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MeDiGes Study: Metformine Use in Gestational Diabetes

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA INVESTIGACIÓN DE MÁLAGA EN BIOMEDICINA Y SALUD · Jan 7, 2020

Trial Information

Current as of June 23, 2025

Unknown status

Keywords

ClinConnect 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.

The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes ...

Gender

FEMALE

Eligibility criteria

  • 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.

About Fundación Pública Andaluza Para La Investigación De Málaga En Biomedicina Y Salud

The Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is a prominent public foundation dedicated to advancing biomedical research and health initiatives in the Andalusia region of Spain. Committed to fostering innovation and collaboration, the foundation supports a wide array of clinical trials aimed at improving health outcomes and enhancing scientific knowledge. By integrating cutting-edge research with clinical practice, it strives to contribute significantly to the development of new therapeutic strategies and health solutions, ultimately benefiting patients and the broader healthcare community.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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