Clinical trial NCT06589141: Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
Official title: Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: Metformin and Glyburide
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Middle-Eastern College of Obstetricians and Gynecologists
First posted: 2024-09-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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)

Primary outcomes:
measure: Treatment failure
timeFrame: From 28 weeks till 41 weeks of pregnancy
Secondary outcomes:
measure: Incidence of maternal hypoglycemia
timeFrame: From 28 weeks till 41 weeks of pregnancy
measure: Significant side effects
timeFrame: From 28 weeks till 41 weeks of pregnancy
measure: Fetal macrosomia (large for gestational age)
timeFrame: 32 weeks of gestation to onset of labour
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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):1362-1372. doi: 10.1002/cpt.1749. Epub 2020 Jan 25.
citation: 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.