Recent Updates
Recently added Catalysts

SAR438544

Phase 1

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Aug 23, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

SAR438544 · 1 trial · 1 indication

Phase 1 1
NCT02625636A 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 PatientsType 1 Diabetes Mellitus
COMPLETED20 Analytics
PHASE1COMPLETED
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
Type 1 Diabetes Mellitus
NCT0262563620
Unlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAR438544 dose 1EXPERIMENTALSingle dose of SAR438544 given SC under fasting conditions
SAR438544 dose 2EXPERIMENTALSingle dose of SAR438544 given SC under fasting conditions
SAR438544 dose 3EXPERIMENTALSingle dose of SAR438544 given SC under fasting conditions
PlaceboPLACEBO_COMPARATORSingle dose of placebo given SC under fasting conditions
GlucagonACTIVE_COMPARATORSingle dose of glucagon given SC under fasting conditions
SAR438544 Optional DoseEXPERIMENTALOptional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions

Interventions

NameTypeDescription
SAR438544DRUGPharmaceutical form: solution Route of administration: subcutaneous
placeboDRUGPharmaceutical form: solution Route of administration: subcutaneous
r-glucagonDRUGPharmaceutical form: solution Route of administration: subcutaneous
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria : Healthy subjects: * Male or female subjects, between 18 and 45 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive. * Certified ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about SAR438544

What is SAR438544 used for?

SAR438544 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, pharmacokinetics, and pharmacodynamics in patients with Type 1 Diabetes Mellitus.

What does SAR438544 target?

The molecular target of SAR438544 has not been disclosed. The drug is a small molecule being developed for Type 1 Diabetes Mellitus, and its mechanism of action is not publicly specified in available clinical trial information.

Who makes SAR438544?

SAR438544 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.

What phase is SAR438544 in?

SAR438544 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage clinical trials to assess its safety, pharmacokinetics, and pharmacodynamics.

What clinical trials is SAR438544 in?

SAR438544 has one completed Phase 1 clinical trial registered as NCT02625636. This study evaluated escalating doses of SAR438544 compared to placebo and glucagon in healthy subjects and patients with Type 1 Diabetes Mellitus. The trial enrolled 20 participants and was conducted in the United States.

Is SAR438544 the same as glucagon?

No, SAR438544 is not the same as glucagon. In the clinical trial NCT02625636, SAR438544 was compared to both placebo and glucagon as reference treatments. SAR438544 is a separate investigational small molecule being developed by Sanofi for Type 1 Diabetes Mellitus.