JPRN-jRCT1080223195未知4 期
An exploratory study of the effects of trelagliptin and alogliptin on glycemic variation in patients with type 2 diabetes mellitus
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 27 人开始时间: 2016年5月11日最近更新:
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 27
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 ot applicable（—）
- 性别
- All
入选标准
- •1.Research subjects who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
- •2.Patients who are able to sign and date the informed consent form and information sheet prior to the start of study procedures
- •3.Patients diagnosed with type 2 diabetes mellitus
- •4.Patients with an HbA1c (NGSP value) value >= 6.5% and < 8.5% at the start of the observation period (Day -2)
- •5.Patients who experience a =< +-1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks
- •6.Patients receiving stable dietetic therapy and exercise therapy (if performed) for >= 4 weeks before the start of the observation period
- •7.Patients, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) HMG-CoA reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
- •8.Men or women aged 20 years or older at the time of informed consent
排除标准
- •1.Patients who received anti-diabetic medications within 4 weeks prior to the start of the observation period
- •2.Patients who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors =< 4 weeks before the start of the observation period.
- •3.Patients with clinically evident hepatic dysfunction (e.g., AST or ALT >= 2.5-fold the upper limit of normal at the start of the observation period [Day -2])
- •4.Patients with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2])
- •5.Patients with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases
- •6.Patients with a history of gastric or small intestinal resection
- •7.Patients with proliferative diabetic retinopathy
- •8.Patients warranting insulin therapy for glycemic control (e.g, patients with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative patients, or serious trauma)
- •9.Patients with a history of hypersensitivity or allergy to DPP-4 inhibitors
- •10.Patients who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2)
- •11.Patients with any malignant tumors
- •12.Habitual drinkers whose average daily alcohol consumption is > 100 mL
- •13.Patients who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert
- •14.Patients anticipated to require any prohibited concomitant medications during the study period
- •15.Patients who are day and night lifestyle reversal
- •16.Patients participating in any other clinical studies at the time of informed consent for this study
- •17.Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant
- •18.Other patients who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator
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