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.

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: CKD-501 0.5mg; Drug: CKD-501 1mg; Drug: CKD-501 2mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • The Inje University Medical Center
  • Daegu, Korea, Republic of
    • The Yeungnam University Hospital
  • Gyeonggi-do, Korea, Republic of
    • The Chtholic University of Korea Uijeongbu St. Mary's Hospital
  • Gyeonggi-do, Korea, Republic of
    • The Seoul National Univertisy Bundang Hospital
  • Kangwon-Do, Korea, Republic of
    • The Wonju Christian Hospital
  • Seoul, Korea, Republic of
    • The Inje University Sanggye-Paik Hospital
  • Seoul, Korea, Republic of
    • The Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; orally, 1 tablet once daily for 8 weeks
Experimental: CKD-501 0.5mg	Drug: CKD-501 0.5mg; 0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks; Other Names: Lobeglitazone
Experimental: CKD-501 1mg	Drug: CKD-501 1mg; 1 mg/tablet, orally, 1 tablet once daily for 8 weeks; Other Names: Lobeglitazone
Experimental: CKD-501 2mg	Drug: CKD-501 2mg; 2 mg/tablet, orally, 1 tablet once daily for 8 weeks; Other Names: Lobeglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in fasting plasma glucose at 8 weeks	8 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Dongseop Choi, MD.,Ph.D., The Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2009
• Last Update Submitted That Met QC Criteria: December 14, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, type 2; Glitazone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19DM05L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No