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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Pharmaceutical form: pen for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: pen for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Unnamed facility
Turkey, Turkey (Türkiye)
Mean change from baseline in HbA1c
Time frame: Baseline, Week 24
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL
Time frame: At Weeks 12 and 24
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)
Time frame: At Weeks 12 and 24
Duration to reach target pre-breakfast SMBG
Time frame: Baseline, Week 24
Mean change from baseline in HbA1c
Time frame: Baseline, Week 12
Mean change from baseline in SMBG
Time frame: Baseline, Weeks 12, and 24
Mean change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Weeks 12, and 24
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores
Time frame: Baseline, Week 24
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