The Efficacy and Safety of CKD-501 Added to D150 Plus D759 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 80 years old(male or female)
- Type 2 diabetes mellitus
- The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- BMI between 21kg/m2 and 40kg/m2
- C-peptide ≥ 1.0 ng/ml
- Agreement with written informed consent
- HbA1c 7 to 10% after Run-in period
Exclusion Criteria:
- Type 1 diabetes mellitus or secondary diabetes mellitus
- Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Treatment with anti-obesity drugs within 3 months
Sites / Locations
- The Catholic University of Korea, Seoul ST. Mary's HospitalRecruiting
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
Secondary Outcome Measures
Change from baseline in in Glycosylated Hemoglobin
Change from baseline in Fasting plasma glucose
HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)
Change from baseline in Total Cholesterol
Evaluate safety of CKD-501 from number of participants with adverse events
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)
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-B
Change from baseline in Apo-CⅢ
Change from baseline in Apo-AⅠ
Full Information
NCT ID
NCT03641352
First Posted
July 20, 2018
Last Updated
August 19, 2018
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03641352
Brief Title
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes
Official Title
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D759, Randomized, Double-blind, Multi-center, Parallel-group, Placebo Control, Therapeutic Confirmatory Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
November 30, 2022 (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 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
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
Intervention Description
CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).
Primary Outcome Measure Information:
Title
Change from baseline in Glycosylated Hemoglobin
Time Frame
Baseline, 24weeks
Secondary Outcome Measure Information:
Title
Change from baseline in in Glycosylated Hemoglobin
Time Frame
Baseline, 52weekes
Title
Change from baseline in Fasting plasma glucose
Time Frame
Baseline, 24weeks, 52weeks
Title
HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)
Time Frame
Baseline, 24weeks
Title
Change from baseline in Total Cholesterol
Time Frame
Baseline, 24weeks, 52weeks
Title
Evaluate safety of CKD-501 from number of participants with adverse events
Time Frame
Baseline, 24weeks, 52weeks
Title
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Time Frame
Baseline, 24weeks, 52weeks
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
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-B
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Apo-CⅢ
Time Frame
Baseline, 24 weeks, 52 weeks
Title
Change from baseline in Apo-AⅠ
Time Frame
Baseline, 24 weeks, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between 19 years and 80 years old(male or female)
Type 2 diabetes mellitus
The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
BMI between 21kg/m2 and 40kg/m2
C-peptide ≥ 1.0 ng/ml
Agreement with written informed consent
HbA1c 7 to 10% after Run-in period
Exclusion Criteria:
Type 1 diabetes mellitus or secondary diabetes mellitus
Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
Treatment with anti-obesity drugs within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun ho Yoon, Ph.D
Phone
82-2-2258-6007
Email
yoonk@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun ho Yoon, Ph.D
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kun ho yoon, Ph.D
Phone
82-2-2258-6007
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes
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