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BI 1356 BS Phase II in Japanese T2DM
NCT02183324Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Jun 2007
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- linagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 2, randomised, double-blind trial of linagliptin in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Boehringer Ingelheim. Primary endpoints: Global assessment of tolerability at Day 43, Number of patients with adverse events and 2 more. Started Feb 2007; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Low Dose (0.5 mg)
BI 1356 BS 0.5 mg q.d.
Medium Dose (2.5 mg)
BI 1356 BS 2.5 mg q.d.
High Dose (10 mg)
BI 1356 BS 10 mg q.d.
Placebo
Placebo q.d.
03
Who it enrols
Japanese patients with T2DM, aged 21-70, BMI 17.6-35, HbA1c <= 8.5% (or 8.0% if on 2 drugs), treated with diet/exercise or 1-2 oral agents (except glitazones). Excludes renal/cardiac insufficiency, hypertension >150/95, and recent use of long half-life drugs.
04
Endpoints
Primary
Global assessment of tolerability
Number of patients with adverse events
Clinically relevant changes in vital signs
Clinically relevant changes in clinical laboratory tests
Secondary
Maximum measured concentration of the analyte in plasma
Area under the concentration time curve
Minimum dipeptidyl peptidase IV (DPP-IV) activity
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