Clinical Trial Details
| Trial ID: | L5454 |
| Source ID: | NCT01037842 |
| Associated Drug: | Mitiglinide |
| Title: | Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Mitiglinide|DRUG: Placebo |
| Outcome Measures: | Primary: the change in HbA1c from randomization to endpoint, 16 weeks after radomization | Secondary: the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline, 16 weeks after radomization |
| Sponsor/Collaborators: | Sponsor: Seoul National University Hospital | Collaborators: Seoul St. Mary's Hospital|The Catholic University of Korea|Uijeongbu St. Mary Hospital|Korea University|Kyungpook National University Hospital|Pusan National University College of Medicine|Sungkyunkwan University|Yonsei University|Eulji University|Chonnam National University|Chonbuk National University|Chungnam National University|Hallym University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 145 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2006-08 |
| Completion Date: | 2008-05 |
| Results First Posted: | |
| Last Update Posted: | 2009-12-23 |
| Locations: | Pusan National University College of Medicine, Busan, Korea, Republic of|Kyungpook National University School of Medicine, Daegu, Korea, Republic of|Chungnam National University College of Medicine, Daejeon, Korea, Republic of|Chonnam National University College of Medicine, Gwangju, Korea, Republic of|Chonbuk National University College of Medicine, Jeonju, Korea, Republic of|Eulji University School of Medicine, Seoul, Korea, Republic of|Hallym University College of Medicine, Seoul, Korea, Republic of|Korea University College of Medicine, Seoul, Korea, Republic of|Seoul St. Mary's Hospital, Seoul, Korea, Republic of|SungKyunKwan University School of Medicine, Seoul, Korea, Republic of|The Catholic University of Korea, Seoul, Korea, Republic of|Yonsei University College of Medicine, Seoul, Korea, Republic of|Uijeongbu St. Mary Hospital, Uijeongbu, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01037842 |

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