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

Phase 3

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

• Registration Number: NCT03641352
• 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 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 Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2018-07-20
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-22
• Last Update Posted: 2018-08-22
• Primary Completion: 2021-04-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

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

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of