| Trial ID: | L6617 |
| Source ID: | NCT01001611
|
| Associated Drug: |
Ckd-501 0.5mg
|
| Title: |
An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: CKD-501 0.5mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in Glycosylated Hemoglobin (HbA1c), 24 weeks | Secondary: Change from baseline in HbA1c target achievement rate (HbA1c<7%), 24 weeks|Change from baseline in lipid parameters (Total cholesterol, Triglycerides(TG), LDL-C, HDL-C, Small Dense LDL-C, Free fatty acid(FFA), Apo-AⅠ/B/C Ⅲ), 24 weeks|Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on, 24 weeks or 52 weeks|Change from baseline in glycemic parameters (Fasting Plasma Glucose, C-peptide, Homeostasis Model Assessment of Insulin Resistance(HOMA-IR), Homeostasis Model Assessment of β-cell function(HOMA-β), Quantitative Insulin Check Index(QUICKI)), 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Chong Kun Dang Pharmaceutical
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
173
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-10
|
| Completion Date: |
2012-01
|
| Results First Posted: |
|
| Last Update Posted: |
2013-07-19
|
| Locations: |
The Inje University Busan-Paik Hospital, Busan, Korea, Republic of|Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea, Republic of|The Hanyang University Medical Center, Gyeonggi-do, Korea, Republic of|Wonju Severance Christian Hospital, Kangwon-Do, Korea, Republic of|The Hallym University Medical Center, Seoul, Korea, Republic of|The Inje University Sanggye-Paik Hospital, Seoul, Korea, Republic of|The Korea University Anam Hospital, Seoul, Korea, Republic of|The Kyung Hee University Medical Center, Seoul, Korea, Republic of|The Seoul National University Bundang Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01001611
|
