JPRN-jRCTs031180205已完成4 期
A randomized controlled trial of a combination therapy with Ipragliflozin and sitagliptin combined with metformin in type 2 diabetes
Sone Hirohito0 个研究点目标入组 115 人开始时间: 2019年3月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
研究概览
简要总结
We compared the effects of ipragliflozin and sitagliptin after Japanese patients with type 2 diabetes had been taking Met and were without prior ASCVD in a 52-week randomized open-label trial. Although glycemic control did not differ between ipragliflozin and sitagliptin, some ASCVD risk factors such as BMI, C-peptide and HDL-C improved with ipragliflozin.
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
- •[Inclusion criteria before initiation of metformin monotherapy]
- •1) Type 2 diabetes
- •2) Aged from 20 to 80 years at providing consent
- •3) With poorly glycemic controlled, nevertheless undergo diet and exercise therapy or administrated oral hypoglycemic agents
- •4) HbA1c >= 6.5% and <10.0%
- •5) Provided written informed consent
- •[Inclusion criteria at randomization]
- •6) Patients who are only administrated identical dose of metformin (>= 500 mg/day) for 8 weeks or more
- •7) HbA1c >= 6.5% and <10.0%
排除标准
- •1) Type 1 diabetes
- •2) With severe ketosis, diabetic coma, or precoma within 6 months from the day of providing consent
- •3) With severe infection, pre or post surgery, and serious trauma
- •4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL)
- •5) With severe hepatic disorder
- •6) Has history of stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization
- •7) Has history of lactic acidosis
- •8) Patients who drink excessive alcohol
- •9) Has urinary tract infection, genital infection and dehydration at providing consent
- •10) Administrated insulin, GLP-1 receptor agonist within 1 year
- •11) Is pregnant, nursing, possibly pregnant and planned to become pregnant
- •12) Has history of hypersensitivity to SGLT-2 inhibitors, DDP-4 inhibitors and BG
- •13) Considered as inadequate by the investigator
研究者
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