Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 12:01 AM
NCT ID: NCT02273258
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.
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.
Study: NCT02273258
Study Brief:
Protocol Section: NCT02273258