Trial | NCT01030679  Report issue

Title

Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus
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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lobeglitazone ...

  • Study Participants

    214
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.
Study Started
Jul 31
2007
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Dec 16
2009
Estimate

Drug CKD-501 0.5mg

0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks

  • Other names: Lobeglitazone

Drug CKD-501 1mg

1 mg/tablet, orally, 1 tablet once daily for 8 weeks

  • Other names: Lobeglitazone

Drug CKD-501 2mg

2 mg/tablet, orally, 1 tablet once daily for 8 weeks

  • Other names: Lobeglitazone

Drug Placebo

orally, 1 tablet once daily for 8 weeks

CKD-501 1mg Experimental

CKD-501 2mg Experimental

Placebo Placebo Comparator

CKD-501 0.5mg Experimental

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
No Results Posted