Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Phase 4

Completed

• Conditions: Type 2 Diabetes; Secondary Drug Failure
• Interventions: Drug: pioglitazone; Drug: insulin glargine

• Registration Number: NCT00609856
• Lead Sponsor: Skane University Hospital

Brief Summary

Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.

Detailed Description

The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:

* Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test

* Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and

* Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-01
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-01-24
• Last Update Submitted: 2008-01-24
• Study First Posted: 2008-02-07
• Last Update Posted: 2008-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• type 2 diabetes
• inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin

Exclusion Criteria

• heart failure (NYHA II-IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pioglitazone	Pioglitazone
2	insulin glargine	Insulin glargine

Primary Outcome Measures

Name	Time	Method
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity	26 weeks

Secondary Outcome Measures

Name	Time	Method
Effect of pioglitazone vs. insulin glargine on BNP	26 weeks

Trial Locations

Locations (1)

Malmö University Hospital; 🇸🇪 Malmö, Sweden