Insulin Resistance, Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes, insulin treatment, ß-cell function
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).
Interventions
switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
Sponsors
IKFE Institute for Clinical Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed