| Trial ID: | L4640 |
| Source ID: | NCT04014023
|
| Associated Drug: |
Dwp16001
|
| Title: |
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: DWP16001|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, at 12 weeks | Secondary: Change from baseline in FPG, at week 4, 8, 12|The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline, at week 4, 8, 12
|
| Sponsor/Collaborators: |
Sponsor: Daewoong Pharmaceutical Co. LTD.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
196
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-07-10
|
| Completion Date: |
2020-06
|
| Results First Posted: |
|
| Last Update Posted: |
2019-07-18
|
| Locations: |
Daewoong pharmatceutical, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04014023
|
