Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Information source: Skane University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Secondary Drug Failure
Intervention: pioglitazone (Drug); insulin glargine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Skane University Hospital Official(s) and/or principal investigator(s): Leif Groop, Professor, Study Director, Affiliation: Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
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.
Clinical Details
Official title: Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
Secondary outcome: Effect of pioglitazone vs. insulin glargine on BNP
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
Malmö University Hospital, Malmö 20502, Sweden
Additional Information
Starting date: April 2004
Last updated: January 24, 2008
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