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

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01030679
First received: December 9, 2009
Last updated: December 14, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: CKD-501 0.5mg
Drug: CKD-501 1mg
Drug: CKD-501 2mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Change from baseline in fasting plasma glucose at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Glycemic parameters after 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Lipid parameters after 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse event profile after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 214
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-501 0.5mg Drug: CKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Name: Lobeglitazone
Experimental: CKD-501 1mg Drug: CKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Name: Lobeglitazone
Experimental: CKD-501 2mg Drug: CKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Name: Lobeglitazone
Placebo Comparator: Placebo Drug: Placebo
orally, 1 tablet once daily for 8 weeks
Other Name: placebo

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030679

Locations
Korea, Republic of
The Inje University Medical Center
Busan, Korea, Republic of
The Yeungnam University Hospital
Daegu, Korea, Republic of
The Seoul National Univertisy Bundang Hospital
Gyeonggi-do, Korea, Republic of
The Chtholic University of Korea Uijeongbu St. Mary's Hospital
Gyeonggi-do, Korea, Republic of
The Wonju Christian Hospital
Kangwon-Do, 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
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: Dongseop Choi, MD.,Ph.D. The Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Chin Kim/Medical Director, Chong Kun Dang
ClinicalTrials.gov Identifier: NCT01030679     History of Changes
Other Study ID Numbers: 19DM05L
Study First Received: December 9, 2009
Last Updated: December 14, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Diabetes Mellitus, type 2
Glitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013