Clinical Trial Details
| Trial ID: | L5636 |
| Source ID: | NCT03770052 |
| Associated Drug: | Duvie |
| Title: | Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Inadequate Glucose Control |
| Interventions: | DRUG: duvie |
| Outcome Measures: | Primary: HbA1c at 24 week, changes of HbA1c between baseline and 24 week, 24 week | Secondary: HOMA-IR, changes of HOMA-IR between baseline and 24 week, 24 week|lipid levels, changes of lipid levels between baseline and 24 week, 24 week|hs-CRP, changes of hs-CRP between baseline and 24 week, 24 week|AST, changes of AST between baseline and 24 week, 24 week|adiponectin, changes of adiponectin between baseline and 24 week, 24 week|adverse event (weight gain,edema), changes of adverse event (weight gain,edema) between baseline and 24 week, 24 week|ALT, changes of ALT between baseline and 24 week, 24 week|ALP, changes of ALP between baseline and 24 week, 24 week|total bilirubin, changes of total bilirubin between baseline and 24 week, 24 week |
| Sponsor/Collaborators: | Sponsor: Pusan National University Hospital | Collaborators: Chong Kun Dang Pharmaceutical Corp. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 159 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-10-24 |
| Completion Date: | 2021-09-13 |
| Results First Posted: | |
| Last Update Posted: | 2022-01-20 |
| Locations: | Pusan National University Hospital, Busan, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT03770052 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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