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

This study has been completed.
Sponsor:
Information provided by:
IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:
NCT00576784
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Insulin Resistance
 Drug: pioglitazone and glimepiride
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IKFE Institute for Clinical Research and Development:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2005
Study Completion Date: April 2007
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576784

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

No publications provided

Responsible Party: Prof. Thomas Forst, IKFE
ClinicalTrials.gov Identifier: NCT00576784     History of Changes
Other Study ID Numbers: ATS-K-013, TAK-PIO-004.2
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Glimepiride
Pioglitazone
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013