Metformin Compared to Glyburide in Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
metformin
Glyburide
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring Gestational diabetes, Metformin, Glyburide, oral agents
Eligibility Criteria
Inclusion Criteria:
- Gestational diabetes not controlled with diet and exercise
Exclusion Criteria:
- history of alcohol misuse
- history of drug misuse
- Chronic hypertension requiring medication
- Renal failure
- Hepatic disease or dysfunction
- Known fetal anomaly
- Inability to give consent
- known allergy to metformin or glyburide
Sites / Locations
- University of New Mexico Diabetes in Pregnancy Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metformin
Glyburide
Arm Description
Outcomes
Primary Outcome Measures
glucose control
Secondary Outcome Measures
birthweight
delivery method
failure rate of the drug to control blood glucose
fetal macrosomia
neonatal hypoglycemia
maternal hypoglycemia
birth trauma
NICU admission
APGARs
Full Information
NCT ID
NCT00965991
First Posted
August 24, 2009
Last Updated
June 23, 2010
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT00965991
Brief Title
Metformin Compared to Glyburide in Gestational Diabetes
Official Title
A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.
Detailed Description
Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of <105mg/dl and 2 hr postprandial < 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational diabetes, Metformin, Glyburide, oral agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Title
Glyburide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Glucophage
Intervention Description
patients received glyburide initial dose of 500 mg PO BID. Increased as necessary to a maximum dose of 2000 mg QD to control blood glucose
Intervention Type
Drug
Intervention Name(s)
Glyburide
Other Intervention Name(s)
sulfonylurea
Intervention Description
Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose
Primary Outcome Measure Information:
Title
glucose control
Time Frame
fasting and 2 hour postprandial blood glucose
Secondary Outcome Measure Information:
Title
birthweight
Time Frame
postpartum
Title
delivery method
Time Frame
postpartum
Title
failure rate of the drug to control blood glucose
Time Frame
at weekly visit
Title
fetal macrosomia
Time Frame
postpartum
Title
neonatal hypoglycemia
Time Frame
postpartum
Title
maternal hypoglycemia
Time Frame
postpartum
Title
birth trauma
Time Frame
postpartum
Title
NICU admission
Time Frame
postpartum
Title
APGARs
Time Frame
postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gestational diabetes not controlled with diet and exercise
Exclusion Criteria:
history of alcohol misuse
history of drug misuse
Chronic hypertension requiring medication
Renal failure
Hepatic disease or dysfunction
Known fetal anomaly
Inability to give consent
known allergy to metformin or glyburide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa E Moore, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Diabetes in Pregnancy Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20027034
Citation
Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
Results Reference
result
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Metformin Compared to Glyburide in Gestational Diabetes
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