Gestational Diabetes
Conditions
Keywords
Gestational diabetes, Metformin, Glyburide, oral agents
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.
Interventions
DRUGmetformin
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
DRUGGlyburide
Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Glucose Control | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| 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 | 74 |
| Total | 149 |
Baseline characteristics
| Characteristic | ARM 2: Glyburide | Total | ARM 1: Metformin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 149 Participants | 75 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 7.8 | 30 years STANDARD_DEVIATION 7.4 | 31 years STANDARD_DEVIATION 7.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 74 participants | 149 participants | 75 participants |
| Sex: Female, Male Female | 74 Participants | 149 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 0 / 75 | 0 / 74 |
| serious Total, serious adverse events | 0 / 75 | 0 / 74 |
Outcome results
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.
Time frame: fasting and 2 hour postprandial blood glucose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin | Number of Participants Assessed for Glucose Control | 50 Participants |
| Glyburide | Number of Participants Assessed for Glucose Control | 50 Participants |