Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.

Official Title
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To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: CKD-501 0.5mg
* Drug: CKD-501 1mg
* Drug: CKD-501 2mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type Ⅱ diabetes mellitus Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270 HbA1c between 7 and 11% Body mass index (BMI) in the range 21-40 The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month Agreement with written informed consent Exclusion Criteria: Type I diabetes, gestational diabetes or secondary diabetes Treatment with insulin(over 1month) within 3 months Fasting Plasma Glucose level is over 270 mg/dl Triglyceride level is 500 mg/dl and over Uncontrollable hypertension 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 3 times as high as upper normal limit(UNL) Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit Needs treatment for acute disease, uncontrolled other diseae or diabetic complications 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 Participated in other trial within 4 weeks Participating in other trial at present An impossible one who participates in clinical trial by legal or investigator's decision

Ages Eligible for Study
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Minimum Age: 19 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: Quadruple


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 8 weeks<br>* Other names: Lobeglitazone;|
| Experimental: CKD-501 1mg<br> | Drug: CKD-501 1mg<br>* 1 mg/tablet, orally, 1 tablet once daily for 8 weeks<br>* Other names: Lobeglitazone;|
| Experimental: CKD-501 2mg<br> | Drug: CKD-501 2mg<br>* 2 mg/tablet, orally, 1 tablet once daily for 8 weeks<br>* Other names: Lobeglitazone;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* orally, 1 tablet once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Glycemic parameters after 8 weeks |  | 8 weeks | 
| Change from baseline in Lipid parameters after 8 weeks |  | 8 weeks | 
| Adverse event profile after 8 weeks of treatment |  | 8 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