JPRN-jRCTs031200366进行中（未招募）未知
Safety of Anagliptin and MEtformin combination tablets evaluated by non-inferiority between pre- and post-serum Lactate levels In Japanese patients Of type 2 diabetes and moderate renal impairment - AMELIO STUDY
Kajio Hiroshi0 个研究点目标入组 38 人开始时间: 2021年2月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria are included in this study:
- •1. Outpatients with type 2 diabetes mellitus (without any plans of hospitalization).
- •2. Subjects who used DPP-4 inhibitors for 8 weeks before consenting without any change in the usage, dose, and type of the DPP-4 inhibitors.
- •3. Subjects whose latest HbA1c within 10 weeks before consenting is 7.0% or higher, and less than 10.0%.
- •4. Subjects whose latest eGFRcreat within 10 weeks before consenting is 30 mL/min/1.73m2 or higher, and less than 60 mL/min/1.73m2.
- •5. Subjects aged 20 years or older, and younger than 75 years.
- •6. Subjects who give their consent in a written form.
排除标准
- •Subjects who fall into any of the following criteria are excluded from participating in the study:
- •1. Subjects who used biguanide within 8 weeks before consenting.
- •2. Subjects who used GLP-1 receptor agonist within 8 weeks before consenting.
- •3. Subjects who have history of hypersensitivity against anagliptin or biguanide.
- •4. Subjects who have history of lactic acidosis.
- •5. Subjects with severe renal dysfunction (eGFR is less than 30 ml/min/1.73m2) or subjects who are treated with dialysis.
- •6. Subjects with severe hepatic dysfunction.
- •7. Subjects have stroke, cerebral infarction, severe cardiovascular or pulmonary dysfunction (such as shock lung, heart failure, myocardial infarction, and pulmonary embolism), or subjects who are prone to hypoxemia.
- •8. Subjects with dehydration or subjects who are prone to dehydration (subjects with gastrointestinal dysfunction such as diarrhea or vomiting, subjects who have difficulty in ingestion).
- •9. Subjects with excess alcohol drinking.
- •10. Subjects with severe ketosis, diabetic coma, precoma, or type 1 diabetes mellitus.
- •11. Subjects with severe infection, during a perioperative period, or severe physical injury.
- •12. Subjects with malnutrition, starvation, debilitation, pituitary dysfunction, or adrenal dysfunction.
- •13. Subjects who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
- •14. Subjects with malignant tumor, or subjects who have history of malignant tumor. However, those who have completed treatment and/or show no redevelopment of malignant tumor, as well as manifest some degree of remission can be considered to be participants of this study.
- •15. Subjects who need legal representative for giving their consent.
- •16. Subjects who are considered to be unsuitable for participating in this study by investigators.
研究者
相似试验
招募中
不适用
Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.Type 2 diabetesJPRN-UMIN000034599Minami Osaka hospital120
已完成
不适用
Effects of anagliptin/metformin combination tablets: a retrospective observational studyType 2 diabetes mellitusJPRN-UMIN000041979Fukuda Clinic90
进行中（未招募）
4 期
TIME-TG studyType2 DiabetesJPRN-jRCTs051200098Murata Koichiro20
暂停
1 期
A Randomised Double-Blind Controlled Trial of Metformin and Atorvastatin – with treatment commenced following prostatic biopsy and ceasing just before radical prostatectomy - to guide subsequent patient managementCancer - ProstateProstate cancerACTRN12615000571572niversity of Queensland Centre for Clinical Research80
招募中
不适用
Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first studyType2 diabetesJPRN-UMIN000035791Yokohama City University Medical Center99