Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin (PIOswitch)
|Type 2 Diabetes Mellitus Insulin Resistance||Drug: pioglitazone and glimepiride||Phase 4|
|Study Design:||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|
- 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 ]
- 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 ]
|Study Start Date:||April 2005|
|Study Completion Date:||April 2007|
Active Comparator: A
Drug: pioglitazone and glimepiride
switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576784
|Mainz, Germany, 55116|