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

Chong Kun Dang Pharmaceutical240 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Type2 Diabetes

Interventions

CKD-501 0.5mgDRUG

CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759

PlaceboDRUG

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).

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in Glycosylated Hemoglobin

Time frame: Baseline, 24weeks

Secondary Outcomes

Change from baseline in in Glycosylated Hemoglobin

Time frame: Baseline, 52weekes

Change from baseline in Fasting plasma glucose

Time frame: Baseline, 24weeks, 52weeks

HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)

Time frame: Baseline, 24weeks

Change from baseline in Total Cholesterol

Time frame: Baseline, 24weeks, 52weeks

Evaluate safety of CKD-501 from number of participants with adverse events

Time frame: Baseline, 24weeks, 52weeks

Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)

Time frame: Baseline, 24weeks, 52weeks

Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)

Time frame: Baseline, 24 weeks, 52 weeks

Change from baseline in QUICKI(Quantitative Insulin Check Index)

Time frame: Baseline, 24 weeks, 52 weeks

Change from baseline in Triglycerides

Time frame: Baseline, 24 weeks, 52 weeks

Change from baseline in LDL-Cholesterol

Central Contacts

Kun ho Yoon, Ph.D

CONTACT

82-2-2258-6007 yoonk@catholic.ac.kr

Data from ClinicalTrials.gov

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