NCT04222348

MeDiGes Study: Metformine Use in Gestational Diabetes

Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes, Gestational
• Perinatal Disorder
• Puerperal Disorder

Interventions

Type	Name	Description
DRUG	Metformin	850-2550 mg every 24h.
DRUG	Insulin Detemir	Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.

Timeline

• Start date: 2016-10-26
• Primary completion: 2020-05-28
• Completion: 2020-07-01
• First posted: 2020-01-10
• Last updated: 2020-05-15