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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

NCT02625636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-23

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

SAR438544

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

placebo

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

r-glucagon

Pharmaceutical form: solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625636 on ClinicalTrials.gov