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Insulin Lispro SAR342434

Phase 1

Type 1 Diabetes | Small molecule | Metabolic |Sanofi|Trials Updated: Sep 24, 2025

Insulin Lispro SAR342434 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2019

Insulin Lispro SAR342434 target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Insulin lispro Sanofi®

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Insulin Lispro SAR342434 clinical trials

Insulin Lispro SAR342434 · 1 trial · 1 indication

Phase 1 1
NCT03903016A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 DiabetesType 1 Diabetes
COMPLETED90 Analytics
PHASE1COMPLETED
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of pharmacokinetc (PK) parameter:INS-Cmax
10 hours

Maximum Insulin (INS) concentration

Assessment of PK parameter :INS-AUClast -
10 hours

Area under INS concentration time curve from 0 to last measurable concentration -

Secondary Endpoints

Assessment of PK parameter:INS-AUC
10 hours
Assessment of PK parameter:INS-tmax
10 hours
Assessment of PK parameter:INS-t1/2z
10 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Test (T)EXPERIMENTALInsulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period
Reference (R)ACTIVE_COMPARATORInsulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period

Interventions

NameTypeDescription
Insulin Lispro SAR342434DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria : * Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \<1.0 U/kg/day * Fasting serum C-peptide \<0.30 nmol/L at screening * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening * Sta...

Countries:Germany
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Frequently asked questions about Insulin Lispro SAR342434

What is Insulin Lispro SAR342434?

Insulin Lispro SAR342434 is an investigational insulin lispro formulation developed by Sanofi for the treatment of Type 1 Diabetes. It is a small molecule that acts as an agonist at the insulin receptor (INSR). The program has been studied in a Phase 1 bioequivalence trial comparing two different strength formulations.

What is Insulin Lispro SAR342434 used for in Type 1 Diabetes?

Insulin Lispro SAR342434 is being developed for use in Type 1 Diabetes, where it is intended to provide insulin replacement therapy. It is an insulin receptor agonist. The only clinical study to date evaluated its use in patients with Type 1 Diabetes, not in healthy volunteers.

What does Insulin Lispro SAR342434 target?

Insulin Lispro SAR342434 targets the insulin receptor, INSR, and acts as an agonist at that receptor. By activating INSR, it is designed to mimic the metabolic actions of endogenous insulin. This mechanism underlies its development for Type 1 Diabetes.

Who makes Insulin Lispro SAR342434?

Insulin Lispro SAR342434 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this insulin lispro formulation. The asset is identified in public chemical databases under the ChEMBL ID CHEMBL1201631.

What phase is Insulin Lispro SAR342434 in?

Insulin Lispro SAR342434 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program's single Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is Insulin Lispro SAR342434 in?

Insulin Lispro SAR342434 has been studied in one completed Phase 1 trial, NCT03903016, titled a bioequivalence study comparing two different strength formulations of insulin lispro in patients with Type 1 Diabetes. The trial enrolled 90 participants in Germany, was randomized, double blind, and active controlled.