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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Metformin; Pioglitazone

Criteria

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