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
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      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
    


Intervention name(s): LC15-0444 25mg bid; LC15-0444 50mg qd; Sitagliptin 100mg qd
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.; Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.; Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment