| Trial ID: | L1925 |
| Source ID: | NCT01106131
|
| Associated Drug: |
Ckd-501 0.5mg
|
| Title: |
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: CKD-501 0.5mg|DRUG: Pioglitazone 15mg
|
| Outcome Measures: |
Primary: Change from baseline in Glycosylated Hemoglobin (HbA1c), Baseline, 24 weeks | Secondary: Change from baseline in glycemic parameters, Baseline, 24 weeks|Change from baseline in HbA1c target achievement rate (HbA1c < 7%), Baseline, 24 weeks|Change from baseline in lipid parameters, Baseline, 24 weeks|Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events, Baseline, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Chong Kun Dang Pharmaceutical
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
253
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-05
|
| Completion Date: |
2012-11
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-15
|
| Locations: |
Kangbuk Samsung Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01106131
|
