Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin - Full Text View

Sponsor:	IKFE Institute for Clinical Research and Development
Information provided by:	IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:	NCT00576784

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Glimepiride Pioglitazone Pioglitazone hydrochloride

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 February 09, 2012