Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02273258
Status:
COMPLETED
Last Update Posted:
2014-10-23
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2014-10
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 compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.
Secondary Objective:
To assess the safety and tolerability of SAR342434.
To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.
Secondary Objective:
To assess the safety and tolerability of SAR342434.
Detailed Description:
The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)
* Screening: 2 to 28 days (D -28 to D -2)
* Treatment period 1 - 3: 2 days (1 overnight stay)
* Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
* End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.
* Screening: 2 to 28 days (D -28 to D -2)
* Treatment period 1 - 3: 2 days (1 overnight stay)
* Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
* End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.
Study Oversight
Has Oversight DMC:
False
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?: