Trial Outcomes & Findings for Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes (NCT NCT00770367)

NCT ID: NCT00770367

Last Updated: 2018-08-31

Results Overview

Labs measured micro moles per liter of ADMA levels in participants.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-08-31

Participant Flow

medical clinic, 36 participants recruited

After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA > 0.50 μM/L. If not eligible would be excluded from study.

Participant milestones

Measure	Pioglitazone This is the analysis period during which participants took Pioglitazone.	Placebo The analysis period during which participant took the placebo.
First Intervention STARTED	18	18
First Intervention COMPLETED	18	16
First Intervention NOT COMPLETED	0	2
Washout Period of 4 Weeks STARTED	18	16
Washout Period of 4 Weeks COMPLETED	18	15
Washout Period of 4 Weeks NOT COMPLETED	0	1
Second Intervention STARTED	18	15
Second Intervention COMPLETED	16	15
Second Intervention NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Pioglitazone This is the analysis period during which participants took Pioglitazone.	Placebo The analysis period during which participant took the placebo.
First Intervention Withdrawal by Subject	0	2
Washout Period of 4 Weeks Withdrawal by Subject	0	1
Second Intervention Lost to Follow-up	2	0

Baseline Characteristics

Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes

Baseline characteristics by cohort

Measure	Pioglitazone n=18 Participants This is the analysis period during which participants took Pioglitazone.	Placebo n=18 Participants The analysis period during which participant took the placebo.	Total n=36 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	18 Participants n=5 Participants	18 Participants n=7 Participants	36 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	52.2 years STANDARD_DEVIATION 1.89 • n=5 Participants	55.7 years STANDARD_DEVIATION 2.42 • n=7 Participants	54 years STANDARD_DEVIATION 1.56 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.

Labs measured micro moles per liter of ADMA levels in participants.

Outcome measures

Measure	Pioglitazone n=36 Participants This is the analysis period during which participants took Pioglitazone.	Placebo n=36 Participants The analysis period during which participant took the placebo.
Asymmetric Dimethylarginine (ADMA) Level	.80 umol/L Interval 0.75 to 0.85	.75 umol/L Interval 0.71 to 0.79

SECONDARY outcome

Timeframe: 3 months

Population: 36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial.

Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress

Outcome measures

Measure	Pioglitazone n=18 Participants This is the analysis period during which participants took Pioglitazone.	Placebo n=18 Participants The analysis period during which participant took the placebo.
NOx f2-isoprostanes	-1.4 Oxidative stress Standard Error 1.4	-1 Oxidative stress Standard Error 2.6

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dana King MD

Medical University of South Carolina

Phone: 843-792-8112

Email: kingde@musc.edu

Results disclosure agreements

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