The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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

Official Title
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The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D759, Randomized, Double-blind, Multi-center, Parallel-group, Placebo Control, Therapeutic Confirmatory Study

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: CKD-501 0.5mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-501 0.5mg<br>CKD-501 0.5mg | Drug: CKD-501 0.5mg<br>* CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759<br>* Other names: Lobeglitazone;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Glycosylated Hemoglobin |  | Baseline, 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in in Glycosylated Hemoglobin |  | Baseline, 52weekes | 
| 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 LDL-Cholesterol |  | Baseline, 24 weeks, 52 weeks | 
| 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 |