Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
Information source: IKFE Institute for Clinical Research and Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Insulin Resistance
Intervention: pioglitazone and glimepiride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: IKFE Institute for Clinical Research and Development
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.
Clinical Details
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 design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The proportion of patients with an increase in HbA1c by 0.5 % after 6 months
of treatment compared to baseline HbA1c value
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
IKFE, Mainz 55116, Germany
Additional Information
Starting date: April 2005
Ending date: April 2007
Last updated: December 17, 2007
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