A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

• Status: Active, not recruiting
• Trial end date: 2021-12-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.

• Participants must have HbA1c of ≥7.0 and ≤10.0%.

• Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.

• Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).

Exclusion Criteria:

• Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days of screening.

• Participants must not have had more than 1 severe hypoglycemic episode within 6 months of screening.

• Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.