Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group
study The study was divided into three parts: part 1 was started with an initial 2 weeks of
exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part
2 was a double-blind treatment period during which eligible patients were randomized to
LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was
for those patients who completed part 1 & 2 and consented to receive another 28 weeks of
treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given
the written informed consent. After 2-week exercise/diet program according to the generally
recognized guideline, patients took placebo for another 2 weeks while continuing
exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients
were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24-
week treatment period of part 2 after randomization, each patient visited the investigational
site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24
weeks after randomization, each patient was asked to provide consent to participate in the
part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the
treatment received during the part 2 of the study. During 28-week treatment period of the
part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study
period from screening was 56 weeks per each patient.