EUCTR2015-005358-36-IT
进行中（未招募）
1 期
A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion - PRONTO Pump 2
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 471 人2021年2月11日
相关药物Humalog
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- 入组人数
- 471
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Men or women diagnosed (clinically) with T1D for at least 1 year prior to screening, and continuously using insulin for at least 1 year
- •Are at least 18 years of age
- •Have been using CSII therapy for a minimum of 6 months prior to screening. Interruption of CSII is allowed during the 6 months prior to screening for up to a total of 14 days.
- •Must be using a MiniMed 530G or 630G (US), 640G (EU), insulin pump for at least the last 90 days and willing to stay on the same pump throughout the study
- •Are willing to maintain their current bolus delivery speed (standard or quick) for the duration of the study
- •Have HbA1c values of \=6\.5 and \=9\.0%, as determined by the central laboratory at screening (Visit 1\)
- •Have a body mass index (BMI) of \=35\.0 kg/m2 at screening (Visit 1\)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
排除标准
- •\-Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol
- •\-Have hypoglycemia unawareness as judged by the investigator
- •\-Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening
- •\-Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or DKA) within 6 months prior to screening
- •\-Have cardiovascular disease, within the last 6 months prior to screening, defined as stroke, decompensated heart failure New York Heart Association class III or IV (CCNYHA 1994\), myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary arterial bypass graft
- •History of renal transplantation or currently receiving renal dialysis
- •\-Hepatic: have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis)
- •\-Hematologic: have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia that is clinically significant based on investigator judgement
- •\-Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations; includes those with gastric bypass) in the opinion of investigator
- •\-Have a history of abscess at an infusion site within the last 90 days prior to screening
结局指标
主要结局
未指定
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