CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Pioglitazone then Placebo +1 moredrug
Likely dose
Pioglitazone then Placebo 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770367
NCT00770367Phase 4Completed
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Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes

Medical University of South Carolina·interventional·Posted Oct 10, 2008·Updated Aug 31, 2018

In Brief

A Phase 4 clinical trial evaluating Pioglitazone then Placebo and Placebo then Pioglitazone for Diabetes. Completed, enrolled 36 participants across 1 site.

Detailed Summary

SPECIFIC AIMS 1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes. 2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment. 3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
CollaboratorsTakeda Pharmaceuticals North America, Inc.

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.7 years ago

Interventions

Pioglitazone then Placebodrug

Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.

Placebo then Pioglitazonedrug

Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.