Metformin Compared to Glyburide in Gestational Diabetes
A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedResults Posted
Study results publicly available
December 21, 2023
CompletedNovember 19, 2024
October 1, 2024
4.8 years
August 24, 2009
August 23, 2023
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Assessed for Glucose Control
The importance of exercise in the management of blood glucose was emphasized, and 30 minutes of walking per day was recommended. Patients received instruction from a nurse educator or a certified diabetes educator regarding diet and the use of the glucometer. Number of participants with a glucose level \<100 mg/dL.
fasting and 2 hour postprandial blood glucose
Study Arms (2)
Metformin
ACTIVE COMPARATORGlyburide
ACTIVE COMPARATORInterventions
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
Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose
Eligibility Criteria
You may qualify if:
- Gestational diabetes not controlled with diet and exercise
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Diabetes in Pregnancy Clinic
Albuquerque, New Mexico, 87131, United States
Related Publications (1)
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.
PMID: 20027034RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Moore
- Organization
- University of New Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa E Moore, MD
University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 26, 2009
Study Start
July 1, 2003
Primary Completion
May 1, 2008
Study Completion
August 1, 2023
Last Updated
November 19, 2024
Results First Posted
December 21, 2023
Record last verified: 2024-10