A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Humalog with 50% basal rate reduction; Drug: Lyumjev with 50% basal rate reduction; Drug: Humalog with 100% basal rate reduction; Drug: Lyumjev with 100% basal rate reduction

Study type: Interventional

Funder types: Industry

Identifiers

NCT05262387

17278

I8B-MC-ITSU (Other Identifier)

Details and patient eligibility

About

This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants with type 1 diabetes
• Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive
• Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
• Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial
• Able to undergo at least 1 hour of moderate-intensity exercise

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
• Have a blood loss of more than 500 milliliters (mL) within the last month
• Have known allergies to insulin lispro, related compounds or any components of the study drug formulation
• Have previously participated or withdrawn from this study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
• Participants who have an abnormal blood pressure and/or pulse rate
• Participants with clinically significant cardiac or pulmonary disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

25 participants in 4 patient groups

Treatment Sequence 1: ADBC

Experimental group

Description:

Period 1: Lyumjev with 50% basal rate reduction (Treatment A) Period 2: Humalog with 100% basal rate reduction (Treatment D) Period 3: Lyumjev with 100% basal rate reduction (Treatment B) Period 4: Humalog with 50% basal rate reduction (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.

Treatment:

Drug: Lyumjev with 100% basal rate reduction

Drug: Humalog with 100% basal rate reduction

Drug: Humalog with 50% basal rate reduction

Drug: Lyumjev with 50% basal rate reduction

Treatment Sequence 2: BACD

Experimental group

Description:

Period 1: Lyumjev with 100% basal rate reduction (Treatment B) Period 2: Lyumjev with 50% basal rate reduction (Treatment A) Period 3: Humalog with 50% basal rate reduction (Treatment C) Period 4: Humalog with 100% basal rate reduction (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.

Treatment:

Drug: Lyumjev with 100% basal rate reduction

Drug: Humalog with 100% basal rate reduction

Drug: Humalog with 50% basal rate reduction

Drug: Lyumjev with 50% basal rate reduction

Treatment Sequence 3: CBDA

Experimental group

Description:

Period 1: Humalog with 50% basal rate reduction (Treatment C) Period 2: Lyumjev with 100% basal rate reduction (Treatment B) Period 3: Humalog with 100% basal rate reduction (Treatment D) Period 4: Lyumjev with 50% basal rate reduction (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.

Treatment:

Drug: Lyumjev with 100% basal rate reduction

Drug: Humalog with 100% basal rate reduction

Drug: Humalog with 50% basal rate reduction

Drug: Lyumjev with 50% basal rate reduction

Treatment Sequence 4: DCAB

Experimental group

Description:

Period 1: Humalog with 100% basal rate reduction (Treatment D) Period 2: Humalog with 50% basal rate reduction (Treatment C) Period 3: Lyumjev with 50% basal rate reduction (Treatment A) Period 4: Lyumjev with 100% basal rate reduction (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.

Treatment:

Drug: Lyumjev with 100% basal rate reduction

Drug: Humalog with 100% basal rate reduction

Drug: Humalog with 50% basal rate reduction

Drug: Lyumjev with 50% basal rate reduction