NCT00991055

Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes

To Compare the Efficacy and Safety Between Pioglitazone Added to Combination Therapy of Sulfonylurea Plus Metformin and Placebo Control Group in Patients With Type 2 Diabetes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with placebo in patients with type 2 diabetes.

Detailed description

Pioglitazone hydrochloride, a thiazolidinedione compound, is a new therapeutic agent for the treatment of type 2 diabetes that reduces insulin resistance by enhancing insulin action in skeletal muscle, liver, and adipose tissue. In the study of diabetes, pioglitazone reduced the hyperglycemia, hyperinsulinemia, and hypertriglyceridemia characteristic of insulin-resistant states. The metabolic changes induced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous models of insulin resistance. In the present randomized, double-blind, parallel study, we aim to compare the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with those of sulfonylurea plus metformin for the treatment of type 2 diabetic patients.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Pioglitazone	A total 16-week randomized, double-blind, controlled study to compare the efficacy and safety of pioglitazone 15mg once daily added to combination metformin plus sulfonylurea with those of placebo combining control group. (4-week run in period and 12-week pioglitazone 15mg added to combination therapy of sulfonylurea plus metformin and placebo control group in patients with type 2 diabetes)

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-06-01
• Completion: 2010-10-01
• First posted: 2009-10-07
• Last updated: 2009-10-07

Locations

1 site across 1 country: Taiwan