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Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627182
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE July 4, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date August 13, 2018
Actual Study Start Date  ICMJE April 26, 2018
Estimated Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ]
  • Change from baseline in Fasting plasma glucose [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in QUICKI(Quantitative Insulin Check Index) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Total Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Triglycerides [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in LDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in HDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in non-HDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Small Dense LDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in FFA(Free Fatty Acid) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Apo-AⅠ [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Apo-B [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Change from baseline in Apo-CⅢ [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  • Evaluate safety of CKD-501 from number of participants with adverse events [ Time Frame: Baseline, 24 weeks, 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
Official Title  ICMJE Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D745 25mg: Multi-center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study.
Brief Summary The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
Detailed Description

The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 25mg .

Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of actual drug as an oral hypoglycemic agent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • Drug: CKD-501 0.5mg
    CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
    Other Name: Lobeglitazone 0.5mg
  • Drug: Placebo

    Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745.

    CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study).

Study Arms  ICMJE
  • Experimental: CKD-501 0.5mg
    CKD-501 0.5mg
    Intervention: Drug: CKD-501 0.5mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2023
Estimated Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 19 years and 75 years old(male or female)
  • Type Ⅱ diabetes mellitus
  • The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
  • Body Mass Index between 21kg/㎡ and 40kg/㎡
  • C-peptide > 1.0 ng/ml
  • Agreement with written informed consent
  • HbA1c 7 to 10% after Run-in period

Exclusion Criteria:

  • Type I diabetes or secondary diabetes
  • Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
  • Treatment with Thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with Thiazolidinedione(TZD), sodium glucose cotransporter 2(SGLT2) inhibitor, Biguanide.
  • Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
  • Treatment with anti-obesity drugs within 3months
  • Past history: lactic acidosis, genetic problem such as galactose intolerance, etc.
  • Acute or chronic metabolic acidosis including diabetic ketoacidosis
  • History of proliferative diabetic retinopathy
  • Patient with severe infection, severe injury
  • Patients with urinary tract infection including urinary tract sepsis and pyelonephritis
  • Malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency
  • History of malignant tumor within 5years
  • Drug abuse or history of alcoholism
  • Severe pulmonary dysfunction
  • Severe GI disorder
  • History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months
  • Abnormal lab result: ① Fasting Plasma Glucose > 270 mg/dl ② Triglyceride ≥ 500 mg/dl ③ Significant liver dysfunction or AST(Aspartate transaminase)/ALT(Alanine transaminase) ≥ normal range*3 or Total bilirubin ≥ normal range*2 ④ Hemoglobin<10.5g/dL ⑤ Abnormality of thyroid function(significantly out of normal TSH(Thyroid Stimulating Hormone) range)
  • eGFR(Estimated glomerular filtration rate) is less than 60ml/min/1.73m^2
  • Pregnant women or nursing mothers
  • Fertile women who not practice contraception with appropriate methods
  • Participated in other trial within 4 weeks or participating in other trial at present
  • In investigator's judgment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BongSoo Cha, Ph.D 82-2-2228-1962 bscha@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627182
Other Study ID Numbers  ICMJE 19DM17015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: BongSoo Cha, Ph.D Severance Hospital, Yonsei University Health System
PRS Account Chong Kun Dang Pharmaceutical
Verification Date June 2018

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