Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
Phase 4
Completed
- Conditions
- Type 2 Diabetes MellitusInsulin Resistance
- Interventions
- Registration Number
- NCT00576784
- Lead Sponsor
- IKFE Institute for Clinical Research and Development
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A pioglitazone and glimepiride pioglitazone/glimepiride
- Primary Outcome Measures
Name Time Method The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value 6 months
- Secondary Outcome Measures
Name Time Method 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 6 months
Trial Locations
- Locations (1)
IKFE
🇩🇪Mainz, Germany