Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Interventio

• Conditions: Gestational diabetes mellitus.; MedDRA version: 17.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-001244-38-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-23
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

1. Confirmed singleton viable pregnancy
2. Between 8 and 22 weeks gestation
3. History of a previous pregnancy complicated by gestational diabetes mellitus
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Established pre-existing diabetes (including unrecognised diabetes defined as FPG = 7.0mmol/L and/ or HbA1c = 48mmol/mol)
2. Contraindications to metformin therapy
a. Renal impairment: creatinine = 130µmol/L
b. Impaired liver function (ALT = 2.0 x upper limit normal)
c. Previous intolerance to metformin
3. Planned continued antenatal care/ delivery at centre not included in trial
4. Planned fast for cultural/ religious reasons e.g. Ramadan

Study & Design

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