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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01756105
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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 Intervention Phase
Gestational Diabetes
Metformin
Treatment
Oxidative Stress
Drug: Metformin
Drug: Rapid acting analog insulin Intermediate acting NPH Insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gestational Diabetes in Non Obese Women and Metformine

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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 ]

Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
Active Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756105

Contacts
Contact: Nathalie Jeandidier, MD 03 88 11 66 03 ext 0033 nathalie.jeandidier@chru-strasbourg.fr

Locations
France
Hôpitaux Civils de Colmar Not yet recruiting
Colmar, France, 68024
Contact: Michel GERSON, MD    O3 89 12 42 24 ext 0033    michel.gerson@ch-colmar.fr   
Principal Investigator: michel Gerson, Md         
CHU Dijon, Not yet recruiting
Dijon, France, 21030
Contact: Sabine RUDONI, MD    03.80.29.34.53 ext 0033    Sabine.rudoni@chu-dijon.fr   
Principal Investigator: Sabine Rudoni, MD         
Centre hospitalier de Mulhouse Not yet recruiting
Mulhouse, France, 68070
Contact: Sabine MILLOT, MD    03.89.64.61.66 ext 0033    millots@ch-mulhouse.fr   
Principal Investigator: Sabine Millot, MD         
CHU de Reims Not yet recruiting
Reims, France, 51092
Contact: Maud FRANCOIS, MD    03 26 78 71 54 ext 0033    mfrancois@chu-reims.fr   
Principal Investigator: Maud François, MD         
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Nathalie Jeandidier, MD    03 88 11 66 03 ext 0033    nathalie.jeandidier@chru-strasbourg.fr   
Principal Investigator: Nathalie Jeandidier, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Nathalie Jeandidier, MD University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01756105     History of Changes
Other Study ID Numbers: 4965
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014