NCT03770052已完成4 期
A Double Blind, Randomized, Investigator Initiated Study on Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- HbA1c at 24 week
研究概览
简要总结
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
详细描述
This study is a double blind, randomized, investigator initiated study on glucose-lowering effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg robeglitazone add-on group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type Ⅱ diabetes mellitus
- •Between 19 years and 80 years old
- •BMI between 20kg/㎡ to 45kg/㎡
- •Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3 months, A person who has not changed the dosage of Metformin 500 mg and DPP-4 inhibitor for more than 8 weeks at the time of screening
- •HbA1c 7.0 to 9.0
- •Agreement with written informed consent
排除标准
- •Historical history of severe heart failure or heart failure (NYHA Class III&IV)
- •Rapid coronary syndrome, cardiovascular interventions within 6 months
- •History of cerebral vascular diseases within six months
- •High blood pressure uncontrolled (>160/100 mmHg)
- •In case weight loss drug is used within 3 months
- •In case of systemic corticosteroids treatment within 3 months
- •If there is an allergy or overreaction to the study drug or its components
- •In case of acute metabolic complications (ketonicemia or high osmotic pressure) within 6 months
- •Anemia Hb < 12g/dL(male), 10g/dL(female)
- •Kidney function GFR < 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator).
- •impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range [ULN])
- •TG>500 mg/dL
- •LDL cholesterol >160 mg/dL
- •If a lipid-lowering agent is being taken, the existing dose should be taken during the study period.
- •The thyroid hormone is within its normal range
- •however, thyroid hormone may be registered at the discretion of the investigator even if it is outside the normal range.
- •Laser treatment for proliferative retinopathy within 6 months
- •history of alcohol or drug abuse in the previous 3 months
- •history of most cancers not in remission for 5 years
- •Past history of bladder cancer
- •Women nursing or pregnant Persons who are not using effective contraceptive methods, or who refuse to use contraceptives as specified below (permitted contraceptives: condoms, castings, or implantation contraceptives, etc.) are installed with contraceptives in the uterus
- •external injury, acute infections, a history/presence of any other severe disease, or severe trauma
- •Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials
- •A person who has used endemic insulin for more than 7 days in the last 8 weeks
- •A person with the drug usage in the TZD series over the last eight weeks.
- •When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series;
- •The researcher determines that other participants may experience difficulties in participating in the test through to the end, or that participation in the test may result in additional risks or confusion in the test results.
研究组 & 干预措施
0.25mg robeglitazone add-on group
Experimental
0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
干预措施: duvie (Drug)
0.5mg robeglitazone add-on group
Active Comparator
0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
干预措施: duvie (Drug)
结局指标
主要结局
HbA1c at 24 week
时间窗: 24 week
changes of HbA1c between baseline and 24 week
次要结局
- hs-CRP(24 week)
- AST(24 week)
- HOMA-IR(24 week)
- adiponectin(24 week)
- adverse event (weight gain,edema)(24 week)
- ALT(24 week)
- lipid levels(24 week)
- ALP(24 week)
- total bilirubin(24 week)
研究者
In Ju Kim
Professor
Pusan National University Hospital
研究点 (1)
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