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

C

Chong Kun Dang

Status and phase

Completed
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: CKD-501 1mg
Drug: CKD-501 0.5mg
Drug: Placebo
Drug: CKD-501 2mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030679
19DM05L

Details and patient eligibility

About

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.

Enrollment

214 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

214 participants in 4 patient groups, including a placebo group

CKD-501 0.5mg
Experimental group
Treatment:
Drug: CKD-501 0.5mg
CKD-501 1mg
Experimental group
Treatment:
Drug: CKD-501 1mg
CKD-501 2mg
Experimental group
Treatment:
Drug: CKD-501 2mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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