MeDiGes Study: Metformine Use in Gestational Diabetes (FIMMET201501)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status and phase: Unknown; Phase 3

Conditions: Diabetes, Gestational; Perinatal Disorder; Puerperal Disorder

Treatments: Drug: Insulin Detemir; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04222348

FIM-MET-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-45 years old.
2. Diagnosis of GD, with fasting glucose <120 mg / dL.
3. not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week.
4. 2nd or 3rd trimesters of pregnancy.
5. Able to give informed consent.

Exclusion criteria

1. Psychopathological situations that do not guarantee proper adhesion to follow up
2. 1st trimester of pregnancy
3. gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
4. Patients who can not attend the scheduled consultation.
5. Language barrier limiting for understanding treatment settings
6. Twin pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Metformin

Experimental group

Description:

850-2550 mg every 24h.

Treatment:

Drug: Insulin Detemir

Drug: Metformin

Insulin Detemir

Active Comparator group

Description:

Individual doses according to glycemic controls.

Treatment:

Drug: Insulin Detemir

Drug: Metformin