Clinical Trial Details
| Trial ID: | L4237 |
| Source ID: | NCT01529541 |
| Associated Drug: | Anagliptin |
| Title: | Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone |
| Acronym: | CWP-DIANA-302 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Anagliptin|DRUG: Sitagliptin |
| Outcome Measures: | Primary: The Change in HbA1c from baseline to week24., 0wk, 8wk, 16wk, 24wk | Secondary: The proportion of subjects achieving HbA1c<7% at week24, 0wk, 8wk, 16wk, 24wk|The proportion of subjects achieving HbA1c<6.5% at week24, 0wk, 8wk, 16wk, 24wk|The change from baseline to week 24: Fasting plasma glucose, 0wk, 24wk|change from baseline to week 24: Fasting serum insulin, 0wk, 24 wk|change from baseline to week 24 in Fasting serum pro-insulin, 0wk, 24wk|change from baseline to week 24 in Fasting serum c-peptide, 0wk, 24wk|change from baseline to week 24 in HOMA-β, 0wk, 24 wk|change from baseline to week 24 in HOMA-IR, 0wk, 24 wk |
| Sponsor/Collaborators: | Sponsor: JW Pharmaceutical |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 200 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-05 |
| Completion Date: | 2013-10 |
| Results First Posted: | |
| Last Update Posted: | 2014-05-14 |
| Locations: | Kangbuk Samsung Hospital, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01529541 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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