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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: CKD-501 0.5mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BongSoo Cha, Ph.D; Phone Number: 82-2-2228-1962; Email: bscha@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Contact: BongSoo Cha, Ph.D; Phone Number: 82-2-2228-1962; Email: bscha@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745. CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study).
Experimental: CKD-501 0.5mg	Drug: 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: Lobeglitazone 0.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)	Baseline, 24 weeks, 52 weeks
Change from baseline in QUICKI(Quantitative Insulin Check Index)	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-B	Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ	Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ	Baseline, 24 weeks, 52 weeks
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 52 weeks
Change from baseline in Fasting plasma glucose	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 Total Cholesterol	Baseline, 24 weeks, 52 weeks
Evaluate safety of CKD-501 from number of participants with adverse events	Baseline, 24 weeks, 52 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: BongSoo Cha, Ph.D, Severance Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Anticipated): March 29, 2022
• Study Completion (Anticipated): February 10, 2023

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19DM17015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No