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

• Status: Recruiting
• Trial end date: 2023-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

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