Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

Study Overview
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Brief Summary
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The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Detailed Description
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The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Official Title
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Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-501 0.5mg
* Drug: Pioglitazone 15mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 years and 80 years old(male or female) Type Ⅱ diabetes mellitus The patient who has been taking oral hypoglycemic agent since 2 months with HbA1c 7 to 10% at screening test BMI between 21kg/㎡ and 40kg/㎡ C-peptide level is over 1.0 ng/ml Agreement with written informed consent Exclusion Criteria: Type I diabetes or secondary diabetes Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening Past history: lactic acidosis or metformin contraindication Acute or chronic metabolic acidosis including diabetic ketoacidosis History of proliferative diabetic retinopathy Severe infection, severe injury patients (pre and post operation) Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency Drug abuse or history of alcoholism History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months Fasting Plasma Glucose level is over 270 mg/dl Triglyceride level is 500 mg/dl and over Significant abnormal liver dysfunction: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL) Significant abnormal renal dysfunction Anemia Abnormality of thyroid function(out of significant normal TSH range ) Hepatitis B or C test is positive Pregnant women or nursing mothers Has a contraindication to treatment Fertile women who not practice contraception with appropriate methods Participated in other trial within 4 weeks Participating in other trial at present In investigator's judgment

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>* CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.<br>* Other names: Lobeglitazone;|
| Active Comparator: Pioglitazone 15mg<br> | Drug: Pioglitazone 15mg<br>* Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.<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) |  | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glycemic parameters |  | Baseline, 24 weeks | 
| Change from baseline in HbA1c target achievement rate (HbA1c < 7%) |  | Baseline, 24 weeks | 
| Change from baseline in lipid parameters |  | Baseline, 24 weeks | 
| Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events |  | Baseline, 24 weeks |