MeDiGes Study: Metformine Use in Gestational Diabetes (FIMMET201501)

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes, Gestational; Perinatal Disorder; Puerperal Disorder
• Intervention / Treatment: Drug: Metformin; Drug: Insulin Detemir

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Metformin; 850-2550 mg every 24h.	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.
ACTIVE_COMPARATOR: Insulin Detemir; Individual doses according to glycemic controls.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metformin benefits	Change of Weigth	50 weeks
Good glycemic control	Change of glycemic levels	50 weeks
Baby wellness	Weight	Delivery

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2016
• Primary Completion (ANTICIPATED): May 28, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (ACTUAL): January 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Disease; Diabetes, Gestational; Puerperal Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Insulin Detemir
• Other Study ID Numbers: FIM-MET-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No