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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

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: CKD-501 0.5mg Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : March 29, 2022
Estimated Study Completion Date : February 10, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CKD-501 0.5mg
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 D150 and D745
Other Name: Lobeglitazone 0.5mg

Placebo Comparator: Placebo
Placebo
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).





Primary Outcome Measures :
  1. Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ]
  2. Change from baseline in Fasting plasma glucose [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  3. Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  4. Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  5. Change from baseline in QUICKI(Quantitative Insulin Check Index) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  6. HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  7. Change from baseline in Total Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  8. Change from baseline in Triglycerides [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  9. Change from baseline in LDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  10. Change from baseline in HDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  11. Change from baseline in non-HDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  12. Change from baseline in Small Dense LDL-Cholesterol [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  13. Change from baseline in FFA(Free Fatty Acid) [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  14. Change from baseline in Apo-AⅠ [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  15. Change from baseline in Apo-B [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  16. Change from baseline in Apo-CⅢ [ Time Frame: Baseline, 24 weeks, 52 weeks ]
  17. Evaluate safety of CKD-501 from number of participants with adverse events [ Time Frame: Baseline, 24 weeks, 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627182


Contacts
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Contact: BongSoo Cha, Ph.D 82-2-2228-1962 bscha@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: BongSoo Cha, Ph.D    82-2-2228-1962    bscha@yuhs.ac   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: BongSoo Cha, Ph.D Severance Hospital, Yonsei University Health System
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03627182    
Other Study ID Numbers: 19DM17015
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases