Trial Outcomes & Findings for Metformin Compared to Glyburide in Gestational Diabetes (NCT NCT00965991)

Last Updated: 2024-11-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

149 participants

Primary outcome timeframe

fasting and 2 hour postprandial blood glucose

Results posted on

2024-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	75	74
Overall Study COMPLETED	75	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 1: Metformin n=75 Participants 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	ARM 2: Glyburide n=74 Participants 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	Total n=149 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=75 Participants	0 Participants n=74 Participants	0 Participants n=149 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=75 Participants	74 Participants n=74 Participants	149 Participants n=149 Participants
Age, Categorical >=65 years	0 Participants n=75 Participants	0 Participants n=74 Participants	0 Participants n=149 Participants
Age, Continuous	31 years STANDARD_DEVIATION 7.1 • n=75 Participants	30 years STANDARD_DEVIATION 7.8 • n=74 Participants	30 years STANDARD_DEVIATION 7.4 • n=149 Participants
Sex: Female, Male Female	75 Participants n=75 Participants	74 Participants n=74 Participants	149 Participants n=149 Participants
Sex: Female, Male Male	0 Participants n=75 Participants	0 Participants n=74 Participants	0 Participants n=149 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	75 participants n=75 Participants	74 participants n=74 Participants	149 participants n=149 Participants

PRIMARY outcome

Timeframe: fasting and 2 hour postprandial blood glucose

Outcome measures

Outcome measures
Measure	Metformin n=75 Participants 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	Glyburide n=74 Participants Glyburide: Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose
Number of Participants Assessed for Glucose Control	50 Participants	50 Participants

Adverse Events

ARM 1: Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ARM 2: Glyburide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Moore

University of New Mexico

Phone: 5052727028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place