CompletedNCT03903016Updated Sep 24, 2025

A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

A Phase 1 interventional study of Insulin Lispro SAR342434 and Insulin Lispro SAR342434 in Type 1 Diabetes, sponsored by Sanofi. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

Primary Objective:

To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose

Secondary Objectives:

To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
To assess the safety and tolerability of the test and the reference formulation of insulin lispro

Read the detailed description

Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

Conditions studied

Type 1 Diabetes

Browse trials for

Diabetes Mellitus, Type 1 3,522

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 90 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

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
Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L
Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive

Exclusion criteria

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month).
Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
If female, pregnancy (defined as positive β-HCG blood test), breast-feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 90 participants (actual)

Study arms

Experimental
Test (T)
Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period
Drug: Insulin Lispro SAR342434
Active comparator
Reference (R)
Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period
Drug: Insulin Lispro SAR342434

Interventions

DrugInsulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous
DrugInsulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Also known as: Insulin lispro Sanofi®

What researchers measure

Primary outcomes

Assessment of pharmacokinetc (PK) parameter:INS-Cmax
Maximum Insulin (INS) concentration
Time frame: 10 hours
Assessment of PK parameter :INS-AUClast -
Area under INS concentration time curve from 0 to last measurable concentration -
Time frame: 10 hours

Secondary outcomes

Assessment of PK parameter:INS-AUC
Area under INS concentration time curve from 0 to infinity
Time frame: 10 hours
Assessment of PK parameter:INS-tmax
Time to reach INS-Cmax
Time frame: 10 hours
Assessment of PK parameter:INS-t1/2z
INS terminal half life
Time frame: 10 hours
Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8
Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours
Time frame: 8 hours
Assessment of PD parameter:GIR-max
Maximum smoothed GIR
Time frame: 8 hours
Assessment of PD parameter:GIR-tmax
Time to reach GIR-max
Time frame: 8 hours
Duration of blood glucose control
Duration of blood glucose control at or below 105 mg/dL
Time frame: 8 hours
Adverse Events
Number of participants with adverse events
Time frame: Up to Day 62

Study locations

1 site

Investigational Site Number 2760001
Neuss, 41460, Germany

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03903016
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Apr 4, 2019
Start date: Mar 26, 2019
Primary completion: Aug 19, 2019
Completion: Aug 19, 2019
Last update: Sep 24, 2025

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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