| Trial ID: | L5152 |
| Source ID: | NCT01602003
|
| Associated Drug: |
Lc15-0444 25mg Bid
|
| Title: |
Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: LC15-0444 25mg bid|DRUG: LC15-0444 50mg qd|DRUG: Sitagliptin 100mg qd
|
| Outcome Measures: |
Primary: Change of HbAlc, from baseline to Week 24 | Secondary: HbA1c Responder Rate, responder rate of HbA1c \<7%, \<6.5% at week 24, at Week 24
|
| Sponsor/Collaborators: |
Sponsor: LG Life Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
425
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-12
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2012-05-18
|
| Locations: |
LG Life Sciences, Seoul, 110-062, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01602003
|
