Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes

NCT ID: NCT03739125

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2020-12-02

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 10mg .

Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 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

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

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

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

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone

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
• BMI between 21kg/㎡ and 40kg/㎡
• C-peptide level is over 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 TZD within 3months or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with TZD, SGLT2, BU
• 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 or metformin contraindication
• Acute or chronic metabolic acidosis including diabetic ketoacidosis
• History of proliferative diabetic retinopathy
• Severe infection, severe injury patients, patients of pre and post operation
• 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
• Fasting Plasma Glucose level is over 270 mg/dl
• Triglyceride level is 500 mg/dl and over
• Significant abnormal liver dysfunction
• Anemia
• Abnormality of thyroid function(out of significant normal TSH range )
• eGFR 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
• 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: STUDY_CHAIR

Severance Hospital, Yonsei University Health System

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

Other Identifiers

19DM16022

Identifier Type: -

Identifier Source: org_study_id