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

Type 2 Diabetes Clinical Trial

Official title:

Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609856
• Other study ID #: Dnr 111/2004
• Secondary ID: 0
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: January 24, 2008
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Neoplasm Metastasis
• Secondary Drug Failure
• Type 2 Diabetes

Intervention

Drug:
• pioglitazone
tablet, 30 mg, once daily, 26 weeks
• insulin glargine
subcutaneous injection, start dose 6-10 units, once daily, 26 weeks

Locations

Country	Name	City	State
Sweden	Malmö University Hospital	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Skane University Hospital	Medical Research Council, Skane County Council Research & Development Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity		26 weeks	No
Secondary	Effect of pioglitazone vs. insulin glargine on BNP		26 weeks	No