Trial Outcomes & Findings for Metformin and Transient Hyperglycemia (NCT NCT01486043)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

During the 30 days of induction chemotherapy (plus or minus 2 weeks)

Results posted on

2015-01-30

Participant milestones
Measure	Metformin and Insulin Therapy For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study. For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011.
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Metformin and Transient Hyperglycemia

Baseline characteristics by cohort
Measure	Metformin and Insulin Therapy n=2 Participants Patients receiving metformin and insulin therapy.
Age, Continuous	13.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Hemoglobin A1C	5.8 % n=5 Participants
Fructosamine	193 uM n=5 Participants
# of Day of Induction at Onset of Hyperglycemia	2 days n=5 Participants

Timeframe: During the 30 days of induction chemotherapy (plus or minus 2 weeks)

Outcome measures
Measure	Metformin and Insulin Therapy n=2 Participants Patients receiving metformin and insulin therapy.
Length of Insulin Therapy (Days)	7.5 days Interval 0.0 to 15.0

Timeframe: At 1 month

Outcome measures
Measure	Metformin and Insulin Therapy n=2 Participants Patients receiving metformin and insulin therapy.
Serum Fructosamine Level	190 uM Interval 182.0 to 198.0

Timeframe: At 1 month

Outcome measures
Measure	Metformin and Insulin Therapy n=2 Participants Patients receiving metformin and insulin therapy.
Hemoglobin A1c	4.8 percent of hemoglobin Interval 4.3 to 5.3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Children's Hospital Los Angeles

Phone: 323-361-7388