An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in comparison to placebo.

Detailed Description
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Diabetes Mellitus is classified into type 1 diabetes and type 2 diabetes mellitus according to the causes of diabetes onset and the treatment of symptoms. In type 2 diabetes, the combination of insulin resistance and insulin deficiency is working. Diabetes mellitus causing many complications and hospitalization is one of chronic metabolic disorder and diabetes mortality rate has been gradually increasing percentage. CKD-501 is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that CKD-501 improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 once daily for 24 weeks as a monotherapy in type 2 diabetes mellitus. Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Official Title
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An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus: A 24-week, Multi Center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study

Conditions
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Diabetes Mellitus, Type 2

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: Type Ⅱ diabetes mellitus Between 18 years and 80 years old The patient who has been taking oral hypoglycemic agent since 3 months with HbA1c 6.5 to 9% at screening test or who is drug naive or stopped taking oral hypoglycemic agent more then 3 months with HbA1c 7 to 10% at screening test BMI between 21kg/㎡ and 40kg/㎡ Diagnosis of type Ⅱ diabetes before 3 months C-peptide level is over 1.0 ng/ml Condition for female having contraception methods, surgical sterilization or menopause Condition for male agreeing to use of recommendatory and appropriate contraception method Agreement with written informed consent Exclusion Criteria: Type I diabetes, gestational diabetes or secondary diabetes Treatment with insulin or thiazolidinediones within 60 days Fasting Plasma Glucose level is over 250 mg/dl Triglyceride level is 500 mg/dl and over Uncontrollable hypertension(Although treat with antihypertension agent, systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 90 mmHg) History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 2.5 times as high as upper normal limit(UNL) Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit Anemia for any reason Needs treatment for acute disease, uncontrolled other diseae or diabetic complications Abnormality of thyroid function(out of normal TSH range ) History of proliferative diabetic retinopathy In treatment concomitant drug having severe risk drug interaction with investigational drug History of cancer within 5 years History of drug abuse or alcoholism Hepatitis B Antigen(HBsAg) test is positive Treatment systemic or inhalant corticosteroids within 1 month prior to Screening Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers Has a contraindication to treatment investigational drug from the medical and psychogenic side An impossible one who participates in clinical trial by legal or investigator's decision Participated in other trial within 4 weeks Participating in other trial at present

Ages Eligible for Study
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Minimum Age: 18 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> | Drug: CKD-501 0.5mg<br>* 0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)<br>* Other names: Lobeglitazone;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks<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 (HbA1c) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, glitazone, Type II Diabetes, Hypolipidemic, oral hypoglycemic agent