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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin Lispro SAR342434

Study type: Interventional

Funder types: Industry

Identifiers

NCT03903016

BEQ15846

2018-003131-30 (EudraCT Number)

U1111-1207-8959 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Test (T)

Experimental group

Description:

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

Treatment:

Drug: Insulin Lispro SAR342434

Drug: Insulin Lispro SAR342434

Reference (R)

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Lispro SAR342434

Drug: Insulin Lispro SAR342434