Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Inclusion_Criteria:
Exclusion criteria
Exclusion_Criteria:
Primary purpose
Allocation
Interventional model
Masking
333 participants in 5 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal