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

NCT05262387 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17278I8B-MC-ITSU
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Lyumjev; Humalog®; Insulin lispro; Exercise; Continuous Subcutaneous Insulin Infusion; Glycemic control; Hypoglycemia; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.

  Start (0 minute) to end of exercise (60 minutes)

Secondary Outcomes (1)

• 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)

  Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT

Study Arms (4)

Treatment Sequence 1: ADBC

EXPERIMENTAL

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.

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

Treatment Sequence 2: BACD

EXPERIMENTAL

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.

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

Treatment Sequence 3: CBDA

EXPERIMENTAL

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.

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

Treatment Sequence 4: DCAB

EXPERIMENTAL

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.

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

Interventions

Lyumjev with 50% basal rate reduction DRUG

Administered SC.

Also known as: LY900014

Treatment Sequence 1: ADBC; Treatment Sequence 2: BACD; Treatment Sequence 3: CBDA; Treatment Sequence 4: DCAB

Humalog with 50% basal rate reduction DRUG

Administered SC.

Also known as: Insulin Lispro

Treatment Sequence 1: ADBC; Treatment Sequence 2: BACD; Treatment Sequence 3: CBDA; Treatment Sequence 4: DCAB

Humalog with 100% basal rate reduction DRUG

Administered SC.

Also known as: Insulin Lispro

Treatment Sequence 1: ADBC; Treatment Sequence 2: BACD; Treatment Sequence 3: CBDA; Treatment Sequence 4: DCAB

Lyumjev with 100% basal rate reduction DRUG

Administered SC.

Also known as: LY900014

Treatment Sequence 1: ADBC; Treatment Sequence 2: BACD; Treatment Sequence 3: CBDA; Treatment Sequence 4: DCAB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (%)
• Able to undergo at least 1 hour of moderate-intensity exercise

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 2, 2022
• Study Start: February 14, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)