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CompletedNCT00609856Updated Feb 7, 2008

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

A Phase 4 interventional study of pioglitazone and insulin glargine in Type 2 Diabetes and Secondary Drug Failure, sponsored by Skane University Hospital. Completed at 1 site in Sweden. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-02-07.

Sponsored by Skane University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Type 2 Diabetes
  • Secondary Drug Failure
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 36 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • type 2 diabetes
  • inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin

Exclusion criteria

Exclusion Criteria:

  • heart failure (NYHA II-IV)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    1

    Pioglitazone

    Drug: pioglitazone

  • Active comparator
    2

    Insulin glargine

    Drug: insulin glargine

Interventions

  • Drugpioglitazone

    tablet, 30 mg, once daily, 26 weeks

    Also known as: Actos

  • Druginsulin glargine

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

    Also known as: Lantus

06

What researchers measure

Primary outcomes

  1. Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity

    Time frame: 26 weeks

Secondary outcomes

  1. Effect of pioglitazone vs. insulin glargine on BNP

    Time frame: 26 weeks

07

Study locations

1 site
  • Malmö University Hospital
    Malmö, 20502, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00609856
Lead sponsor
Skane University Hospital
Collaborators
Medical Research Council, Skane County Council Research & Development Foundation
First posted
Feb 7, 2008
Start date
Apr 2004
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Feb 7, 2008

Study contacts

Leif Groop, Professor
study director · Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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