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Clinical Trial Details

Trial ID: L2350
Source ID: NCT01805830
Associated Drug: Mp513
Title: Teneligliptin(MP-513) vs. Placebo in Patient With Metformin Monotherapy
Acronym: T2DM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: MP513|DRUG: Placebo
Outcome Measures: Primary: HbA1c, Change from Visit 1(Baseline Visit) in HbA1c at Visit 5(week 16) | Secondary: FPG(Fasting Plasma Glucose), Change from Visit 1(Baseline Visit) in FPG at Visit 5(week 16)|Weight, Change from Visit 1(Baseline Visit) in weight at Visit 5(week 16)|BMI, Change from Visit 1(Baseline Visit) in BMI at Visit 5(week 16)|HbA1c <7.0%, The proportion of patients who achieve an HbA1c<7.0% at Visit 5(week 16)|HbA1c <6.5%, The proportion of patients who achieve an HbA1c<6.5% at Visit 5(week 16)|Total Cholesterol, Change from Visit 1(Baseline Visit) in Total Cholesterol at Visit 5(week 16)|LDL Cholesterol, Change from Visit 1(Baseline Visit) in LDL Cholesterol at Visit 5(week 16)|HDL Cholesterol, Change from Visit 1(Baseline Visit) in HDL Cholesterol at Visit 5(week 16)|Triglyceride, Change from Visit 1(Baseline Visit) in Triglyceride at Visit 5(week 16)|C-peptide, Change from Visit 1(Baseline Visit) in C-peptide at Visit 5(week 16)|Insulin, Change from Visit 1(Baseline Visit) in insulin at Visit 5(week 16)|hsCRP, Change from Visit 1(Baseline Visit) in hsCRP at Visit 5(week 16)|HOMA-β, Change from Visit 1(Baseline Visit) in HOMA-β at Visit 5(week 16)|HOMA-IR, Change from Visit 1(Baseline Visit) in HOMA-IR at Visit 5(week 16)
Sponsor/Collaborators: Sponsor: Handok Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 189
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-05
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2015-10-06
Locations: Handok Pharmaceuticals CO. LTD, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01805830