Clinical Trial Details
| Trial ID: | L4781 |
| Source ID: | NCT02512523 |
| Associated Drug: | Teneligliptin |
| Title: | Exploratory Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin (CGMS Study) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Teneligliptin|DRUG: Sitagliptin |
| Outcome Measures: | Primary: Mean amplitude of glucose excursion (MAGE), Change in mean amplitude of glucose excursion (MAGE) from baseline at 4 weeks, 4 weeks | Secondary: Standard deviation (SD), Change in standard deviation (SD) from baseline at 4 weeks, 4 weeks|Mean blood glucose (MBG), Change in mean blood glucose (MBG) from baseline at 4 weeks, 4 weeks|Mixed meal tolerance test (MMTT), Change in Mixed meal tolerance test (MMTT) parameters including glucose, GLP-1, insulin, C-peptide, glucagon, HOMA-IR, HOMA-b from baseline at 4 weeks, 4 weeks|Safety (All AE including SAE, hypoglycemia, laboratory tests, vital sign, and physical examination), All AE including SAE, hypoglycemia, laboratory tests, vital sign, and physical examination, 4 weeks |
| Sponsor/Collaborators: | Sponsor: Handok Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 39 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-08-27 |
| Completion Date: | 2016-09-26 |
| Results First Posted: | |
| Last Update Posted: | 2025-01-27 |
| Locations: | HANDOK Inc., Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02512523 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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