Trial | NCT00609856  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
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 Started
Apr 30
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Feb 07
2008
Estimate

Drug insulin glargine

subcutaneous injection, start dose 6-10 units, once daily, 26 weeks

  • Other names: Lantus

Drug pioglitazone

tablet, 30 mg, once daily, 26 weeks

  • Other names: Actos

1 Active Comparator

Pioglitazone

2 Active Comparator

Insulin glargine

Criteria 

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)
No Results Posted