MetFORMIN 500 Mg Oral Tablet
DrugMetformin (500 to 2000 mg orally)
NCT Number: NCT06589141
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.
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Not applicable
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:
Fetal and neonatal:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with pre-gestational diabetes.
Metformin (500 to 2000 mg orally)
Glyburide (2.5 mg to 20 mg orally)
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
Time frame: From 28 weeks till 41 weeks of pregnancy
Incidence of blood glucose levels below 4 mmol/L during the period of treatment
Time frame: From 28 weeks till 41 weeks of pregnancy
Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects)
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
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
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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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