Clinical trial NCT03627182: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Fasting plasma glucose
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in QUICKI(Quantitative Insulin Check Index)
timeFrame: Baseline, 24 weeks, 52 weeks
measure: HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Total Cholesterol
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Triglycerides
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in LDL-Cholesterol
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in HDL-Cholesterol
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in non-HDL-Cholesterol
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Small Dense LDL-Cholesterol
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in FFA(Free Fatty Acid)
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Apo-AⅠ
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Apo-B
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Apo-CⅢ
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Evaluate safety of CKD-501 from number of participants with adverse events
timeFrame: Baseline, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: BongSoo Cha, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: