A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus
Overview[ - collapse ][ - ]
Purpose | Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG recommend glucose control in order to reduce the incidence of hyperglycemia induced complications. Glucose control can be achieved using diet and life style changes. Insulin is initiated in women who fail to obtain glucose control with diet alone. During the past 11 years oral hypoglycemic drugs have been tested and proven to be efficacious and safe. Objectives 1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of women diagnosed with GDM 2. To evaluate the improvement in glycemic control after the addition of a second oral hypoglycemic drug after failure of the first Hypothesis GDM is one of the major conditions contributing to obstetrical complications and prenatal morbidity. Improving glycemic control, by means of improving compliance and patient satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and have positive long term health implications. Study design Prospective, randomized, open label Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at or after 13 weeks of gestation. Study period From recruitment until discharge of the newborn baby after delivery Power analysis Assuming 80% glycemic control with glybenclamide vs 55% with metformin, 52 women will be needed in each group in order to detect 25% difference in glycemic control rate with α=0.05 and β=0.2. Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will be collected. Average glucose levels during the previous two weeks, estimated fetal weight and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol after 38 w of gestation will be according to our ward's protocol. The study was approved by the local Helsinki committee. Time table Duration: two years |
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Condition | Gestational Diabetes Mellitus |
Intervention | Drug: metformin Drug: glybenclamide |
Phase | Phase 4 |
Sponsor | HaEmek Medical Center, Israel |
Responsible Party | HaEmek Medical Center, Israel |
ClinicalTrials.gov Identifier | NCT01563120 |
First Received | December 28, 2011 |
Last Updated | March 23, 2012 |
Last verified | March 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 28, 2011 |
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Last Updated Date | March 23, 2012 |
Start Date | January 2012 |
Estimated Primary Completion Date | January 2014 |
Current Primary Outcome Measures | glycemic control [Time Frame: 2 years] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus |
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Official Title | Not Provided |
Brief Summary | Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG recommend glucose control in order to reduce the incidence of hyperglycemia induced complications. Glucose control can be achieved using diet and life style changes. Insulin is initiated in women who fail to obtain glucose control with diet alone. During the past 11 years oral hypoglycemic drugs have been tested and proven to be efficacious and safe. Objectives 1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of women diagnosed with GDM 2. To evaluate the improvement in glycemic control after the addition of a second oral hypoglycemic drug after failure of the first Hypothesis GDM is one of the major conditions contributing to obstetrical complications and prenatal morbidity. Improving glycemic control, by means of improving compliance and patient satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and have positive long term health implications. Study design Prospective, randomized, open label Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at or after 13 weeks of gestation. Study period From recruitment until discharge of the newborn baby after delivery Power analysis Assuming 80% glycemic control with glybenclamide vs 55% with metformin, 52 women will be needed in each group in order to detect 25% difference in glycemic control rate with α=0.05 and β=0.2. Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will be collected. Average glucose levels during the previous two weeks, estimated fetal weight and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol after 38 w of gestation will be according to our ward's protocol. The study was approved by the local Helsinki committee. Time table Duration: two years |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Gestational Diabetes Mellitus |
Intervention | Drug: metformin metformin up to 2550mg per day. Drug: glybenclamide glybenclamide up to 20mg per day. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 104 |
Estimated Completion Date | January 2014 |
Estimated Primary Completion Date | January 2014 |
Eligibility Criteria | Inclusion Criteria: 1. Patients with GDM with a gestational age between 14-33 weeks 2. Fasting glucose over 95 mg% or over 130 mg% an hour and a half postprandial (PPD) or a daily average over 100 mg% 3. At least a week of dietary treatment 4. Sonographic dating of the pregnancy earlier than 24 weeks 5. Signing a consent form Exclusion Criteria: 1. Suspected IUGR earlier than 24 week of gestation 2. Major fetal malformation 3. Pre-gestational diabetes mellitus |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Israel |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01563120 |
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Other Study ID Numbers | 0002-11-EMC |
Has Data Monitoring Committee | Not Provided |
Information Provided By | HaEmek Medical Center, Israel |
Study Sponsor | HaEmek Medical Center, Israel |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | March 2012 |
Locations[ + expand ][ + ]
Dep. OB/GYN, Emek Medical Center | Afula, Israel |
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