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OpenTrials
Completed

NCT Number: NCT00965991

Metformin Compared to Glyburide in Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Diabetes in Pregnancy Clinic

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: Glucophage

Glyburide

Drug

Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose

Other names: sulfonylurea

Primary outcomes

  1. Number of Participants Assessed for Glucose Control

    Time frame: fasting and 2 hour postprandial blood glucose

    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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes

Important dates

Study start
2003
Primary completion
2008
Study completion
2023
First posted
Aug 26, 2009
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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