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CompletedNCT03916601Updated Apr 25, 2022

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

A Phase 1 interventional study of SAR341402 and Insulin Aspart in Type 1 Diabetes, sponsored by Sanofi. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2018, 8 years 6 months ago, and no results have been posted to the registry.
  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2017, registered Apr 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 52 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Test (T)

    SAR341402 Mix 70/30: single dose injection

    Drug: SAR341402

  • Active comparator
    Reference 1 (R1)

    NovoLog Mix 70/30: single dose injection

    Drug: Insulin Aspart

  • Active comparator
    Reference 2 (R2)

    NovoMix30: single dose injection

    Drug: Insulin Aspart

  • Experimental
    Reference 3 (R3)

    SAR341402 rapid-acting solution: single dose injection

    Drug: SAR341402

Interventions

  • DrugSAR341402

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • DrugInsulin Aspart

    Pharmaceutical form: suspension for injection Route of administration: subcutaneous

    Also known as: NovoLog Mix 70/30

  • DrugInsulin Aspart

    Pharmaceutical form: suspension for injection Route of administration: subcutaneous

    Also known as: Novo Mix 30

  • DrugSAR341402

    Pharmaceutical form: suspension for injection Route of administration: subcutaneous

06

What researchers measure

Primary outcomes

  1. (Cohort 1) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax)

    Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30, NovoLog Mix 70/30, NovoMix 30 and SAR341402 within 24 hours

    Time frame: 24 hours

  2. (Cohort 1) Assessment of PK parameter: Area under the insulin concentration time curve (INS-AUClast)

    INS-AUC of SAR341402 Mix 70/30, NovoLog Mix 70/30, and NovoMix 30 from 0 to 24 hours

    Time frame: 0 to 24 hours

  3. (Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H)

    INS-AUC0-4H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 0 to 4 hours

    Time frame: 0 to 4 hours

  4. (Cohort 2) Area under the insulin concentration time curve from 4 to 12 hours post administration (INS-AUC4-12H)

    INS-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 4 to 12 hours

    Time frame: 4 to 12 hours

  5. (Cohort 2) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax)

    (Cohort 2) Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Assessment of PK parameter: Area under the insulin concentration time curve from 0 to infinity (INS-AUC)

    (Cohort 1) INS-AUC for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30 from 0 to 24 hours

    Time frame: 0 to 24 hours

  2. Assessment of PK parameter: Area under the insulin concentration time curve for fractional periods post administration (INS-AUC0-4H, INS-AUC0-24H, INS-AUC4-24H)

    (Cohort 1) INS-AUC0-4H, INS-AUC0-24H, INS-AUC4-24H for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30

    Time frame: 0 to 4 hours, 0 to 24 hours, and 4 to 24 hours

  3. Assessment of PK parameter: Time to INS-Cmax

    (Cohort 1) INS-tmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours - 4. 24 hours - 5. 0 to 24 hours - 6. 24 hours - 7. 24 hours - 8. 24 hours - 9. 0 to 4 hours - 10. 4 to 12 hours - 11. 24 hours - 12. 24 hours -

  4. Assessment of PK parameter: Half-life (t1/2)

    (Cohort 1) INS-t1/2z for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30 within 24 hours

    Time frame: 24 hours

  5. Assessment of PD parameter: GIR versus time curve from 0 to 24 hours post administration (GIR-AUC0-24H)

    (Cohort 1) The area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 24 hours post administration for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30 from 0 to 24 hours

    Time frame: 0 to 24 hours

  6. Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax)

    (Cohort 1) GIRmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

  7. Assessment of PD parameter: Time to GIRmax (GIR-tmax)

    (Cohort 1) GIR-tmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

  8. Assessment of PK parameter: Time to Cmax (INS-tmax)

    (Cohort 2) INS-tmax for SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

  9. Assessment of PD parameter: The area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 4 hours post administration (GIR-AUC0-4H)

    (Cohort 2) GIR-AUC0-4H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 0 to 4 hours

    Time frame: 0 to 4 hours

  10. Assessment of PD parameter: The area under the body weight standardized glucose infusion rate (GIR) versus time curve from 4 to 12 hours post administration (GIR-AUC4-12H)

    (Cohort 2) GIR-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 4 to 12 hours

    Time frame: 4 to 12 hours

  11. Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax)

    (Cohort 2) GIRmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

  12. Assessment of PD parameter: Time to GIRmax (GIR-tmax)

    (Cohort 2) GIR-tmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours

    Time frame: 24 hours

07

Study locations

1 site
  • Investigational Site Number 2760001
    Neuss, 41460, Germany
08

References and documents

Publications

  • 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. PubMed 33236518 ↗

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03916601
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Apr 16, 2019
Start date
Dec 13, 2017
Primary completion
Mar 22, 2018
Completion
Mar 22, 2018
Last update
Apr 25, 2022

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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