A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

NCT ID: NCT03202875

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-14
• Study Completion Date: 2012-12-28

Brief Summary

Primary Objective:

To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.

Secondary Objective:

To assess the safety and tolerability of SAR341402.

Detailed Description

The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the investigational product.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test (T)

SAR341402: single dose injection

Group Type: EXPERIMENTAL

SAR341402

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Reference 1 (R1)

NovoRapid®: single dose injection

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Reference 2 (R2)

NovoLog®: single dose injection

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Interventions

SAR341402

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin Aspart

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin Aspart

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

NovoRapid®; NovoLog®

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site 276001

Neuss, , Germany

Countries

Germany

References

Kapitza C, Nosek L, Schmider W, Teichert L, Nowotny I. Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes. Diabetes Technol Ther. 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351. Epub 2019 Dec 30.

Reference Type: DERIVED

PMID: 31825248 (View on PubMed)

Other Identifiers

2012-002355-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1127-2950

Identifier Type: OTHER

Identifier Source: secondary_id

PDY12695

Identifier Type: -

Identifier Source: org_study_id