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Insulin

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

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start (0 minute) to end of exercise (60 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests LY900014 (Lyumjev), a fast-acting insulin, in people with type 1 diabetes who use insulin pumps. It aims to see how well it controls blood sugar during exercise and after eating. Ultra rapid lispro (URLi) is a new insulin lispro formulation that has accelerated absorption and improved postprandial glucose control.

Eligible Conditions

Type 1 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start (0 minute) to end of exercise (60 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start (0 minute) to end of exercise (60 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and start (0 minute) to end of exercise (60 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise

Secondary study objectives

Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment Sequence 4: DCABExperimental Treatment4 Interventions

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.

Group II: Treatment Sequence 3: CBDAExperimental Treatment4 Interventions

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.

Group III: Treatment Sequence 2: BACDExperimental Treatment4 Interventions

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.

Group IV: Treatment Sequence 1: ADBCExperimental Treatment4 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Humalog with 100% basal rate reduction

2022

Completed Phase 1

~30

Lyumjev with 50% basal rate reduction

2022

Completed Phase 1

~30