Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-501 0.5mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility 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
Sites / Locations
- Severance Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CKD-501 0.5mg
Placebo
Arm Description
CKD-501 0.5mg
Placebo
Outcomes
Primary Outcome Measures
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Secondary Outcome Measures
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Change from baseline in Fasting plasma glucose
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
Change from baseline in QUICKI(Quantitative Insulin Check Index)
HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)
Change from baseline in Total Cholesterol
Change from baseline in Triglycerides
Change from baseline in LDL-Cholesterol
Change from baseline in HDL-Cholesterol
Change from baseline in non-HDL-Cholesterol
Change from baseline in Small Dense LDL-Cholesterol
Change from baseline in FFA(Free Fatty Acid)
Change from baseline in Apo-AⅠ
Change from baseline in Apo-B
Change from baseline in Apo-CⅢ
Evaluate safety of CKD-501 from number of participants with adverse events
Full Information
NCT ID
NCT03627182
First Posted
July 4, 2018
Last Updated
August 10, 2018
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03627182
Brief Title
Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
March 29, 2022 (Anticipated)
Study Completion Date
February 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-501 0.5mg
Arm Type
Experimental
Arm Description
CKD-501 0.5mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CKD-501 0.5mg
Other Intervention Name(s)
Lobeglitazone 0.5mg
Intervention Description
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, 52 weeks
Title
Change from baseline in Fasting plasma glucose
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in QUICKI(Quantitative Insulin Check Index)
Time Frame
Baseline, 24 weeks, 52 weeks
Title
HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Total Cholesterol
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Triglycerides
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in LDL-Cholesterol
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in HDL-Cholesterol
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in non-HDL-Cholesterol
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Small Dense LDL-Cholesterol
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in FFA(Free Fatty Acid)
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Apo-AⅠ
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Apo-B
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Apo-CⅢ
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Evaluate safety of CKD-501 from number of participants with adverse events
Time Frame
Baseline, 24 weeks, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BongSoo Cha, Ph.D
Phone
82-2-2228-1962
Email
bscha@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BongSoo Cha, Ph.D
Organizational Affiliation
Severance Hospital, Yonsei University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BongSoo Cha, Ph.D
Phone
82-2-2228-1962
Email
bscha@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs