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

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641352
• Other study ID #: 19DM17012
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: Kun ho Yoon, Ph.D
• Phone: 82-2-2258-6007
• Email: yoonk[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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
• 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).

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Glycosylated Hemoglobin		Baseline, 24weeks
Secondary	Change from baseline in in Glycosylated Hemoglobin		Baseline, 52weekes
Secondary	Change from baseline in Fasting plasma glucose		Baseline, 24weeks, 52weeks
Secondary	HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)		Baseline, 24weeks
Secondary	Change from baseline in Total Cholesterol		Baseline, 24weeks, 52weeks
Secondary	Evaluate safety of CKD-501 from number of participants with adverse events		Baseline, 24weeks, 52weeks
Secondary	Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)		Baseline, 24weeks, 52weeks
Secondary	Change from baseline in HOMA-ß(Homeostasis Model Assessment of ß-cell function)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in QUICKI(Quantitative Insulin Check Index)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Triglycerides		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in LDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in HDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in non-HDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Small Dense LDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in FFA(Free Fatty Acid)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-B		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-C?		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-A?		Baseline, 24 weeks, 52 weeks