KCT0006731已完成未知
A Multicenter, Prospective, Randomized, Open-label, Parallel-group, Phase 4 Study to Compare the Efficacy and Safety of Triple Combination Therapy in Korean Patients with Type 2 diabetes Who Had Inadequate Glycemic Control with Metformin and DPP-4 inhibitor Combination Therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •1) Patients with type 2 diabetes between 20 to 75 years of age
- •2) 20= BMI =40 at the Screening Visit
- •3) Those who have been taking Metformin 1000 mg/day (immediate-release and hyper-release) + DPP-4 inhibitor* (metformin 1,000 mg/day + DPP4 inhibitor) at the same dose for at least 12 weeks prior to the Screening Visit.
- •* The types and doses of DPP-4 inhibitors allowed for combination therapy in this study are as follows.
- •Sitagliptin 100 mg/day
- •Vildagliptin 100mg/day
- •Saxagliptin 5 mg/day
- •Linagliptin 5 mg/day
- •Gemigliptin 50 mg/day
- •Teneligliptin 20 mg/day
- •Alogliptin 25 mg/day
- •Evogliptin 5 mg/day
- •Anagliptin 200 mg/day
- •4) 7%= HbA1c =10% at the Screening Visit
- •5) Those who spontaneously decides to participate in a Clinical Trial after hearing, fully understanding the detailed explanation of the Clinical Trial and consents in Writing
排除标准
- •1) Patients with type 1 diabetes, gestational diabetes, or secondary diabetes
- •2) Patients who have used SU, TZD, SGLT2i, insulin, and GLP-1 acceptor agonists within 8 weeks of screening visit
- •3) Patients with a history of hypersensitivity reactions to metformin, glimepiride, TZD, SGLT2i, DPP-4inhibitors, which are Investigational Products.
- •4) Patients with moderate or severe renal impairment (eGFR <60), end stage renal disease, or under dialysis
- •5) In case of ALT or AST at screening visit exceeds 2.5 times the normal upper limit
- •6) Patients with acute or chronic metabolic acidity including diabetic ketoacidosis and patients with a history of ketoacidosis
- •7) Patients with heart failure above NYHA class III
- •8) Patients with arrhythmia who have a history of myocardial infarction, unstable angina, and coronary artery bypass within 24 weeks of screening visit or need treatment
- •9) Patients with a history of severe hypoglycemia
- •10) Patients who have been tested to administer radiiodic contrast substances into blood vessels within 48 hours or scheduled during clinical trials based on the time of the screening visit
- •11) Patients with a history of malignant tumors within 5 years prior to the screening visit (except those diagnosed with underlying cell cancer, squamous cell cancer, or intraepithelial cancer in the cervix, or those who have never been treated or have no possibility of recurrence for at least 5 years prior to visit 1)
- •12) Patients who are receiving treatment for thyroid dysfunction at the Screening Visit (However, among patients undergoing thyroid hormone replacement therapy, those who have maintained a stable dose for more than 6 weeks before the screening visit can participate)
- •13) Patients who have chronically administered systemic corticosteroid within 8 weeks (over 14 days) as of the time of the screening visit.
- •14) Pregnant or lactating women
- •15) Patients who are judged to be inappropriate to participate in a clinical trial based on the Investigator judgement
研究者
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