drugset / Trial / NCT01329016
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
Phase 1/2
Completed
177 enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Indiana University · collabRTI International · collabUniversity of Pittsburgh · collabUniversity of Texas · collabUniversity of Washington · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-02-28
- Completion
- 2015-02-28
Publications
- Results Liao MZ, Flood Nichols SK, Ahmed M, Clark S, Hankins GD, Caritis S, Venkataramanan R, Haas D, Quinney SK, Haneline LS, Tita AT, Manuck T, Wang J, Thummel KE, Brown LM, Ren Z, Easterling TR, Hebert MF. Effects of Pregnancy on the Pharmacokinetics of Metformin. Drug Metab Dispos. 2020 Apr;48(4):264-271. doi: 10.1124/dmd.119.088435. Epub 2020 Jan 24.
- Results 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.
- Results 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, Morris Brown L, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Metformin in Pregnant Women With Gestational Diabetes Mellitus and Nonpregnant Women With Type 2 Diabetes Mellitus. J Clin Pharmacol. 2020 Apr;60(4):540-549. doi: 10.1002/jcph.1549. Epub 2019 Nov 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glyburide | Small molecule | 2.5 mg | Oral |
| Comparator | Metformin | Small molecule | 500 mg | Oral |