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Clinical Trials/NCT03916601
NCT03916601CompletedPhase 1

A Randomized, Double-blind, Single-dose, Cross-over Study in Two Cohorts to Compare Exposure and Activity of SAR341402 Mix 70/30 to Novolog® Mix 70/30, Novomix® 30 and SAR341402 Rapid-Acting Solution Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Sanofi1 site in 1 country52 target enrollmentStarted: December 13, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Sanofi
Enrollment
52
Locations
1
Primary Endpoint
(Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Test (T)

Experimental

SAR341402 Mix 70/30: single dose injection

Intervention: SAR341402 (Drug)

Reference 1 (R1)

Active Comparator

NovoLog Mix 70/30: single dose injection

Intervention: Insulin Aspart (Drug)

Reference 2 (R2)

Active Comparator

NovoMix30: single dose injection

Intervention: Insulin Aspart (Drug)

Reference 3 (R3)

Experimental

SAR341402 rapid-acting solution: single dose injection

Intervention: SAR341402 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 0 to 4 hours

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

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

Time Frame: 24 hours

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

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

Time Frame: 24 hours

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

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

Time Frame: 0 to 24 hours

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

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

Time Frame: 4 to 12 hours

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

Secondary Outcomes

  • Assessment of PK parameter: Time to Cmax (INS-tmax)(24 hours)
  • 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)(0 to 4 hours)
  • 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)(4 to 12 hours)
  • Assessment of PK parameter: Area under the insulin concentration time curve from 0 to infinity (INS-AUC)(0 to 24 hours)
  • 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)(0 to 4 hours, 0 to 24 hours, and 4 to 24 hours)
  • Assessment of PK parameter: Time to INS-Cmax(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 -)
  • Assessment of PK parameter: Half-life (t1/2)(24 hours)
  • Assessment of PD parameter: GIR versus time curve from 0 to 24 hours post administration (GIR-AUC0-24H)(0 to 24 hours)
  • Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax)(24 hours)
  • Assessment of PD parameter: Time to GIRmax (GIR-tmax)(24 hours)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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