Phase 1 Completed N=54 Randomized Double-blind Basic Science

A Study of Lispro Formulations in Healthy Participants

Healthy Volunteers

Source: ClinicalTrials.gov NCT02293551 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcomePrimary: Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) — 916; 957; 1020; 972 picomole*hour/Liter (pmol*hr/L) — p=0.2071

Summary

The purposes of this study are to determine: * Part A * How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation. * The safety of insulin lispro in different formulations and any side effects that might be associated with it. * Part B: * How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A). * The safety of insulin lispro in different formulations and any side effects that might be associated with it. Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])	916; 957; 1020; 972; 971; 864	0.2071

Eligibility Criteria

Inclusion Criteria

Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion Criteria

Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02293551). 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.