MeDiGes Study: Metformine Use in Gestational Diabetes

Phase 3

• Conditions: Perinatal Disorder; Puerperal Disorder; Diabetes, Gestational
• Interventions: Drug: Metformin; Drug: Insulin Detemir

• Registration Number: NCT04222348
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief 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.

Study Timeline

• Study Start: 2016-10-26
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15
• Primary Completion: 2020-05-28
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Detemir	Metformin	Individual doses according to glycemic controls.
Metformin	Metformin	850-2550 mg every 24h.
Insulin Detemir	Insulin Detemir	Individual doses according to glycemic controls.
Metformin	Insulin Detemir	850-2550 mg every 24h.

Primary Outcome Measures

Name	Time	Method
Metformin benefits	50 weeks	Change of Weigth
Good glycemic control	50 weeks	Change of glycemic levels
Baby wellness	Delivery	Weight

Secondary Outcome Measures

Name	Time	Method
Adverse event profile	50 weeks	Number of adverse events
Fructosamine as a marker of insulinization	50 weeks	Concentration of fructosamine
Satisfaction with the treatment	50 weeks	Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
IL-6 profile	50 weeks	IL-6 levels
IL-10 profile and oxidativge stress as well as in lipid profile	50 weeks	IL-10 (ultrasensitive PCR) levels
Leptin profile	50 weeks	Leptin levels
Ladiponectin and oxidativge stress as well as in lipid profile	50 weeks	Ladiponectin levels
LPS profile	50 weeks	LPS levels
LBP profile and oxidativge stress as well as in lipid profile	50 weeks	LBP levels