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

Chong Kun Dang

Status and phase

Completed

Phase 3

Conditions

Type2 Diabetes

Treatments

Drug: Placebo

Drug: CKD-501 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03739125

19DM16022

Details and patient eligibility

About

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.

Full 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.

Enrollment

226 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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