NCT02291874已完成4 期
Postmarketing Clinical Study of Ipragliflozin - Long-term Study in Combination With GLP-1 Receptor Agonists in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- HbA1c
研究概览
简要总结
Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.
详细描述
This is a multicenter, open-label study in patients with T2DM who have inadequate glycemic control with GLP-1 receptor agonists for at least 6 weeks prior to Visit 1 (Week -6).
Patients on monotherapy with Victoza® or on combination therapy with GLP-1 receptor agonists and sulfonylurea (SU) are eligible. Patients on combination therapy with GLP-1 receptor agonists and non-SU hypoglycemic agents can also be included; however, these patients must undergo washout of the non-SU hypoglycemic agents administered with GLP-1 receptor agonists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The subject has a diagnosis of T2DM that was determined at least 12 weeks (84 days) before providing informed consent.
- •The subject has been receiving the same GLP-1 receptor agonist at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit
- •If on therapy with a concomitant SU, the subject has been receiving the same SU at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit
- •The subject has HbA1c levels of ≥7.5% but ≤10.5% at Visit 2, and the difference in HbA1c levels between Visit 1 and Visit 2 is within ±1.0%.
- •The subject has a BMI of ≥20.0 kg/m2 but ≤45.0 kg/m2 at Visit
- •If on therapy with a concomitant SU, the subject has fasting plasma glucose levels of ≥126 mg/dL at Visit 2.
排除标准
- •The subject has T1DM.
- •The subject has symptoms of dysuria, anuria, oliguria, or urinary retention.
- •The subject has proliferative retinopathy.
- •The subject has a history of clinically significant renal diseases such as renovascular occlusive disease, nephrectomy, or renal transplant.
- •The subject has a history of pancreatitis.
- •The subject has a history of recurrent urinary tract infections (≥3 episodes within 24 weeks before providing informed consent).
- •The subject has a symptomatic urinary tract infection or symptomatic genital infection.
- •The subject has a chronic disease that requires the continuous use of adrenocortical steroids and immunosuppressants (oral, injectable, or inhalational medications).
- •The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or serious heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1, or the subject has heart disease or cerebral vascular disease that, as per the judgment of the investigator or sub-investigator, may interfere with the treatment with ipragliflozin or safety evaluation of this study.
- •The subject has an unstable psychiatric disorder.
- •The subject is a female who is currently pregnant or lactating or could be pregnant.
- •The subject is unable or unwilling to practice an appropriate contraception method during the study.
- •The subject has severe infection, perioperative or serious trauma.
- •The subject has drug addiction or abuses alcohol.
- •The subject has a history of malignant tumors (except when he/she has been free from treatment for at least 5 years before providing informed consent and is not considered to have any recurrence).
- •The subject has a history of allergy to ipragliflozin or similar drugs that have an SGLT2 inhibitory action.
- •The subject has participated in a clinical study of an investigational product or medical device or post-marketing study within 12 weeks (84 days) before providing informed consent or is currently participating in any of these studies.
- •The subject is unable or unwilling, or does not agree, to comply with the study requirements, including the hospital visits, dose instructions, and the subject's responsibilities.
研究组 & 干预措施
Ipragliflozin group
Experimental
Ipragliflozin treatment
干预措施: Ipragliflozin (Drug)
结局指标
主要结局
HbA1c
时间窗: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
Fasting plasma glucose
时间窗: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
次要结局
- Fasting serum insulin(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Serum glucagon(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Serum glycoalbumin(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Serum leptin(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Serum adiponectin(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Body weight(0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Waist circumference(at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week)
- Self-measured blood glucose(at 0, 20, 52-week)
- Adverse events (AEs), vital signs, and laboratory tests(All treatment period)
研究者
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