Comparison of Glucovance to Insulin for Diabetes During Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | September 2002 |
| End Date: | September 2008 |
| Contact: | Lorrie A Mason, MSN |
| Email: | lorrie@rocob.com |
| Phone: | 423 664-4460 |
A Comparison of Glucovance (Glyburide and Metformin) to Insulin Therapy for the Treatment of Gestational Diabetes and Adult Onset Diabetes in Pregnancy
Pregnant women with gestational or Type 2 diabetes who require medication are placed in one
of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is
checked 5 times per day, and medication adjusted by perinatologist according to glucose
levels. The hypothesis is that patients will have similar or improved blood glucose control
on an oral agent as compared to control on insulin.
of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is
checked 5 times per day, and medication adjusted by perinatologist according to glucose
levels. The hypothesis is that patients will have similar or improved blood glucose control
on an oral agent as compared to control on insulin.
According to ACOG guidelines, patients between 24 and 28 weeks gestation will be screened
with a 1 hour glucose tolerance test (GTT) by their obstetrician. Those with elevated
glucose levels will undergo a 3 hour GTT. According to routine OB standards, if the blood
glucose is elevated on 2 or more of 4 parameters during this test (> 95 fasting, > 180 at 1
hour, > 155 at 2 hours, >140 at 3 hours), the patient will begin receiving dietary therapy
using ADA guidelines. If blood glucose levels remain 20% above a fasting of 90 & post
parandial of 120 with diet alone during a period of 1-3 weeks after diagnosis, the patient
will be invited to participate in this study. Type 2 diabetics who have been diagnosed prior
to pregnancy will also be included. These patients may enroll in the study prior to 24 weeks
gestation, entering at the time of referral. Patients who give consent for participation
will be randomly assigned to either insulin therapy (the usual standard of care), or to oral
Glucovance therapy (the experimental group). Glucovance will be started at 1.25mg/250mg BID.
NPH & regular Insulin will be started on a 1unit/kg basis BID. Both groups will receive care
according to the current standard for gestational diabetics and pregnant Type 2 diabetics.
The perinatologist and diabetes educator will evaluate the blood glucose record and assess
the patient’s adherence to the ADA diet weekly and will determine when the insulin or
Glucovance needs to be increased. If the patients in the Glucovance group continue to be
poorly controlled with 4 tablets/day (5mg/500mg), the therapy will be continued and insulin
will be added to the management. Statistical analysis will compare the two groups for myriad
factors including vaginal versus operative deliveries, hemoglobin A1C, fructosamine, and
glucose at delivery, infant birth weight, infant complications, initial infant blood
glucose.
with a 1 hour glucose tolerance test (GTT) by their obstetrician. Those with elevated
glucose levels will undergo a 3 hour GTT. According to routine OB standards, if the blood
glucose is elevated on 2 or more of 4 parameters during this test (> 95 fasting, > 180 at 1
hour, > 155 at 2 hours, >140 at 3 hours), the patient will begin receiving dietary therapy
using ADA guidelines. If blood glucose levels remain 20% above a fasting of 90 & post
parandial of 120 with diet alone during a period of 1-3 weeks after diagnosis, the patient
will be invited to participate in this study. Type 2 diabetics who have been diagnosed prior
to pregnancy will also be included. These patients may enroll in the study prior to 24 weeks
gestation, entering at the time of referral. Patients who give consent for participation
will be randomly assigned to either insulin therapy (the usual standard of care), or to oral
Glucovance therapy (the experimental group). Glucovance will be started at 1.25mg/250mg BID.
NPH & regular Insulin will be started on a 1unit/kg basis BID. Both groups will receive care
according to the current standard for gestational diabetics and pregnant Type 2 diabetics.
The perinatologist and diabetes educator will evaluate the blood glucose record and assess
the patient’s adherence to the ADA diet weekly and will determine when the insulin or
Glucovance needs to be increased. If the patients in the Glucovance group continue to be
poorly controlled with 4 tablets/day (5mg/500mg), the therapy will be continued and insulin
will be added to the management. Statistical analysis will compare the two groups for myriad
factors including vaginal versus operative deliveries, hemoglobin A1C, fructosamine, and
glucose at delivery, infant birth weight, infant complications, initial infant blood
glucose.
Inclusion Criteria:Gestational diabetes by ACOG definition or Type 2 diabetes in pregnancy
Hyperglycemia despite following ADA diet English or Spanish speaking -
Exclusion Criteria:Already requiring Insulin Serum creatinine > 1.3 or creatinine
clearance < 75ml/minute Liver disease
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