Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Multinational, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group
study The study was divided into three parts: part 1 was a screening period started with an
initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during
which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25
mg bid (twice daily), or LC15-0444 50 mg qd 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 50 mg qd.
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, eligible
patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of
24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18,
and 24. Completing double-blind treatment for 24 weeks, 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 50 mg once daily. During 28-week treatment period of the part 3, each patient
visited the study
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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