Primary Objective: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. Secondary Objectives: * Evolution of fasting plasma glucose * Evolution of insulin dose and body weight * Hypoglycemia incidence * Safety * Patients satisfaction when they change their insulin for HOE901-U300
The total study duration per patient is approximately 28 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Pharmaceutical form: solution Route of administration: subcutaneous
Mean change from baseline in HbA1c
Time frame: Baseline, Week 24
Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)
Time frame: At Weeks 12 and 24
Percentage of patients with HbA1c <7%, <7.5%, and <8%
Time frame: At Week 24
Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)
Time frame: Baseline to Week 12 and Week 24
Mean change from baseline in fasting plasma glucose
Time frame: Baseline to Week 12 and Week 24
Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: Baseline to Week 24
Change in Diabetes Treatment Satisfaction Questionnaire score
Time frame: Week 24
Number of hypoglycemic events
Time frame: From inclusion up to Week 24
Number of adverse events
Time frame: From inclusion up to Week 24
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Investigational Site Number 250017
Alençon, France
Investigational Site Number 250073
Alès, France
Investigational Site Number 250047
Amiens, France
Investigational Site Number 250028
Amilly, France
Investigational Site Number 250062
Bagnols-sur-Cèze, France
Investigational Site Number 250093
Bar-le-Duc, France
Investigational Site Number 250020
Besançon, France
Investigational Site Number 250081
Béthune, France
Investigational Site Number 250034
Bondy, France
Investigational Site Number 250022
Brest, France
...and 75 more locations