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MeDiGes Study: Metformine Use in Gestational Diabetes

NCT04222348 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-05-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-26
Primary Completion
2020-05-28
Completion
2020-07-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222348 on ClinicalTrials.gov