KCT0004509已完成未知
A Multicenter, Open-label, Two-arm Parallel-group, Non-inferiority Investigator-Initiated Trial to compare efficacy and safety of LObeglitazone or linagliptin add-on triple therapy in Type 2 Diabetes Mellitus patients under stable treatment with MEtformin and emPAgliflozin
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 136 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 136
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
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. Adult men or women aged between 19 and 79
- •2. Patients diagnosed with Type 2 diabetes mellitus (Refer to Diagnosis Criteria from 2018 ADA)
- •3. Patients under stable treatment with Metformin (2000 mg) and empagliflozin (10 mg) for more than 12 weeks, prior to the participation in the study
- •4. Patients with HbA1c of 7.0% or higher and less than 10. 5 %
- •5. Patients with BMI of 23 kg/m2 or higher and less than 45 kg/m2
- •6. Patients who agree to participate in the study and provide voluntary written consent
排除标准
- •1. Patients with known hypersensitivity to Investigational product, or concomitant medication and component, or drugs of the same type (biguanide, thiazolidinediones SGLT2 inhibitor, DPP4 inhibitor)
- •2. Patients with genetic problems, such as galactose intolerant Lapp lactose deficiency or glucose galactose absorption disorder
- •3. Patients with Type 1 Diabetes Mellitus or who need insulin supply through an insulin pump
- •4. Patients with Glomerular filtration rate (eGFR) < 60 mL / min / 1.73m2 (MDRD-GFR), patients with end stage renal disease (ESRD) or patients on dialysis
- •5. Patients with acute conditions that may affect renal function such as dehydration, severe infections, shock with cardiovascular collapse), patients with acute myocardial infarction, and patients with sepsis
- •6. Patients with severe heart failure or patients with medical history of NYHA (Heart Failure New York Heart Association) Class 3, 4 condition
- •7. Patients with acute and unstable hear failure
- •8. Patients received the test/examination involving intravenous administration of radioactive iodine contrast agents (e.g. intravenous urography, angiography, contrast medium, Computed tomography, etc.) within 48 hours prior to participation in the study, or expecting to receive during the study period
- •9. Patients with acute or chronic metabolic acidosis including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis
- •10. Patients with Diabetic pre-coma
- •11. Patients in pre and/or Post surgery status, patients with severe infection, patients with severe trauma, and patients with severe traumatic systemic disorder
- •12. Patients with malnutrition, starvation, weakness, pituitary or adrenal insufficiency
- •13. Patients with hepatic impairment (liver enzyme levels ALT and AST are more than three times the normal upper limit)
- •14. Patients with acute or chronic diseases that may cause tissue hypoxia (e.g., respiratory failure, acute myocardial infarction, shock)
- •15. Patients with gastrointestinal disorders such as diarrhea and vomiting
- •16. Patients with a medical history or treatment of bladder cancer within 5 years prior to screening
- •17. Patients receiving lobeglitazone or linagliptin within 3 months prior to study drug administration
- •18. Patients taking or expecting to take drugs for glycemic control except for Investigational Product or drugs that can have a significant effect on glycemic control (e.g. systemic corticosteroids) during the study period.
- •19. Patients taking or expecting to take obesity therapeutics and weight-controlling agent (Orlistat) during the study period, or patients undergoing aggressive weight control diet.
- •20. Patients with uncontrolled hypertension (SBP/DBP, 140 90 mmHg or higher)
- •21. Patients with hyperglycemic hyperosmolar nonketotic syndrome (HHNS)
- •22. Pregnant or breast-feeding women
- •23. Women or men of childbearing potential who are planning to become pregnant or do not intend to use appropriate contraceptives during the study period
- •24. Patients with alcohol abuse or drug dependence
- •25. Patients who participated in other clinical trials and received the study drug within 3 months prior to the screening visit
- •26. Other patients deemed inappropriate for participation in clinical trials by investigators
研究者
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