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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01517412
Brief Summary:
Primary Objective:
\- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
* To assess the effect of the 2 lixisenatide regimens on:
* The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
* Fasting Plasma Glucose (FPG)
* 7-point Self-Monitored Plasma Glucose (SMPG) profiles
* Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens
Detailed Description:
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.
Study:
NCT01517412
Study Brief:
Protocol Section:
NCT01517412