drugset / Trial / NCT01756105

Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women

NCT01756105

Phase 2 Terminated 84 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupOpen-labelTreatment

Summary

Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.

Timeline

Start
2012-06
Primary completion
2018-02
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulatard Protein / enzyme biologic 5 unknown
Subject Insulatard Protein / enzyme biologic 6 unknown
Subject Insulin Lispro Protein / enzyme biologic 3 unknown
Subject Insulin Lispro Protein / enzyme biologic 4 unknown
Subject Insulin Lispro Protein / enzyme biologic 5 unknown
Subject Insulin Lispro Protein / enzyme biologic 6 unknown
Subject Metformin Small molecule 2500 mg
Subject Umuline NPH Unknown 5 unknown
Subject Umuline NPH Unknown 6 unknown
Subject insulin aspart Protein / enzyme biologic 3 unknown
Subject insulin aspart Protein / enzyme biologic 4 unknown
Subject insulin aspart Protein / enzyme biologic 5 unknown
Subject insulin aspart Protein / enzyme biologic 6 unknown

Indications