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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


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.


Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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