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

NCT03202875 | Completed Phase 1

• 3 other identifiers: PDY126952012-002355-42U1111-1127-2950
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (4)

• Assessment of PK parameters: maximum plasma concentration (Cmax)

  Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours

  12 hours

• Assessment of PK parameters: Area under the concentration versus time curve (AUC)

  INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours

  12 hours

• Assessment of PK parameter: AUC from dosing to last concentration (AUClast)

  INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours

  12 hours

• Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR)

  Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)

  12 hours

Secondary Outcomes (9)

• Assessment of PK: Fractional area under the concentration versus time curve

  12 hours

• Assessment of PK: Time to 20 % of INS-AUC

  12 hours

• Assessment of PK: time to reach INS-Cmax (INS-tmax)

  12 hours

• Assessment of PK: time to reach INS-t1/2z (INS-t1/2z)

  12 hours

• Assessment of PD: Fractional area under the body weight standardized GIR versus time curve

  12 hours

Study Arms (3)

Test (T)

EXPERIMENTAL

SAR341402: single dose injection

Drug: SAR341402

Reference 1 (R1)

ACTIVE COMPARATOR

NovoRapid®: single dose injection

Drug: Insulin Aspart

Reference 2 (R2)

ACTIVE COMPARATOR

NovoLog®: single dose injection

Drug: Insulin Aspart

Interventions

SAR341402 DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Test (T)

Insulin Aspart DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: NovoRapid®

Reference 1 (R1)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site 276001

Neuss, Germany

Location

Related Publications (1)

• 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.

  PMID: 31825248 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: November 14, 2012
• Primary Completion: December 28, 2012
• Study Completion: December 28, 2012
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)