Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes

Phase 3

• Conditions: Type2 Diabetes
• Interventions: Drug: CKD-501 0.5mg; Drug: Placebo

• Registration Number: NCT03627182
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2018-04-26
• Status Verified: 2018-06
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13
• Primary Completion: 2022-03-29
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-501 0.5mg	CKD-501 0.5mg	CKD-501 0.5mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)	Baseline, 24 weeks, 52 weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 52 weeks
Change from baseline in Total Cholesterol	Baseline, 24 weeks, 52 weeks
Change from baseline in Triglycerides	Baseline, 24 weeks, 52 weeks
Change from baseline in LDL-Cholesterol	Baseline, 24 weeks, 52 weeks
Change from baseline in HDL-Cholesterol	Baseline, 24 weeks, 52 weeks
Change from baseline in non-HDL-Cholesterol	Baseline, 24 weeks, 52 weeks
Change from baseline in Small Dense LDL-Cholesterol	Baseline, 24 weeks, 52 weeks
Change from baseline in FFA(Free Fatty Acid)	Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ	Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-B	Baseline, 24 weeks, 52 weeks
Change from baseline in Fasting plasma glucose	Baseline, 24 weeks, 52 weeks
Change from baseline in QUICKI(Quantitative Insulin Check Index)	Baseline, 24 weeks, 52 weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)	Baseline, 24 weeks, 52 weeks
HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)	Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ	Baseline, 24 weeks, 52 weeks
Evaluate safety of CKD-501 from number of participants with adverse events	Baseline, 24 weeks, 52 weeks

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of