JPRN-jRCTs061190008已完成未知
The Study of Effect of antidiabetic agents on pancreatic beta-Cell REsponsiveness To glucose; comparative Evaluation of DPP-4 Inhibitors and SGLT2 inhibitor, Luseogliflozin - SECRETE-I study
Kaneto Hideaki0 个研究点目标入组 113 人开始时间: 2019年6月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 113
研究概览
简要总结
Both luseogliflozin and teneligliptin significantly improved beta-cell function in patients with type 2 diabetes who had not achieved the target for HbA1c value, and there were no significant differences in their effects. The improvement in beta-cell function was more pronounced in patients with inadequate insulin secretion in response to insulin resistance.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •Patients meeting the following criteria will be included in the study.
- •1.patients with type 2 diabetes mellitus whose HbA1c is 7.0% or higher and less than 9.0%, despite diet and exercise therapy alone (drug-naive) or anti-diabetic agent treatment other than DPP-4 inhibitors or SGLT2 inhibitors for 12 weeks or longer in addition to diet and exercise therapy
- •2.patients who do not start to use anti-diabetic agent or who do not increase the dose of anti-diabetic agent within 12 weeks before giving their consent
- •3.male and female aged >= 20 years and < 80 years
- •4.patients whose body mass index (BMI) is 20 kg/m2 or higher
- •5.Patients who provide written consent form to participate in this study after full explanation of the study
排除标准
- •Patients meeting any of the following exclusion criteria will be excluded from the study
- •1.patients with type 1 diabetes mellitus
- •2.patients with diabetes mellitus which was caused by specific mode of action or diseases, such as exocrine pancreatic insufficiency, endocrine disorder, drug-induced, or hereditary diseases
- •3.patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
- •4.patients who used insulin or GLP-1 receptor agonist within 12 weeks before giving their consent
- •5.patients with history of myocardial infarction, cerebral stroke within 12 weeks before giving their consent
- •6.patients with severe infection, during a perioperative period, or with severe physical injury
- •7.patients with severe liver disease (patients with AST or ALT value five times or higher of the upper limit of the stand value in research institution)
- •8.patients with severe renal disease (eGFR of less than 30 mL/min/1.73m2)
- •9.patients with dehydration (patients who complain to have a symptom of dehydration)
- •10.patients with urinary tract infection or genital infection
- •11.patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
- •12.patients with hypersensitivity or contraindication to any medical component of each study drug
- •13.patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period)
- •14.patients who are considered to be unsuitable for participation by investigators
研究者
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