drugset / Trial / NCT04222348
MeDiGes Study: Metformine Use in Gestational Diabetes
Phase 3
Unknown
200 enrolled
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
RandomizedParallel-groupOpen-labelTreatment
Summary
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
Timeline
- Start
- 2016-10-26
- Primary completion
- 2020-05-28
- Completion
- 2020-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 850 mg | — |
| Subject | Metformin | Small molecule | 2550 mg | — |
| Subject | insulin detemir | Protein / enzyme biologic | — | — |