Conditions: Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 138
Healthy volunteers: no

Brief summary:
Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine

Detailed description:
Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.

Arms:
arm 1: Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks. arm 2: Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.

Interventions: intervention 1: LY2605541 intervention 2: Insulin glargine
Intervention descriptions: intervention 1: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods. intervention 2: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.

Protocol document: