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:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT01117350
Brief Summary:
Primary objective:
To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents
Secondary objectives of the comparative period (24 weeks):
\>To assess the effect of insulin glargine in comparison with liraglutide on:
* HbA1c level
* Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period
* Percentage of patients whose HbA1c has increased at the end of the comparative period
* Fasting Plasma Glucose (FPG)
* 7-point Plasma Glucose (PG) profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events
Objectives of the extension period (24 weeks):
\>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:
* HbA1c level
* FPG
* 7-point PG profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events
Detailed Description:
Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:
* A 2-week of screening period,
* A 24-week comparative period,
* A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period),
* A 1-week follow-up period
Study:
NCT01117350
Study Brief:
Protocol Section:
NCT01117350