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 人开始时间: 2021年2月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 471
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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
- •-Have vision loss or hearing loss that does not allow recognition of pump screens, alerts and alarms
研究者
相似试验
进行中（未招募）
1 期
A study in people with type 1 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insulin.Type 1 DiabetesMedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861EUCTR2015-005356-99-DEEli Lilly and Company1,567
进行中（未招募）
1 期
A study to compare an investigational ultra-rapid insulin, LY900014 with insulin lispro in children with type 1 diabetesDiabetes Mellitus, Type 1EUCTR2018-002371-18-PLEli Lilly and Company751
进行中（未招募）
不适用
A Prospective, Randomized, Double-Blind Comparisonof a Long-Acting Basal Insulin Analog LY2963016 toLantus® in Adult Patients with Type 2 Diabetes Mellitus - The ELEMENT 2 Studytype 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-000828-15-HUEli Lilly and Company792
进行中（未招募）
1 期
A study in people with type 1 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insulin.Type 1 DiabetesEUCTR2015-005356-99-GREli Lilly and Company1,199
进行中（未招募）
不适用
A Prospective, Randomized, Double-Blind Comparisonof a Long-Acting Basal Insulin Analog LY2963016 toLantus® in Adult Patients with Type 2 Diabetes Mellitus - The ELEMENT 2 StudyEUCTR2011-000828-15-PLEli Lilly and Company792