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

NCT ID: NCT03627182

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2023-02-10

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 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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CKD-501 0.5mg

CKD-501 0.5mg

Group Type: EXPERIMENTAL

CKD-501 0.5mg

Intervention Type: DRUG

CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

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

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone 0.5mg

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BongSoo Cha, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University Health System

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

BongSoo Cha, Ph.D

Role: CONTACT

bscha@yuhs.ac

82-2-2228-1962

Facility Contacts

BongSoo Cha, Ph.D

Role: primary

bscha@yuhs.ac

82-2-2228-1962

Other Identifiers

19DM17015

Identifier Type: -

Identifier Source: org_study_id