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A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01563120
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Study Description
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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

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


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: metformin Drug: glybenclamide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: metformin
metformin up to 2550mg per day
 Drug: metformin
metformin up to 2550mg per day.
Active Comparator: glybenclamide
glybenclamide up to 20mg per day.
 Drug: glybenclamide
glybenclamide up to 20mg per day.


Outcome Measures
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Primary Outcome Measures :
  1. glycemic control [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563120


Locations
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Israel
Dep. OB/GYN, Emek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01563120    
Other Study ID Numbers: 0002-11-EMC
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs