Overview

Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IKFE Institute for Clinical Research and Development
Treatments:
Glimepiride
Insulin
Insulin, Globin Zinc
Pioglitazone
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)