Overview

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