CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
Pioglitazone +2 moredrug
Likely dose
Pioglitazone dose not specified in interventions or armsAI-extracted
Key inclusion· 1
  • Diagnosis of Type 2 Diabetes Mellitus
Key exclusion· 3
  • Bleeding disorders including gastrointestinal reflux disease, peptic ulcer disease, or any gastrointestinal bleeding
  • High blood pressure (uncontrolled hypertension)
  • History of Coronary Artery Disease or chest pain on exertion

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

Search/NCT00179400
NCT00179400Phase 4Completed

The Role of Acute Combined Peroxisome Proliferator-Activated Receptors (PPAR) Alpha and Gamma Stimulation on Insulin Action in Humans

Albert Einstein College of Medicine·interventional·Posted Sep 16, 2005·Updated Mar 3, 2025

In Brief

A Phase 4 clinical trial evaluating Pioglitazone, Placebo, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the acute effects of the thiazolidinedione agent pioglitazone (which has combined PPAR alpha and gamma stimulation) on insulin's ability to suppress glucose production, stimulated glucose uptake, and impact a number of other metabolically important endpoints, including production of adiponectin (a protein hormone which regulates sugar levels and fatty acid breakdown) in subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 4CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartDec 1, 2000
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 20.8 years ago

Interventions

Pioglitazonedrug

This was a randomized placebo-controlled crossover study in which subjects received both agents in random order, separated by a wash-out period. Following 10 or 21 days' intervention, subjects underwent a pancreatic clamp study.

Placebodrug

This was a randomized placebo-controlled crossover study in which subjects received both agents in random order, separated by a wash-out period. Following 10 or 21 days' intervention, subjects underwent a pancreatic clamp study.

Pancreatic Clamp Studyprocedure

During the clamp procedure, glucose (a sugar) and insulin were infused with an IV catheter, and blood samples were collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism.