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Completed

NCT Number: NCT01030679

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Inje University Medical Center, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-501 0.5mg

Drug

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

Other names: Lobeglitazone

CKD-501 1mg

Drug

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

Other names: Lobeglitazone

CKD-501 2mg

Drug

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

Other names: Lobeglitazone

Placebo

Drug

orally, 1 tablet once daily for 8 weeks

Primary outcomes

  1. Change from baseline in fasting plasma glucose at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline in Glycemic parameters after 8 weeks

    Time frame: 8 weeks

  2. Change from baseline in Lipid parameters after 8 weeks

    Time frame: 8 weeks

  3. Adverse event profile after 8 weeks of treatment

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2009
Registry last updated
Dec 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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