NCT01106131已完成3 期
Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Change from baseline in Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
CKD-501 0.5mg
Experimental
干预措施: CKD-501 0.5mg (Drug)
Pioglitazone 15mg
Active Comparator
干预措施: Pioglitazone 15mg (Drug)
结局指标
主要结局
Change from baseline in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline, 24 weeks
次要结局
- 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)
研究者
研究点 (1)
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