A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin Lispro; Drug: SAR342434

• Registration Number: NCT02273258
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.

Secondary Objective:

To assess the safety and tolerability of SAR342434.

Detailed Description

The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)

* Screening: 2 to 28 days (D -28 to D -2)

* Treatment period 1 - 3: 2 days (1 overnight stay)

* Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)

* End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-21
• Last Update Submitted: 2014-10-21
• Study First Posted: 2014-10-23
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference 2 (R2)	Insulin Lispro	EU-approved Humalog®: single dose injection
Test (T)	SAR342434	SAR342434: single dose injection
Reference 1 (R1)	Insulin Lispro	US-approved Humalog®: single dose injection

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog	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)	12 hours
Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog	12 hours

Secondary Outcome Measures

Name	Time	Method
Time to 20% of AUC (t20%-AUC)	12 hours
Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)	12 hours
The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)	12 hours
Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia	8 weeks
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)	12 hours
The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)	12 hours
NS-tmax, INS-t1/2z	12 hours
Maximum smoothed body weight standardized GIR (GIRmax)	12 hours
Time to GIRmax (GIR-tmax)	12 hours

Trial Locations

Locations (1)

Sanofi Administrative Office; 🇩🇪 Frankfurt, Germany