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
- Registration Number
- NCT03916601
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test (T) SAR341402 SAR341402 Mix 70/30: single dose injection Reference 3 (R3) SAR341402 SAR341402 rapid-acting solution: single dose injection Reference 2 (R2) Insulin Aspart NovoMix30: single dose injection Reference 1 (R1) Insulin Aspart NovoLog Mix 70/30: single dose injection
- Primary Outcome Measures
Name Time Method (Cohort 1) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax) 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) 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) 4 to 12 hours INS-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 4 to 12 hours
(Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H) 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) 24 hours (Cohort 2) Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 24 hours
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter: Time to Cmax (INS-tmax) 24 hours (Cohort 2) INS-tmax for SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 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 (Cohort 2) GIR-AUC0-4H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 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 (Cohort 2) GIR-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 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 (Cohort 1) INS-AUC for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30 from 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 (Cohort 1) INS-AUC0-4H, INS-AUC0-24H, INS-AUC4-24H for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30
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 - (Cohort 1) INS-tmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours
Assessment of PK parameter: Half-life (t1/2) 24 hours (Cohort 1) INS-t1/2z for SAR341402 Mix 70/30, Novolog Mix 70/30 and NovoMix 30 within 24 hours
Assessment of PD parameter: GIR versus time curve from 0 to 24 hours post administration (GIR-AUC0-24H) 0 to 24 hours (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
Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax) 24 hours (Cohort 2) GIRmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours
Assessment of PD parameter: Time to GIRmax (GIR-tmax) 24 hours (Cohort 2) GIR-tmax for SAR341402 Mix 70/30, Novolog Mix 70/30, NovoMix 30 and SAR341402 rapid acting solution within 24 hours
Trial Locations
- Locations (1)
Investigational Site Number 2760001
š©šŖNeuss, Germany