Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

Chong Kun Dang

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Pioglitazone 15mg

Drug: CKD-501 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106131

19DM09F

Details and patient eligibility

About

The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Full description

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Enrollment

253 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Between 18 years and 80 years old(male or female)
Type Ⅱ diabetes mellitus
The patient who has been taking oral hypoglycemic agent since 2 months 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

Exclusion criteria

Type I diabetes or secondary diabetes
Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
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 (pre and post operation)
Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency
Drug abuse or history of alcoholism
History of myocardial infarction, heart failure, cerebral infarction, hematencephalon 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: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL)
Significant abnormal renal dysfunction
Anemia
Abnormality of thyroid function(out of significant normal TSH range )
Hepatitis B or C test is positive
Pregnant women or nursing mothers
Has a contraindication to treatment
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