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Clinical Trial Details

Trial ID: L6213
Source ID: NCT01882907
Associated Drug: Vildagliptin
Title: Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01882907/results
Conditions: Type 2 Diabetes
Interventions: DRUG: vildagliptin|DRUG: Pioglitazone
Outcome Measures: Primary: Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group, 16 weeks | Secondary: the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups, 1. After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Fasting Plasma Glucose (FPG) 2. After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Postprandial Glucose (PPG), 16 weeks , visit 5|the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups, The Mean Changes of Lipid Profiles(Triglyceride, Total cholesterol, LDL, HDL, Non-HDL cholesterol) From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups after 16weeks, 16 weeks, visit 5|the Mean Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups, 16 weeks, visit 5|the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups, 16 weeks, visit 5 | Other: the Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups, 16 weeks, visit 3,4,5
Sponsor/Collaborators: Sponsor: Pusan National University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 287
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-12
Completion Date: 2013-03
Results First Posted: 2015-03-17
Last Update Posted: 2019-03-21
Locations: Busan Saint Mary's Medical Center, Busan, Korea, Republic of|Dong-AUniversity Medical Center, Busan, Korea, Republic of|Inje University Baik Hospital, Busan, Korea, Republic of|Kosin University Hospital, Busan, Korea, Republic of|Pusan National University Hospital, Busan, Korea, Republic of|Changwon Fatima Hospital, Changwon, Korea, Republic of|Daegu Catholic University Medical Center, Daegu, Korea, Republic of|Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of|Kyungbuk National Universtiy Hospital, Daegu, Korea, Republic of|Chonnam National University Hospital, Gwangju, Korea, Republic of|Chosun University Hospital, Gwangju, Korea, Republic of|Chonbuk National University Hospital, Jeonju, Korea, Republic of|Gyeongsang National University Hospital, Jinju, Korea, Republic of|Masan Samsung Medical Center, Masan, Korea, Republic of|Ulsan University Hospital, Ulsan, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01882907

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details
D336 Pioglitazone small molecule DB01132 Details