drugset / Trial / NCT03928340
Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.
Phase 4
Completed
80 enrolled
Kasr El Aini Hospital
Amal Kotb Abdallah · collabAmir Gabr · collabMohamed Abdeltawwab Mahmoud · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.
Timeline
- Start
- 2019-04-29
- Primary completion
- 2020-03-29
- Completion
- 2020-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1 g | — |
| Background | Insulin | Protein / enzyme biologic | — | — |