Primary Objective: Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months Secondary Objectives: * Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months * Insulin glargine dose at 3 and 6 months * Hypoglycemic episodes (all types)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
Investigational Site Number 10
C.a.b.a., Argentina
Investigational Site Number 14
C.a.b.a., Argentina
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.
Time frame: From week 0 (baseline) to week 24 (end of study)
Glycosylated Haemoglobin (HbA1c)
Time frame: From week 0 (baseline) to week 24 (end of study)
Dose and timing of insulin glargine
Time frame: From week 0 (baseline) to week 24 (end of study)
Hypoglycemic episodes
Time frame: From week 0 (baseline) to week 24 (end of study)
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Investigational Site Number 01
C.a.b.a., Argentina
Investigational Site Number 11
C.a.b.a., Argentina
Investigational Site Number 12
C.a.b.a., Argentina
Investigational Site Number 17
C.a.b.a., Argentina
Investigational Site Number 9
C.a.b.a., Argentina
Investigational Site Number 03
Caba, Argentina
Investigational Site Number 06
Caba, Argentina
Investigational Site Number 15
Caba, Argentina
...and 13 more locations