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

NCT03903016 | Completed Phase 1

• 3 other identifiers: BEQ158462018-003131-30U1111-1207-8959
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Assessment of pharmacokinetc (PK) parameter:INS-Cmax

  Maximum Insulin (INS) concentration

  10 hours

• Assessment of PK parameter :INS-AUClast -

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

  10 hours

Secondary Outcomes (8)

• 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

• Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8

  8 hours

• Assessment of PD parameter:GIR-max

  8 hours

Study Arms (2)

Test (T)

EXPERIMENTAL

Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period

Drug: Insulin Lispro SAR342434

Reference (R)

ACTIVE COMPARATOR

Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period

Drug: Insulin Lispro SAR342434

Interventions

Insulin Lispro SAR342434 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Test (T)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 2760001

Neuss, 41460, Germany

Location

Related Links

• BEQ15846 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: March 26, 2019
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)