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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01106131
First received: April 16, 2010
Last updated: February 13, 2013
Last verified: February 2013

April 16, 2010
February 13, 2013
May 2010
April 2012   (final data collection date for primary outcome measure)
Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106131 on ClinicalTrials.gov Archive Site
  • Change from baseline in glycemic parameters [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c target achievement rate (HbA1c < 7%) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in lipid parameters [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: CKD-501 0.5mg
    CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
    Other Name: Lobeglitazone
  • Drug: Pioglitazone 15mg
    Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
  • Experimental: CKD-501 0.5mg
    Intervention: Drug: CKD-501 0.5mg
  • Active Comparator: Pioglitazone 15mg
    Intervention: Drug: Pioglitazone 15mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
November 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01106131
19DM09F
Yes
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Not Provided
Study Chair: SungWoo Park, M.D., Ph.D. Kangbuk Samsung Hospital
Chong Kun Dang Pharmaceutical
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP