A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus

Eli Lilly Japan K.K.0 个研究点开始时间: 2011年10月11日最近更新: 2023年10月17日

适应症

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研究类型: Interventional
分配方式: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

•Have Type 1 Diabetes Mellitus based on the disease diagnostic criteria (World Health Organization [WHO] Classification)
•-Have duration of diabetes greater than or equal to one year
•-Have HbA1c less than or equal to 11.0%
•-On basal-bolus insulin therapy for at least 1 year (basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine)
•-Have a body mass index (BMI) of less than or equal to 35 kg/m^2

•-Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
•-Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
•-Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
•-Have significant renal, cardiac, gastrointestinal or liver disease
•-Have active cancer or cancer within the past 5 years

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