Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, type 2, Glitazone
Brief 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.
Interventions
DRUGCKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
DRUGCKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
DRUGCKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
DRUGPlacebo
orally, 1 tablet once daily for 8 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose at 8 weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Glycemic parameters after 8 weeks | 8 weeks |
| Change from baseline in Lipid parameters after 8 weeks | 8 weeks |
| Adverse event profile after 8 weeks of treatment | 8 weeks |
Countries
South Korea
Outcome results
None listed