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

• Status: Completed
• Trial end date: 2020-12-02
• 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

• 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