MedTrace Logo

Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients

NCT02411825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-06-15

No results posted yet for this study

Summary

Primary Objective:

To assess in healthy adult male subjects:

* The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899 including two up titration steps.
* Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in plasma.
* Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin, biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).

To assess in overweight to obese T2DM mellitus patients:

* The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up titration steps.
* PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.
* PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin panel (total and active ghrelin, total peptide YY \[PYY\], total and active glucagon-like peptide -1 \[GLP-1\], glucagon and total gastric inhibitory polypeptide-1 \[GIP\]), body weight, FGF21, biomarkers of lipid metabolism and HbA1c.

Conditions

Interventions

DRUG

SAR425899

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

metformin

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02411825 on ClinicalTrials.gov