A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

• Status: Completed
• Trial end date: 2017-06-19
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks for each participant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump

• Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per meter squared (kg/m²), inclusive

• Have medical and laboratory test results that are acceptable for the study

• Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a second party) in the past 6 months

• Have venous access sufficient to allow for blood sampling

• Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

• Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study

• Had blood loss of more than 500 milliliters (mL) within the last month

• Have known allergies to LY900014, insulin lispro, related compounds or any components in the study drug formulations

• Have previously participated or withdrawn from this study

• Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study