Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary Objective: To compare between treatment groups: * Plasma glucose (fasting, nocturnal) over time, * Changes from baseline in HbA1c over time, * Percentage of patients who reach the target of HbA1c \<7 and \<6.5, * Use of prandial insulin as rescue medication at month 6, * Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), * Daily dose of insulin, * Change in body weight from baseline, * Evolution of 8-point plasma-glucose (PG) profiles, * Overall safety, * Patient reported outcomes (treatment satisfaction).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
708
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
tablets of 1 and 2 mg
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
Investigational Site Number 076-001
Fortaleza, Brazil
Investigational Site Number 076-006
Fortaleza, Brazil
Investigational Site Number 076-005
Porto Alegre, Brazil
Investigational Site Number 076-007
Rio de Janeiro, Brazil
Investigational Site Number 076-004
São Paulo, Brazil
Investigational Site Number 076-003
HbA1c
Time frame: Recorded at baseline (week 0), week 12, week 24 and week 36
Self-monitored fasting plasma glucose (FPG)
Time frame: Before baseline (week 0), weeks 12, 24 and 36
8-points profiles
Time frame: The week before baseline, at 12, 24 and 36 weeks
Episodes of hypoglycemia
Time frame: From the week -2 to the week 36
Daily doses of insulin
Time frame: At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36
Need of additional prandial insulin
Time frame: At week 24
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São Paulo, Brazil
Investigational Site Number 076-002
São Paulo, Brazil
Investigational Site Number 203003
Beroun, Czechia
Investigational Site Number 203001
Chrudim III, Czechia
Investigational Site Number 203008
České Budějovice, Czechia
...and 77 more locations