A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: SAR438544; Drug: placebo; Drug: r-glucagon

• Registration Number: NCT02625636
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.

Secondary Objective:

To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.

Detailed Description

Healthy subjects:

The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

T1DM patients:

The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

One or more interim analyses may be performed to support decisions for the next steps of the study.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR438544 dose 1	SAR438544	Single dose of SAR438544 given SC under fasting conditions
SAR438544 dose 2	SAR438544	Single dose of SAR438544 given SC under fasting conditions
SAR438544 dose 3	SAR438544	Single dose of SAR438544 given SC under fasting conditions
Placebo	placebo	Single dose of placebo given SC under fasting conditions
Glucagon	r-glucagon	Single dose of glucagon given SC under fasting conditions
SAR438544 Optional Dose	SAR438544	Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Day 1 to Day 7 (+/- 1 day)

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): AUC	Day 1
Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose	Day 1
Assessment of PD parameter: area under plasma concentration of the BG-time curve between investigational medicinal product (IMP) dosing and time t (BG-AUC0-t)	Day 1
Assessment of PD parameter: BG-maximum concentration (BG-Cmax)	Day 1
Assessment of PD parameter: BG-time to Cmax (BG-tmax)	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tmax	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tlast	Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)	Day 1

Trial Locations

Locations (1)

Investigational Site Number 840001; 🇺🇸 Chula Vista, California, United States