A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lyumjev Lyumjev administered subcutaneously (SC) during a meal and following different approaches for basal reduction prior to exercise |
Drug: Lyumjev
Administered SC.
Other Names:
|
Active Comparator: Humalog Humalog administered SC during a meal and following different approaches for basal reduction prior to exercise |
Drug: Humalog
Administered SC.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Plasma Glucose (PG) From the Start to the End of Exercise for Each Treatment Arm [Predose up to 240 minutes postdose]
Change From Baseline in PG From the Start to the End of Exercise for Each Treatment Arm
Secondary Outcome Measures
- Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) for Each Treatment Arm [Predose up to 240 minutes postdose]
Change From Baseline in PPG Excursion During MMTT for Each Treatment Arm
Eligibility Criteria
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:
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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
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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
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Participants who have an abnormal blood pressure and/or pulse rate
-
Participants with clinically significant cardiac or pulmonary disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | LMC Clinical Research Inc. (Bayview) | Toronto | Ontario | Canada | M4G 3E8 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17278
- I8B-MC-ITSU