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

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: SAR341402; Drug: Insulin Aspart

• Registration Number: NCT03202875
• Lead Sponsor: Sanofi

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.

Detailed Description

The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the investigational product.

Study Timeline

• Study Start: 2012-11-14
• Primary Completion: 2012-12-28
• Study Completion: 2012-12-28
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test (T)	SAR341402	SAR341402: single dose injection
Reference 1 (R1)	Insulin Aspart	NovoRapid®: single dose injection
Reference 2 (R2)	Insulin Aspart	NovoLog®: single dose injection

Primary Outcome Measures

Name	Time	Method
Assessment of PK parameters: Area under the concentration versus time curve (AUC)	12 hours	INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR)	12 hours	Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)
Assessment of PK parameters: maximum plasma concentration (Cmax)	12 hours	Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours
Assessment of PK parameter: AUC from dosing to last concentration (AUClast)	12 hours	INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours

Secondary Outcome Measures

Name	Time	Method
Assessment of PD: Time to 20 % of total GIR-AUC0-12h	12 hours	Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h) within 12 hours
Assessment of PD: Fractional area under the body weight standardized GIR versus time curve	12 hours	GIR-AUC0-2 and GIR-AUC4-12
Assessment of PK: Fractional area under the concentration versus time curve	12 hours	INS-AUC0-2 and INS-AUC4-tlast
Number of adverse events (AEs)	8 weeks	Number of patients with treatment emergent AEs and serious adverse events (SAEs)
Assessment of PK: time to reach INS-t1/2z (INS-t1/2z)	12 hours	INS-t1/2z within 12 hours
Assessment of PD: Maximum smoothed body weight standardized GIR (GIRmax)	12 hours	Maximum smoothed body weight standardized GIR (GIRmax) within 12 hours
Assessment of PK: Time to 20 % of INS-AUC	12 hours	Time to 20% of AUC (t20%-INS-AUC) within 12 hours
Assessment of PK: time to reach INS-Cmax (INS-tmax)	12 hours	INS-tmax within 12 hours
Assessment of PD: Time to GIRmax (GIR-tmax)	12 hours	Time to GIRmax (GIR-tmax) within 12 hours

Trial Locations

Locations (1)

Investigational Site 276001; 🇩🇪 Neuss, Germany