Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin (PIOswitch)

December 17, 2007 updated by: IKFE Institute for Clinical Research and Development

Multi Center, Open Label Study to Evaluate the Influence of Pioglitazone Treatment Over 6 Months on Metabolic Control in Type II Diabetic Patients Previously Treated With Insulin

The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control.

Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Ikfe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes mellitus
  • insulin therapy > 1 year
  • residual ß-cell function (C-peptide increase in iv glucagon test)
  • written informed consent

Exclusion Criteria:

  • type 1 diabetes
  • oral therapy
  • life-threatening disease
  • heart failure (NYHA I-IV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
pioglitazone/glimepiride
Drug: pioglitazone and glimepiride
switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
Other Names:
  • Actos - pioglitazone
  • Amaryl - glimepiride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change of HbA1c Insulin resistance according to minimal model and HOMA-S analysis change of insulin resistance according to minimal model and HOMA-S analysis to baseline first phase insulin response
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IKFE Institute for Clinical Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATS-K-013
  • TAK-PIO-004.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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