Phase 1
Completed N=25
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT05262387 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise — -26.8; -46.9; -39.0; -60.5 milligram per Deciliter (mg/dL) — p=0.0494
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise |
-26.8; -46.9; -39.0; -60.5 | 0.0494 sig |
| SECONDARY 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) |
247; 257; 202; 262 | 0.1998 |
Eligibility Criteria
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- Have previously participated or withdrawn from this study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
Data sourced from ClinicalTrials.gov (NCT05262387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.