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

• Sponsor: HaEmek Medical Center, Israel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01563120
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. glycemic control [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dep. OB/GYN, Emek Medical Center	Afula		Israel

Sponsors and Collaborators

• HaEmek Medical Center, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HaEmek Medical Center, Israel
• ClinicalTrials.gov Identifier: NCT01563120
• Other Study ID Numbers: 0002-11-EMC
• First Posted: Mar 26, 2012
• Last Update Posted: Nov 1, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Metformin; Glyburide

Study Results

No Results Posted as of Nov 1, 2016