Trial Outcomes & Findings for Metformin Postpartum for GDM RCT for Reduced Weight Retention (NCT NCT01280409)

NCT ID: NCT01280409

Last Updated: 2018-11-28

Results Overview

The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
• Results posted on: 2018-11-28

Participant Flow

Participant milestones

Measure	Placebo Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Overall Study STARTED	59	55
Overall Study COMPLETED	43	36
Overall Study NOT COMPLETED	16	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin Postpartum for GDM RCT for Reduced Weight Retention

Baseline characteristics by cohort

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks	Total n=79 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	43 Participants n=5 Participants	36 Participants n=7 Participants	79 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	28.8 years STANDARD_DEVIATION 6.4 • n=5 Participants	31.6 years STANDARD_DEVIATION 5.3 • n=7 Participants	30.2 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	36 Participants n=7 Participants	79 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	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

The weight change in kilograms defined as:

weight change = Weight(pp) - Weight(6wk)

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Weight Change	6.5 kg Interval -0.3 to 12.1	6.3 kg Interval -0.3 to 19.8

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Number of Participants Who Achieved Pre-pregnancy Weight	16 Participants	15 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Number of Participants Who Achieved Their Ideal Body Weight	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Population: This data is not reported because blood samples were not analyzed for Hemoglobin a1c.

We will calculate the change in hemoglobin a1c.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Population: This data is not reported because blood samples were not analyzed for HDL, LDL, and triglyceride.

We will calculate the change in LDL, HDL, and triglyceride levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks postpartum

Population: 46 in the placebo group and 53 in the metformin group were available by phone at 3 weeks postpartum to indicate medication compliance.

Outcome measures

Measure	Placebo n=46 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=53 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Self-reported Compliance With Medications Unknown	1 Participants	4 Participants
Self-reported Compliance With Medications less than 50%	12 Participants	10 Participants
Self-reported Compliance With Medications greater than 50%	19 Participants	20 Participants
Self-reported Compliance With Medications 100%	14 Participants	19 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Self-reported Compliance With Medications greater than 50%	14 Participants	18 Participants
Self-reported Compliance With Medications Unknown	0 Participants	0 Participants
Self-reported Compliance With Medications less than 50%	1 Participants	1 Participants
Self-reported Compliance With Medications 100%	28 Participants	17 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Difficulty With Diet as Assessed by a 5-point Likert Scale Not at all	10 Participants	9 Participants
Difficulty With Diet as Assessed by a 5-point Likert Scale Slightly	9 Participants	10 Participants
Difficulty With Diet as Assessed by a 5-point Likert Scale Moderately	14 Participants	14 Participants
Difficulty With Diet as Assessed by a 5-point Likert Scale Quite	6 Participants	1 Participants
Difficulty With Diet as Assessed by a 5-point Likert Scale Extremely	4 Participants	2 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Difficulty With Exercise as Assessed by a 5-point Likert Scale Not at all	11 Participants	11 Participants
Difficulty With Exercise as Assessed by a 5-point Likert Scale Slightly	9 Participants	6 Participants
Difficulty With Exercise as Assessed by a 5-point Likert Scale Moderately	13 Participants	13 Participants
Difficulty With Exercise as Assessed by a 5-point Likert Scale Quite	4 Participants	5 Participants
Difficulty With Exercise as Assessed by a 5-point Likert Scale Extremely	6 Participants	1 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Difficulty With Medication as Assessed by a 5-point Likert Scale Not at all	15 Participants	14 Participants
Difficulty With Medication as Assessed by a 5-point Likert Scale Slightly	7 Participants	6 Participants
Difficulty With Medication as Assessed by a 5-point Likert Scale Moderately	5 Participants	7 Participants
Difficulty With Medication as Assessed by a 5-point Likert Scale Quite	6 Participants	5 Participants
Difficulty With Medication as Assessed by a 5-point Likert Scale Extremely	10 Participants	4 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Satisfaction With Diet as Assessed by a 5-point Likert Scale Not at all	2 Participants	6 Participants
Satisfaction With Diet as Assessed by a 5-point Likert Scale Slightly	5 Participants	7 Participants
Satisfaction With Diet as Assessed by a 5-point Likert Scale Moderately	9 Participants	8 Participants
Satisfaction With Diet as Assessed by a 5-point Likert Scale Quite	12 Participants	11 Participants
Satisfaction With Diet as Assessed by a 5-point Likert Scale Extremely	15 Participants	4 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Satisfaction With Exercise as Assessed by a 5-point Likert Scale Not at all	3 Participants	6 Participants
Satisfaction With Exercise as Assessed by a 5-point Likert Scale Slightly	9 Participants	6 Participants
Satisfaction With Exercise as Assessed by a 5-point Likert Scale Moderately	14 Participants	14 Participants
Satisfaction With Exercise as Assessed by a 5-point Likert Scale Quite	9 Participants	6 Participants
Satisfaction With Exercise as Assessed by a 5-point Likert Scale Extremely	8 Participants	4 Participants

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Outcome measures

Measure	Placebo n=43 Participants Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=36 Participants Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Satisfaction With Medication as Assessed by a 5-point Likert Scale Not at all	4 Participants	5 Participants
Satisfaction With Medication as Assessed by a 5-point Likert Scale Slightly	6 Participants	4 Participants
Satisfaction With Medication as Assessed by a 5-point Likert Scale Moderately	6 Participants	7 Participants
Satisfaction With Medication as Assessed by a 5-point Likert Scale Quite	11 Participants	11 Participants
Satisfaction With Medication as Assessed by a 5-point Likert Scale Extremely	16 Participants	9 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Metformin

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=56 participants at risk Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	Metformin n=46 participants at risk Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Gastrointestinal disorders Nausea	12.5% 7/56 • Number of events 7 • 3 weeks postpartum	15.2% 7/46 • Number of events 7 • 3 weeks postpartum
Gastrointestinal disorders Vomiting	5.4% 3/56 • Number of events 3 • 3 weeks postpartum	0.00% 0/46 • 3 weeks postpartum
Gastrointestinal disorders Diarrhea	10.7% 6/56 • Number of events 6 • 3 weeks postpartum	17.4% 8/46 • Number of events 8 • 3 weeks postpartum
Metabolism and nutrition disorders Hypoglycemia	5.4% 3/56 • Number of events 3 • 3 weeks postpartum	8.7% 4/46 • Number of events 4 • 3 weeks postpartum
General disorders Medication Intolerance	8.9% 5/56 • Number of events 5 • 3 weeks postpartum	4.3% 2/46 • Number of events 2 • 3 weeks postpartum

Additional Information

Dr Jerrie Refuerzo

University of Texas Health Science Center at Houston

Phone: 713.500.7780

Email: Jerrie.S.Refuerzo@uth.tmc.edu

Results disclosure agreements

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