Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT03916601

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2018-03-22

Brief Summary

Primary Objectives:

• To demonstrate similarity in exposure of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30 (cohort 1).
• To demonstrate distinctiveness in early and intermediate exposure of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution (cohort 2).

Secondary Objectives:

• To demonstrate similarity in activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30.
• To demonstrate distinctiveness in early and intermediate activity of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution.
• To assess the safety and tolerability of SAR341402 rapid-acting solution and SAR341402 Mix 70/30.

Detailed Description

• Cohort 1: The total study duration for a screened patient will be about 3 - 8 weeks (excluding screening), with screening period of 4 to 28 days, 3 treatment periods of 2 days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days after last IMP administration.
• Cohort 2: The total study duration for a screened patient will be about 2 - 5 weeks (excluding screening), with screening period of 4 to 28 days, 2 treatment periods of 2 days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days after last IMP administration.

Conditions

Type 1 Diabetes

Study Design

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

Study Groups

Test (T)

SAR341402 Mix 70/30: single dose injection

Group Type: EXPERIMENTAL

SAR341402

Intervention Type: DRUG

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Reference 1 (R1)

NovoLog Mix 70/30: single dose injection

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Reference 2 (R2)

NovoMix30: single dose injection

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Reference 3 (R3)

SAR341402 rapid-acting solution: single dose injection

Group Type: EXPERIMENTAL

SAR341402

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Interventions

SAR341402

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin Aspart

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin Aspart

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Intervention Type: DRUG

SAR341402

Pharmaceutical form: suspension for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

NovoLog Mix 70/30; Novo Mix 30

Eligibility Criteria

Inclusion Criteria

• Total insulin dose of < 1.0 U/kg/day.
• Total basal insulin dose ≤0.4 U/kg/day.
• Fasting serum C-peptide < 0.3 nmol/L.
• Anti-insulin antibody titer ≤30.0 kU/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 and/or hospitalized for diabetic ketoacidosis.
• 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 ≥30 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.
• 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: 64 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 Number 2760001

Neuss, , Germany

Countries

Germany

References

Kapitza C, Nosek L, Schmider W, Teichert L, Mukherjee B, Nowotny I. A single-dose euglycaemic clamp study in two cohorts to compare the exposure of SAR341402 (insulin aspart) Mix 70/30 with US- and European-approved versions of insulin aspart Mix 70/30 and SAR341402 rapid-acting solution in subjects with type 1 diabetes. Diabetes Obes Metab. 2021 Mar;23(3):674-681. doi: 10.1111/dom.14260. Epub 2020 Dec 10.

Reference Type: RESULT

PMID: 33236518 (View on PubMed)

Other Identifiers

2017-002482-22

Identifier Type: -

Identifier Source: secondary_id

U1111-1197-7984

Identifier Type: OTHER

Identifier Source: secondary_id

PDY15084

Identifier Type: -

Identifier Source: org_study_id