Clinical trial NCT03641352: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
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 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

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

Primary outcomes:
measure: Change from baseline in Glycosylated Hemoglobin
timeFrame: Baseline, 24weeks
Secondary outcomes:
measure: Change from baseline in in Glycosylated Hemoglobin
timeFrame: Baseline, 52weekes
measure: Change from baseline in Fasting plasma glucose
timeFrame: Baseline, 24weeks, 52weeks
measure: HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)
timeFrame: Baseline, 24weeks
measure: Change from baseline in Total Cholesterol
timeFrame: Baseline, 24weeks, 52weeks
measure: Evaluate safety of CKD-501 from number of participants with adverse events
timeFrame: Baseline, 24weeks, 52weeks
measure: Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
timeFrame: Baseline, 24weeks, 52weeks
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: 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-B
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Apo-CⅢ
timeFrame: Baseline, 24 weeks, 52 weeks
measure: Change from baseline in Apo-AⅠ
timeFrame: Baseline, 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Kun ho Yoon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: