A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.

• 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

• Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive

• Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)

• Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial

Exclusion Criteria:

• Known or suspected hypersensitivity to investigational medical product(s) or related products

• Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial

• Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption

• Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination

• Widespread subcutaneous lipodystrophy in the abdomen

• Current use of any glucose-lowering agents other than insulin within 3 months prior to screening

• Chronic or recent use of corticosteroids