Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Type 1 Diabetes Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 536
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

Detailed description:

Arms:
arm 1: LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. arm 2: Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Interventions: intervention 1: LY2963016 intervention 2: Lantus intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously intervention 3: Administered subcutaneously

Protocol document: