Clinical Trial Details
| Trial ID: | L3175 |
| Source ID: | NCT02480465 |
| Associated Drug: | Lobelitazone 0.5mg |
| Title: | Efficacy and Safety of Lobeglitazone Versus Sitagliptin |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Lobelitazone 0.5mg|DRUG: Sitagliptin 100mg |
| Outcome Measures: | Primary: The mean percent change of HbA1c, from baseline at 24 weeks | Secondary: The rate of Metabolic Syndrome, from baseline at 24 weeks|The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line), from baseline at 24 weeks|The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI), from baseline at 24 weeks|The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B), from baseline at 24 weeks|The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%), from baseline at 24 weeks|The mean percent change of Adiponectin, from baseline at 24 weeks|The mean percent change of hs-CRP, from baseline at 24 weeks|Safety evaluation - physical examination, vital sign, laboratory, adverse event, from baseline at 24 weeks |
| Sponsor/Collaborators: | Sponsor: Chong Kun Dang Pharmaceutical |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 248 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-01 |
| Completion Date: | 2017-03 |
| Results First Posted: | |
| Last Update Posted: | 2015-07-08 |
| Locations: | Korea University Anam Hospital, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02480465 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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