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

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: CKD-501 1mg; Drug: CKD-501 0.5mg; Drug: Placebo; Drug: CKD-501 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030679

19DM05L

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 4 patient groups, including a placebo group

CKD-501 0.5mg

Experimental group

Treatment:

Drug: CKD-501 0.5mg

CKD-501 1mg

Experimental group

Treatment:

Drug: CKD-501 1mg

CKD-501 2mg

Experimental group

Treatment:

Drug: CKD-501 2mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo