drugset / Trial / NCT06589141
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
Not yet recruiting
180 enrolled
Assiut University
Middle-Eastern College of Obstetricians and Gynecologists · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-06-30
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glyburide | Small molecule | 2.5 mg | Oral |
| Subject | Glyburide | Small molecule | 20 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 2000 mg | Oral |