Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Gestational Diabetes Metformin Treatment Oxidative Stress |
| Intervention | Drug: Metformin Drug: Rapid acting analog insulin Intermediate acting NPH Insulin |
| Phase | Phase 2 |
| Sponsor | University Hospital, Strasbourg, France |
| Responsible Party | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier | NCT01756105 |
| First Received | December 19, 2012 |
| Last Updated | December 19, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 19, 2012 |
|---|---|
| Last Updated Date | December 19, 2012 |
| Start Date | July 2012 |
| Estimated Primary Completion Date | February 2016 |
| Current Primary Outcome Measures | Efficacy of metformin in treatment of gestational diabetes based on capillary glycaemia with an objective of less than 6 measures out of range [Time Frame: After diagnosis of gestational diabetes and until 3 months after delivery; screening made between 22th and 28th week of gestation] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women |
|---|---|
| Official Title | Gestational Diabetes in Non Obese Women and Metformine |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Metformin Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of Drug: Rapid acting analog insulin Intermediate acting NPH Insulin Insulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 600 |
| Estimated Completion Date | February 2016 |
| Estimated Primary Completion Date | February 2016 |
| Eligibility Criteria | Inclusion Criteria: Women. - Age more than 18 and less than 40 years. - Unique spontaneous pregnancy.-BMI less than 30kg/m2 before pregnancy. - 24 to 30 weeks of amenorrhea or 22 to 28 weeks of gestation. - Gestational diabetes. - Social Security affiliated subject.- Patient able to understand and signed informed consent. Exclusion Criteria: - Contraindications to metformin. - Metformin treatment prior to protocol inclusion. - Multiple pregnancies. - Diabetes diagnosed prior to pregnancy. - High blood pressure prior to pregnancy. - Pregnancy hepatic complication - High blood pressure prior to study inclusion. - Pre or eclampsia.- Premature membranes rupture. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Nathalie Jeandidier, MD 03 88 11 66 03 nathalie.jeandidier@chru-strasbourg.fr |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01756105 |
|---|---|
| Other Study ID Numbers | 4965 |
| Has Data Monitoring Committee | No |
| Information Provided By | University Hospital, Strasbourg, France |
| Study Sponsor | University Hospital, Strasbourg, France |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Nathalie Jeandidier, MD University Hospital, Strasbourg, France |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Hôpitaux Civils de Colmar | Colmar, France, 68024 Contact: Michel GERSON, MD | O3 89 12 42 240033 | michel.gerson@ch-colmar.frPrincipal Investigator: michel Gerson, Md Not yet recruiting |
|---|---|
| CHU Dijon, | Dijon, France, 21030 Contact: Sabine RUDONI, MD | 03.80.29.34.530033 | Sabine.rudoni@chu-dijon.frPrincipal Investigator: Sabine Rudoni, MD Not yet recruiting |
| Centre hospitalier de Mulhouse | Mulhouse, France, 68070 Contact: Sabine MILLOT, MD | 03.89.64.61.660033 | millots@ch-mulhouse.frPrincipal Investigator: Sabine Millot, MD Not yet recruiting |
| CHU de Reims | Reims, France, 51092 Contact: Maud FRANCOIS, MD | 03 26 78 71 540033 | mfrancois@chu-reims.frPrincipal Investigator: Maud François, MD Not yet recruiting |
| Hôpitaux Universitaires de Strasbourg | Strasbourg, France, 67091 Contact: Nathalie Jeandidier, MD | 03 88 11 66 030033 | nathalie.jeandidier@chru-strasbourg.frPrincipal Investigator: Nathalie Jeandidier, MD Recruiting |