Type 2 Diabetes Mellitus
Conditions
Brief 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.
Detailed 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.
Interventions
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
DRUGCKD-501 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in glycemic parameters | Baseline, 24 weeks |
| Change from baseline in HbA1c target achievement rate (HbA1c < 7%) | Baseline, 24 weeks |
| Change from baseline in lipid parameters | Baseline, 24 weeks |
| Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events | Baseline, 24 weeks |
Countries
South Korea
Outcome results
None listed