MeDiGes Study: Metformine Use in Gestational Diabetes

Diabetes, Gestational Clinical Trial

— FIMMET201501  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04222348
• Other study ID #: FIM-MET-2015-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 26, 2016
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2019
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 1, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Disease
• Perinatal Disorder
• Puerperal Disorder
• Puerperal Disorders

Intervention

Drug:
• Metformin
850-2550 mg every 24h.
• Insulin Detemir
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin benefits	Change of Weigth	50 weeks
Primary	Good glycemic control	Change of glycemic levels	50 weeks
Primary	Baby wellness	Weight	Delivery
Secondary	Adverse event profile	Number of adverse events	50 weeks
Secondary	Fructosamine as a marker of insulinization	Concentration of fructosamine	50 weeks
Secondary	Satisfaction with the treatment	Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)	50 weeks
Secondary	IL-6 profile	IL-6 levels	50 weeks
Secondary	IL-10 profile and oxidativge stress as well as in lipid profile	IL-10 (ultrasensitive PCR) levels	50 weeks
Secondary	Leptin profile	Leptin levels	50 weeks
Secondary	Ladiponectin and oxidativge stress as well as in lipid profile	Ladiponectin levels	50 weeks
Secondary	LPS profile	LPS levels	50 weeks
Secondary	LBP profile and oxidativge stress as well as in lipid profile	LBP levels	50 weeks