Type 2 Diabetes Mellitus Clinical Trial
Official title:
A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey
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.
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period). ;
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