Type2 Diabetes
Conditions
Brief summary
The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
Detailed description
The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
Interventions
DRUGCKD-501 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759
DRUGPlacebo
Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* between 19 years and 80 years old(male or female) * Type 2 diabetes mellitus * The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test * BMI between 21kg/m2 and 40kg/m2 * C-peptide ≥ 1.0 ng/ml * Agreement with written informed consent * HbA1c 7 to 10% after Run-in period
Exclusion criteria
* Type 1 diabetes mellitus or secondary diabetes mellitus * Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening * Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide * Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening * Treatment with anti-obesity drugs within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Glycosylated Hemoglobin | Baseline, 24weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Fasting plasma glucose | Baseline, 24weeks, 52weeks |
| HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%) | Baseline, 24weeks |
| Change from baseline in Total Cholesterol | Baseline, 24weeks, 52weeks |
| Evaluate safety of CKD-501 from number of participants with adverse events | Baseline, 24weeks, 52weeks |
| Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance) | Baseline, 24weeks, 52weeks |
| Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in QUICKI(Quantitative Insulin Check Index) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Triglycerides | Baseline, 24 weeks, 52 weeks |
| Change from baseline in in Glycosylated Hemoglobin | Baseline, 52weekes |
| Change from baseline in HDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in non-HDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Small Dense LDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in FFA(Free Fatty Acid) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-B | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-CⅢ | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-AⅠ | Baseline, 24 weeks, 52 weeks |
| Change from baseline in LDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
Countries
South Korea
Contacts
Primary ContactKun ho Yoon, Ph.D
Outcome results
None listed