Trial Outcomes & Findings for Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes (NCT NCT00678080)

NCT ID: NCT00678080

Last Updated: 2018-11-28

Results Overview

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: during third trimester
• Results posted on: 2018-11-28

Participant Flow

Participant milestones

Measure	Metformin Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Overall Study STARTED	11	14
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Metformin Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Overall Study Physician Decision	2	0
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day	Total n=21 Participants Total of all reporting groups
Age, Continuous	30.9 years STANDARD_DEVIATION 5.5 • n=5 Participants	32.3 years STANDARD_DEVIATION 4.3 • n=7 Participants	31.5 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: during third trimester

Population: During the third trimester, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 12 in the insulin arm.

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Outcome measures

Measure	Metformin n=5 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=12 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
The Number of Participants Who Achieved a Hemoglobin A1C <7%	5 Participants	12 Participants

PRIMARY outcome

Timeframe: at the time of delivery

Population: At the time of delivery, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 8 in the insulin arm.

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Outcome measures

Measure	Metformin n=5 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=8 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
The Number of Participants Who Achieved a Hemoglobin A1C <7%	5 Participants	7 Participants

SECONDARY outcome

Timeframe: at the time of delivery

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Body Mass Index	35.9 kg/m^2 Standard Deviation 5.2	40.1 kg/m^2 Standard Deviation 8.4

SECONDARY outcome

Timeframe: During pregnancy

Defined as hypoglycemia as documented by neonatal chart based on health care provider description

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants With Hypoglycemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of pregnancy

Those whose glucose levels were above target range thereby needing insulin therapy

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants Who Failed Metformin Therapy	0 Participants	—

SECONDARY outcome

Timeframe: At the time of delivery

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants Who Had a Cesarean Section	4 Participants	6 Participants

SECONDARY outcome

Timeframe: At the time of delivery

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants With Fetus With Macrosomia	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At the time of delivery

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants With Shoulder Dystocia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Neonatal period

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants Who Had a Newborn With Respiratory Distress Syndrome	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Neonatal period

Outcome measures

Measure	Metformin n=8 Participants Metformin therapy Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily	Insulin n=13 Participants Insulin Insulin (NPH and Regular): Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
Number of Participants With Newborns Who Needed Neonatal Dextrose	0 Participants	1 Participants

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin

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

Dr. Jerrie Refuerzo, M.D.

UT Health

Phone: 713-500-6416

Email: jerrie.s.refuerzo@uth.tmc.edu

Results disclosure agreements

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