Comparison of Exposure and Activity of SAR342434 to Humalog in Healthy Japanese Male Subjects

A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog Using the Euglycemic Clamp Technique, in Healthy Japanese Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225283

Enrollment

Registered

2020-07-20

Start date

2017-10-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

investigational material(s) Generic name etc : SAR342434 INN of investigational material : insulin lispro Therapeutic category code : 249 Other hormone preparations (including antihormone preparations

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Japanese male subjects, between 20 and 45 years of age, inclusive. - Body weight between 50.0 and 90.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m^2, inclusive. - Certified as healthy by a comprehensive clinical assessment. - Normal vital signs. - Normal 12-lead electrocardiogram parameters - Laboratory parameters within the normal ranges.

Exclusion criteria

Exclusion criteria: - Any history or presence of clinically relevant medical disorders. - Frequent headaches and/or migraine, recurrent nausea and/or vomiting. - Symptomatic postural hypotension or asymptomatic postural hypotension. - Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. - History or presence of drug or alcohol abuse. - Any subject who has participated in any other clinical study prior to study. - Known hypersensitivity to insulin lispro or any of the excipients.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics 1. Assessment of PK parameter: Area under curve of plasma concentration Area under curve to the last measurable concentration of SAR342434/insulin lispro (INS-AUClast) [Time Frame: Day 1 of each treatment period] pharmacokinetics 2. Assessment of PK parameter: Maximum plasma concentration Maximum plama concentration of SAR342434/insulin aspart (INS-Cmax) [Time Frame: Day 1 of each treatment period] pharmacodynamics 3. Assessment of PD parameter: Area under curve of glucose infusion rate (GIR) Area under the body weight standardized GIR versus time curve from time zero to 10 hours after dosing (GIR-AUC0-10) [Time Frame: Day 1 of each treatment period] pharmacodynamics 4. Assessment of PD parameter: Maximum GIR Maximum smoothed body weight standardized GIR (GIRmax) [Time Frame: Day 1 of each treatment period]	—

Measure

Time frame

pharmacokinetics 1. Assessment of PK parameter: Area under curve of plasma concentration Area under curve to the last measurable concentration of SAR342434/insulin lispro (INS-AUClast) [Time Frame: Day 1 of each treatment period] pharmacokinetics 2. Assessment of PK parameter: Maximum plasma concentration Maximum plama concentration of SAR342434/insulin aspart (INS-Cmax) [Time Frame: Day 1 of each treatment period] pharmacodynamics 3. Assessment of PD parameter: Area under curve of glucose infusion rate (GIR) Area under the body weight standardized GIR versus time curve from time zero to 10 hours after dosing (GIR-AUC0-10) [Time Frame: Day 1 of each treatment period] pharmacodynamics 4. Assessment of PD parameter: Maximum GIR Maximum smoothed body weight standardized GIR (GIRmax) [Time Frame: Day 1 of each treatment period]

—

Secondary

Measure	Time frame
pharmacokinetics 1. Assessment of PK parameter: Area under curve of pasma concentration Area under curve extrapolated to infinity for SAR342434/insulin aspart (INS-AUC) [Time Frame: Day 1 of each treatment period] pharmacokinetics 2. Assessment of PK parameter: Half-life Elimination half-life of SAR342434/insulin aspart (INS-t1/2z) [Time Frame: Day 1 of each treatment period] pharmacokinetics 3. Assessment of PK parameter: Time to reach Cmax Time to reach Cmax of SAR342434/insulin aspart (INS-tmax) [Time Frame: Day 1 of each treatment period] pharmacodynamics 4. Assessment of PD parameter: Time to reach GIRmax Time to reach GIRmax (GIR-tmax) [Time Frame: Day 1 of each treatment period] safety 5. Adverse events (AEs) Number of subjects with AEs [Time Frame: Up to 8 weeks]	—

Measure

Time frame

pharmacokinetics 1. Assessment of PK parameter: Area under curve of pasma concentration Area under curve extrapolated to infinity for SAR342434/insulin aspart (INS-AUC) [Time Frame: Day 1 of each treatment period] pharmacokinetics 2. Assessment of PK parameter: Half-life Elimination half-life of SAR342434/insulin aspart (INS-t1/2z) [Time Frame: Day 1 of each treatment period] pharmacokinetics 3. Assessment of PK parameter: Time to reach Cmax Time to reach Cmax of SAR342434/insulin aspart (INS-tmax) [Time Frame: Day 1 of each treatment period] pharmacodynamics 4. Assessment of PD parameter: Time to reach GIRmax Time to reach GIRmax (GIR-tmax) [Time Frame: Day 1 of each treatment period] safety 5. Adverse events (AEs) Number of subjects with AEs [Time Frame: Up to 8 weeks]

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026