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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: CKD-501 0.5mg; Drug: Placebo; Drug: CKD-501 2mg; Drug: CKD-501 1mg

• Registration Number: NCT01030679
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-501 0.5mg	CKD-501 0.5mg	-
Placebo	Placebo	-
CKD-501 2mg	CKD-501 2mg	-
CKD-501 1mg	CKD-501 1mg	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose at 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

The Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of

The Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

The Inje University Medical Center; 🇰🇷 Busan, Korea, Republic of

The Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Seoul National Univertisy Bundang 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 Chtholic University of Korea Uijeongbu St. Mary's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of