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

NCT ID: NCT01756105

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Gestational Diabetes; Metformin; Treatment; Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment by Metformin plus insulin if needed

Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of

Rapid acting analog insulin Intermediate acting NPH Insulin

Intervention Type: DRUG

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.

treatment by 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.

Group Type: ACTIVE_COMPARATOR

Rapid acting analog insulin Intermediate acting NPH Insulin

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie Jeandidier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

Hôpitaux Civils de Colmar

Colmar, , France

CHU Dijon,

Dijon, , France

Centre hospitalier de Mulhouse

Mulhouse, , France

CHU de Reims

Reims, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

4965

Identifier Type: -

Identifier Source: org_study_id