NCT02175784已完成4 期
Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 262
- 主要终点
- Change in HbA1C from baseline
研究概览
简要总结
The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.
详细描述
This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent.
- •Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days)
- •Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2
- •Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2
排除标准
- •Subject has type 1 diabetes mellitus
- •Subject has proliferative diabetic retinopathy
- •Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
- •Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent)
- •Subject has a symptomatic urinary tract infection or symptomatic genital infection
- •Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation)
- •Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1
- •Subject has unstable psychiatric disorder
- •Female subject who is currently pregnant or lactating, or who is possibly pregnant
- •Male and pre-menopausal female subject who cannot use an appropriate contraception during the study
- •Subject has severe infection, perioperative, or serious trauma
- •Subject has drug addiction or alcohol abuse
- •Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence)
- •Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action)
- •Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
- •Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study
研究组 & 干预措施
ipragliflozin group
Experimental
oral
干预措施: ipragliflozin (Drug)
placebo group
Experimental
oral
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1C from baseline
时间窗: Baseline and Week 16
次要结局
- Fasting plasma glucose(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Fructosamine concentration(Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52)
- Leptin concentration(Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52)
- Body weight(Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Adiponectin concentration(Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52)
- Waist circumference(Baseline, Week 16, 24, 52)
- Blood glucose values of self monitoring(Baseline, Week 8, 16, 24, 52)
- Safety assessed by the adverse events, vital signs. and laboratory tests(Up to 52 Weeks)
研究者
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