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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02954692
Brief Summary:
Primary Objective:
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
* Targeted HbA1c;
* Targeted fasting self- monitoring blood glucose (SMBG);
* Hypoglycemic events;
* Adverse events;
* Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
* Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
Detailed Description:
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).
Study:
NCT02954692
Study Brief:
Protocol Section:
NCT02954692