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

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

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 ]

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 ]

Enrollment: 100
Study Start Date: April 2005
Study Completion Date: April 2007
Arms Assigned Interventions
Active Comparator: A
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).


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

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
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Please refer to this study by its identifier: NCT00576784

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

Responsible Party: Prof. Thomas Forst, IKFE Identifier: NCT00576784     History of Changes
Other Study ID Numbers: ATS-K-013
Study First Received: December 17, 2007
Last Updated: December 17, 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
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors processed this record on May 25, 2017