- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739125
Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes
Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D745 10mg: Multi-center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study
Study Overview
Status
Conditions
Intervention / Treatment
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 10mg .
Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Severance Hospital, Yonsei University Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- BMI between 21kg/㎡ and 40kg/㎡
- C-peptide level is over 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 TZD within 3months or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with TZD, SGLT2, BU
- 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 or metformin contraindication
- Acute or chronic metabolic acidosis including diabetic ketoacidosis
- History of proliferative diabetic retinopathy
- Severe infection, severe injury patients, patients of pre and post operation
- 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
- Fasting Plasma Glucose level is over 270 mg/dl
- Triglyceride level is 500 mg/dl and over
- Significant abnormal liver dysfunction
- Anemia
- Abnormality of thyroid function(out of significant normal TSH range )
- eGFR 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
- Participating in other trial at present
- In investigator's judgment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
|
Experimental: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, 24 weeks
|
Baseline, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, 52 weeks
|
Baseline, 52 weeks
|
Change from baseline in Fasting plasma glucose
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in QUICKI(Quantitative Insulin Check Index)
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
HbA1c target achievement rate at 24, 52weeks(HbA1c < 6.5%, 7%)
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Total Cholesterol
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Triglycerides
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in LDL-Cholesterol
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in HDL-Cholesterol
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in non-HDL-Cholesterol
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Small Dense LDL-Cholesterol
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in FFA(Free Fatty Acid)
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Apo-AⅠ
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Apo-B
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Change from baseline in Apo-CⅢ
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Evaluate safety of CKD-501 from number of participants with adverse events
Time Frame: Baseline, 24 weeks, 52weeks
|
Baseline, 24 weeks, 52weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: BongSoo Cha, Ph.D, Severance Hospital, Yonsei University Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19DM16022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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