Trial Outcomes & Findings for Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo (NCT NCT00744965)

NCT ID: NCT00744965

Last Updated: 2020-03-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 395 participants
• Primary outcome timeframe: Immediately after delivery of fetus
• Results posted on: 2020-03-12

Participant Flow

Participant milestones

Measure	Placebo Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Overall Study STARTED	197	198
Overall Study COMPLETED	186	189
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Baseline characteristics by cohort

Measure	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Total n=375 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	189 Participants n=5 Participants	186 Participants n=7 Participants	375 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.3 years STANDARD_DEVIATION 6 • n=5 Participants	31.2 years STANDARD_DEVIATION 6 • n=7 Participants	31.2 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants	186 Participants n=7 Participants	375 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	189 Participants n=5 Participants	186 Participants n=7 Participants	375 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after delivery of fetus

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Mean Fetal Weight at Birth	3355 grams Standard Deviation 521	3322 grams Standard Deviation 481

SECONDARY outcome

Timeframe: After delivery

Birth weight exceeding the 90th percentile for the gestational age at delivery.

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Number of Participants With Large for Gestational Age Infants	22 Participants	20 Participants

SECONDARY outcome

Timeframe: After delivery

birth weight 4,000 g or greater

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Macrosomia	18 Participants	13 Participants

SECONDARY outcome

Timeframe: Until hospital discharge

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Neonatal Intensive Care Unit Admissions	11 Participants	13 Participants

SECONDARY outcome

Timeframe: After delivery

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Rate of Cesarean Delivery	67 Participants	70 Participants

SECONDARY outcome

Timeframe: until hospital discharge

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Diagnosis of Pregnancy-induced Hypertension	12 Participants	15 Participants

SECONDARY outcome

Timeframe: at delivery

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Shoulder Dystocia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: after delivery

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Need for Insulin Treatment	4 Participants	4 Participants

SECONDARY outcome

Timeframe: at delivery

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
3rd or 4th Degree Perineal Laceration	5 Participants	1 Participants

SECONDARY outcome

Timeframe: intrapartum

Maternal fever >=38.0°C

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Chorioamnionitis	12 Participants	15 Participants

SECONDARY outcome

Timeframe: throughout pregnancy and delivery

Outcome measures

Measure	Placebo n=186 Participants Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 Participants Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Need for Insulin Therapy	4 Participants	4 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glyburide

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=186 participants at risk Women with mild gestational diabetes will be started ADA diet and placebo. Placebo: Sham dose adjustments of the placebo will be made.	Glyburide n=189 participants at risk Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Endocrine disorders facial swelling	0.00% 0/186 • approximately 3-4 months (throughout the duration of study participation)	0.53% 1/189 • Number of events 1 • approximately 3-4 months (throughout the duration of study participation)

Other adverse events

Adverse event data not reported

Additional Information

Kenneth J. Leveno, MD

UT Southwestern Medical Center

Phone: 214-648-2316

Email: kenneth.leveno@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place