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

Primary Purpose

Type 2 Diabetes Mellitus, Insulin Resistance

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
pioglitazone and glimepiride
Sponsored by
IKFE Institute for Clinical Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes, insulin treatment, ß-cell function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • IKFE

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

pioglitazone/glimepiride

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2007
Last Updated
December 17, 2007
Sponsor
IKFE Institute for Clinical Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00576784
Brief Title
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
Acronym
PIOswitch
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IKFE Institute for Clinical Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin Resistance
Keywords
type 2 diabetes, insulin treatment, ß-cell function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
pioglitazone/glimepiride
Intervention Type
Drug
Intervention Name(s)
pioglitazone and glimepiride
Other Intervention Name(s)
Actos - pioglitazone, Amaryl - glimepiride
Intervention Description
switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
IKFE
City
Mainz
ZIP/Postal Code
55116
Country
Germany

12. IPD Sharing Statement

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

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