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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00609856
Enrollment
36
Registered
2008-02-07
Start date
2004-04-30
Completion date
2006-12-31
Last updated
2008-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Drug Failure, Type 2 Diabetes

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.

Interventions

DRUGpioglitazone

tablet, 30 mg, once daily, 26 weeks

DRUGinsulin glargine

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

Sponsors

Medical Research Council
CollaboratorOTHER_GOV
Skane County Council Research & Development Foundation
CollaboratorUNKNOWN
Skane University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity26 weeks

Secondary

MeasureTime frame
Effect of pioglitazone vs. insulin glargine on BNP26 weeks

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026