The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

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

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

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

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

Contacts and Locations

• Study Contact: Name: Kun ho Yoon, Ph.D; Phone Number: 82-2-2258-6007; Email: yoonk@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Contact: kun ho yoon, Ph.D; Phone Number: 82-2-2258-6007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).
Experimental: CKD-501 0.5mg	Drug: CKD-501 0.5mg; CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759; Other Names: Lobeglitazone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in in Glycosylated Hemoglobin	Baseline, 52weekes
Change from baseline in Fasting plasma glucose	Baseline, 24weeks, 52weeks
HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)	Baseline, 24weeks
Change from baseline in Total Cholesterol	Baseline, 24weeks, 52weeks
Evaluate safety of CKD-501 from number of participants with adverse events	Baseline, 24weeks, 52weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)	Baseline, 24weeks, 52weeks
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Kun ho Yoon, Ph.D, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 19, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 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: 19DM17012

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