Adults 18 to 70, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)Primary· Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Group
Value
95% CI
LY900014
970
± 57
Insulin Lispro (Humalog)
968
± 56
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration CurveSecondary· Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm
Group
Value
95% CI
LY900014 Before Meal
207
± 189
LY900014 After Meal
264
± 205
Insulin Lispro (Humalog) Before Meal
227
± 163
Insulin Lispro (Humalog) After Meal
327
± 212
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT04605991 — A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Ti
· Phase 3
· completed
NCT04585776 — A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
· Phase 2
· completed
NCT04276207 — A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Ins
· Phase 1
· completed
NCT04049123 — A Study of LY900014 in Healthy Chinese Participants
· Phase 1
· completed
NCT03952130 — A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
· Phase 3
· completed
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Currently open trials in the same condition.
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NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar
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Other Eli Lilly and Company trials
Trials by the same sponsor.
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· Phase 2
· not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants
· Phase 1
· completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
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NCT07030127 — A Study of LY3985863 in Healthy Participants
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 14 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03341299.