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Clinical Trial 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.


Clinical Trial Description

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.

The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.

Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04222348
Study type Interventional
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 26, 2016
Completion date July 1, 2020

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