Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MetFORMIN 500 Mg Oral Tablet, GlyBURIDE 2.5 MG Oral Tablet.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus in Pregnancy. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
Overview
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
Interventions
- 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)
Primary outcome measures
- Treatment failure [Time frame: From 28 weeks till 41 weeks of pregnancy]
Secondary outcome measures (3)
- Incidence of maternal hypoglycemia [Time frame: From 28 weeks till 41 weeks of pregnancy]
- Significant side effects [Time frame: From 28 weeks till 41 weeks of pregnancy]
- Fetal macrosomia (large for gestational age) [Time frame: 32 weeks of gestation to onset of labour]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Ye W, Luo C, Huang J, Li C, Liu Z, Liu F. Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2022 May 25;377:e067946. doi: 10.1136/bmj-2021-067946. PMID 35613728
- Silva JC, Fachin DR, Coral ML, Bertini AM. Perinatal impact of the use of metformin and glyburide for the treatment of gestational diabetes mellitus. J Perinat Med. 2012 Jan 10;40(3):225-8. doi: 10.1515/jpm-2011-0175. PMID 22505499
- Shuster DL, Shireman LM, Ma X, Shen DD, Flood Nichols SK, Ahmed MS, Clark S, Caritis S, Venkataramanan R, Haas DM, Quinney SK, Haneline LS, Tita AT, Manuck TA, Thummel KE, Brown LM, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Glyburide, Metformin, and Glyburide/Metformin Combination Therapy in the Treatment of Gestational Diabetes Mellitus. Clin Pharmacol Ther. 2020 Jun;107(6):13 PMID 31869430
- Oliveira MM, Andrade KFO, Lima GHS, Rocha TC. Metformin versus glyburide in treatment and control of gestational diabetes mellitus: a systematic review with meta-analysis. Einstein (Sao Paulo). 2022 Feb 16;20:eRW6155. doi: 10.31744/einstein_journal/2022RW6155. eCollection 2022. PMID 35195193
Identifiers
NCT: NCT06589141 · GDM-MERGE trial