Health TrialsbyHealthPanel

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

ConditionGestational Diabetes Mellitus in Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: MetforminExperimental treatment 1 intervention
Group B: GlyburideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure

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

Secondary outcomes

1

Incidence of maternal hypoglycemia

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

Time frame
From 28 weeks till 41 weeks of pregnancy
2

Significant side effects

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

Time frame
From 28 weeks till 41 weeks of pregnancy
3

Fetal macrosomia (large for gestational age)

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

Time frame
32 weeks of gestation to onset of labour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Middle-Eastern College of Obstetricians and Gynecologists

Sponsor institution

Middle-Eastern College of Obstetricians and Gynecologists

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: