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

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Glargine; Drug: Insulin Lispro; Drug: LY900014; Drug: Insulin Degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT03952130

I8B-FH-ITSD (Other Identifier)

16829

Details and patient eligibility

About

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).

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

354 participants in 2 patient groups

LY900014

Experimental group

Description:

Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec

Drug: LY900014

Insulin Lispro (Humalog)

Active Comparator group

Description:

Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec

Drug: Insulin Lispro