two medications, metformin and glyburide, to see which one is better for managing gestational diabetes during pregnancy. Gestational diabetes is a condition that can occur when a woman is pregnant, causing high blood sugar levels. The study will evaluate how safe and effective these medications are for both mothers and their babies, especially as alternatives to starting insulin therapy, which is another common treatment.

To participate in the trial, women must be over 18 years old and between 24 to 28 weeks pregnant with a recent diagnosis of gestational diabetes. They should have already tried changing their diet and lifestyle without enough success in controlling their blood sugar. However, women with certain medical conditions, such as pre-existing diabetes or significant health issues, would not be eligible. If you join, you can expect regular check-ins and monitoring as the study aims to provide important insights into managing gestational diabetes more effectively.

Gender

FEMALE

Eligibility criteria

• 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)