An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in comparison to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

Inclusion Criteria:

• Type Ⅱ diabetes mellitus

• Between 18 years and 80 years old

• The patient who has been taking oral hypoglycemic agent since 3 months with HbA1c 6.5 to 9% at screening test or who is drug naive or stopped taking oral hypoglycemic agent more then 3 months with HbA1c 7 to 10% at screening test

• BMI between 21kg/㎡ and 40kg/㎡

• Diagnosis of type Ⅱ diabetes before 3 months

• C-peptide level is over 1.0 ng/ml

• Condition for female having contraception methods, surgical sterilization or menopause

• Condition for male agreeing to use of recommendatory and appropriate contraception method

• Agreement with written informed consent

Exclusion Criteria:

• Type I diabetes, gestational diabetes or secondary diabetes

• Treatment with insulin or thiazolidinediones within 60 days

• Fasting Plasma Glucose level is over 250 mg/dl

• Triglyceride level is 500 mg/dl and over

• Uncontrollable hypertension(Although treat with antihypertension agent, systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 90 mmHg)

• 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 2.5 times as high as upper normal limit(UNL)

• Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit

• Anemia for any reason

• Needs treatment for acute disease, uncontrolled other diseae or diabetic complications

• Abnormality of thyroid function(out of normal TSH range )

• History of proliferative diabetic retinopathy

• 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

• An impossible one who participates in clinical trial by legal or investigator's decision

• Participated in other trial within 4 weeks

• Participating in other trial at present