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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator |
| |
| Glyburide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa E Moore, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Diabetes in Pregnancy Clinic | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20027034 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM 1: Metformin | Patients received metformin initial dose of 500 mg PO BID. Increased as necessary to a maximum dose of 2000 mg QD to control blood glucose |
| FG001 | ARM 2: Glyburide | Patients received glyburide initial dose of 2.5mg PO BID. Increased as necessary to a maximum dose of 20 mg/d to control blood glucose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM 1: Metformin | Metformin: 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 |
| BG001 | ARM 2: Glyburide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | fasting and 2 hour postprandial blood glucose |
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM 1: Metformin | Metformin: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Moore | University of New Mexico | 5052727028 | hkhawaja@salud.unm.edu |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D005905 | Glyburide |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 |
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|
| 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 |
|
|
Glyburide: Patients received glyburide initial dose of 2.5mg PO BID. Increased as necessary to a maximum dose of 20 mg/d to control blood glucose
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | ARM 2: Glyburide | Glyburide: Patients received glyburide initial dose of 2.5mg PO BID. Increased as necessary to a maximum dose of 20 mg/d to control blood glucose | 0 | 74 | 0 | 74 | 0 | 74 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |