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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: CKD-501 0.5mg
Drug: Pioglitazone 15mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 253
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-501 0.5mg 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
Active Comparator: Pioglitazone 15mg Drug: Pioglitazone 15mg
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106131

Locations
Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: SungWoo Park, M.D., Ph.D. Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01106131     History of Changes
Other Study ID Numbers: 19DM09F
Study First Received: April 16, 2010
Last Updated: February 13, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013