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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00576784
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : December 19, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Insulin Resistance Drug: pioglitazone and glimepiride Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576784


Locations
Germany
IKFE
Mainz, Germany, 55116
Sponsors and Collaborators
IKFE Institute for Clinical Research and Development
More Information

Responsible Party: Prof. Thomas Forst, IKFE
ClinicalTrials.gov Identifier: NCT00576784     History of Changes
Other Study ID Numbers: ATS-K-013
TAK-PIO-004.2
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: December 2007

Keywords provided by IKFE Institute for Clinical Research and Development:
type 2 diabetes
insulin treatment
ß-cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Pioglitazone
Glimepiride
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors