A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus
1 other identifier
interventional
108
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Typical duration for phase_4
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
First Submitted
Initial submission to the registry
December 28, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 1, 2016
October 1, 2016
2.4 years
December 28, 2011
October 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
glycemic control
2 years
Study Arms (2)
metformin
ACTIVE COMPARATORmetformin up to 2550mg per day
glybenclamide
ACTIVE COMPARATORglybenclamide up to 20mg per day.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with GDM with a gestational age between 14-33 weeks
- Fasting glucose over 95 mg% or over 130 mg% an hour and a half postprandial (PPD) or a daily average over 100 mg%
- At least a week of dietary treatment
- Sonographic dating of the pregnancy earlier than 24 weeks
- Signing a consent form
You may not qualify if:
- Suspected IUGR earlier than 24 week of gestation
- Major fetal malformation
- Pre-gestational diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dep. OB/GYN, Emek Medical Center
Afula, Israel
Related Publications (1)
Nachum Z, Zafran N, Salim R, Hissin N, Hasanein J, Gam Ze Letova Y, Suleiman A, Yefet E. Glyburide Versus Metformin and Their Combination for the Treatment of Gestational Diabetes Mellitus: A Randomized Controlled Study. Diabetes Care. 2017 Mar;40(3):332-337. doi: 10.2337/dc16-2307. Epub 2017 Jan 11.
PMID: 28077460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2011
First Posted
March 26, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
November 1, 2016
Record last verified: 2016-10