A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin Lispro; Drug: SAR342434

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273258

2012-004453-86

U1111-1134-4816 (Other Identifier)

PDY12704

Details and patient eligibility

About

Primary Objective:

To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.

Secondary Objective:

To assess the safety and tolerability of SAR342434.

Full description

The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)

• Screening: 2 to 28 days (D -28 to D -2)
• Treatment period 1 - 3: 2 days (1 overnight stay)
• Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
• End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects with diabetes mellitus type 1 for more than one year.
• Total insulin dose of < 1.2 U/kg/day.
• Fasting negative serum C-peptide (< 0.3 nmol/L).
• Glycohemoglobin (HbA1c) ≤ 9%.
• Stable insulin regimen for at least 2 months prior to study.
• Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

Exclusion criteria

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
• More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (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.
• Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.
• Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).

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: Double Blind

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30 participants in 3 patient groups

Test (T)

Experimental group

Description:

SAR342434: single dose injection

Treatment:

Drug: SAR342434

Reference 1 (R1)

Active Comparator group

Description:

US-approved Humalog®: single dose injection

Treatment:

Drug: Insulin Lispro

Drug: Insulin Lispro

Reference 2 (R2)

Active Comparator group

Description:

EU-approved Humalog®: single dose injection

Treatment:

Drug: Insulin Lispro

Drug: Insulin Lispro