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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576784
• Other study ID #: ATS-K-013
• Secondary ID: TAK-PIO-004.2
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: December 17, 2007
• Start date: April 2005
• Est. completion date: April 2007

Study information

• Verified date: December 2007
• Source: IKFE Institute for Clinical Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• pioglitazone and glimepiride
switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.

Locations

Country	Name	City	State
Germany	IKFE	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
IKFE Institute for Clinical Research and Development

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value		6 months	No
Secondary	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		6 months	No