Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02411825
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2015-03-24
Brief Title:
Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus T2DM Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Assess the Safety and Tolerability Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneous Doses of SAR425899 in Healthy Male Subjects and Overweight to Obese Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The total study duration is approximately 10-15 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004216-10 | EUDRACT_NUMBER | None | None |
| U1111-1163-1209 | OTHER | UTN | None |