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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

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