A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and
tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2
diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose
will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid
for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability,
pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study
treatment is <3 months, and the target sample size is <100 individuals.