Status:
COMPLETED
An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 place...
Detailed Description
Diabetes Mellitus is classified into type 1 diabetes and type 2 diabetes mellitus according to the causes of diabetes onset and the treatment of symptoms. In type 2 diabetes, the combination of insul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01001611
Start Date
October 1 2009
End Date
January 1 2012
Last Update
July 19 2013
Active Locations (9)
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1
The Inje University Busan-Paik Hospital
Busan, South Korea
2
Soon Chun Hyang University Cheonan Hospital
Cheonan, South Korea
3
The Hanyang University Medical Center
Gyeonggi-do, South Korea
4
Wonju Severance Christian Hospital
Kangwon-Do, South Korea