Efficacy of metformin in gestational diabetes

Phase 1

• Conditions: Gestational diabetes (GD); MedDRA version: 18.0Level: PTClassification code 10018209Term: Gestational diabetesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-000361-31-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-10
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified