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Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

C

Chong Kun Dang

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Pioglitazone 15mg
Drug: CKD-501 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106131
19DM09F

Details and patient eligibility

About

The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Full description

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Enrollment

253 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Between 18 years and 80 years old(male or female)
  • Type Ⅱ diabetes mellitus
  • The patient who has been taking oral hypoglycemic agent since 2 months with HbA1c 7 to 10% at screening test
  • BMI between 21kg/㎡ and 40kg/㎡
  • C-peptide level is over 1.0 ng/ml
  • Agreement with written informed consent

Exclusion criteria

  • Type I diabetes or secondary diabetes
  • Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
  • Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
  • Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
  • Past history: lactic acidosis or metformin contraindication
  • Acute or chronic metabolic acidosis including diabetic ketoacidosis
  • History of proliferative diabetic retinopathy
  • Severe infection, severe injury patients (pre and post operation)
  • Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency
  • Drug abuse or history of alcoholism
  • History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
  • Fasting Plasma Glucose level is over 270 mg/dl
  • Triglyceride level is 500 mg/dl and over
  • Significant abnormal liver dysfunction: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL)
  • Significant abnormal renal dysfunction
  • Anemia
  • Abnormality of thyroid function(out of significant normal TSH range )
  • Hepatitis B or C test is positive
  • Pregnant women or nursing mothers
  • Has a contraindication to treatment
  • Fertile women who not practice contraception with appropriate methods
  • Participated in other trial within 4 weeks
  • Participating in other trial at present
  • In investigator's judgment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

253 participants in 2 patient groups

CKD-501 0.5mg
Experimental group
Treatment:
Drug: CKD-501 0.5mg
Pioglitazone 15mg
Active Comparator group
Treatment:
Drug: Pioglitazone 15mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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