MeDiGes Study: Metformine Use in Gestational Diabetes

NCT04222348 | Unknown Phase 3

• 1 other identifier: FIM-MET-2015-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes, Gestational; Perinatal Disorder; Puerperal Disorder

Outcome Measures

Primary Outcomes (3)

• Metformin benefits

  Change of Weigth

  50 weeks

• Good glycemic control

  Change of glycemic levels

  50 weeks

• Baby wellness

  Weight

  Delivery

Secondary Outcomes (9)

• Adverse event profile

  50 weeks

• Fructosamine as a marker of insulinization

  50 weeks

• Satisfaction with the treatment

  50 weeks

• IL-6 profile

  50 weeks

• IL-10 profile and oxidativge stress as well as in lipid profile

  50 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

850-2550 mg every 24h.

Drug: Metformin; Drug: Insulin Detemir

Insulin Detemir

ACTIVE COMPARATOR

Individual doses according to glycemic controls.

Drug: Metformin; Drug: Insulin Detemir

Interventions

Metformin DRUG

850-2550 mg every 24h.

Insulin Detemir; Metformin

Insulin Detemir DRUG

Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.

Insulin Detemir; Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old.
• Diagnosis of GD, with fasting glucose \<120 mg / dL.
• 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.
• nd or 3rd trimesters of pregnancy.
• Able to give informed consent.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes, Gestational; Puerperal Disorders

Interventions

Metformin; Insulin Detemir

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Inferiority, randomized, open, parallel arms, multicenter clinical trial

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: January 10, 2020
• Study Start: October 26, 2016
• Primary Completion: May 28, 2020
• Study Completion: July 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share