Clinical trial NCT01030679: Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus
Official title: To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, type 2
Glitazone
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 214
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in fasting plasma glucose at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in Glycemic parameters after 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in Lipid parameters after 8 weeks
timeFrame: 8 weeks
measure: Adverse event profile after 8 weeks of treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: The Inje University Medical Center
city: Daegu
country: Korea, Republic of
facility: The Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Chtholic University of Korea Uijeongbu St. Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Seoul National Univertisy Bundang Hospital
city: Kangwon-Do
country: Korea, Republic of
facility: The Wonju Christian Hospital
city: Seoul
country: Korea, Republic of
facility: The Inje University Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Samsung Medical Center
Study officials:
affiliation: The Korea University Anam Hospital
name: Dongseop Choi, MD.,Ph.D.
role: STUDY_CHAIR
References: