Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c \< 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: * To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c \< 7% and \< 6.5% at the end of the treatment period * To compare the changes in HbA1c and fasting plasma glucose (FPG) * To compare the evolution of blood glucose profiles * To compare the day to day FPG variability, the insulin doses * To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets * To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) * To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL \[3.9 mmol/L\]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL * To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio * To assess the quality of life and treatment satisfaction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
973
Subcutaneous injection, once a day in the evening
Subcutaneous injection, twice a day at breakfast and before dinner
Sanofi-Aventis
North Ryde, Australia
Sanofi-Aventis
São Paulo, Brazil
Sanofi-Aventis
Laval, Canada
Sanofi-Aventis
Hoersholm, Denmark
Sanofi-Aventis
Helsinki, Finland
Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Mumbai, India
Sanofi-Aventis
Dublin, Ireland
Sanofi-Aventis
Gouda, Netherlands
Sanofi-Aventis
Porto Salvo, Portugal
...and 10 more locations
HbA1c recorded
Time frame: At baseline, week 12 and week 24
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
Time frame: On the 4 consecutive days before each visit
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
Time frame: Within the week prior to baseline, week 12 and week 24
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
Time frame: All across the study
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
Time frame: All across the study
Doses of insulin glargine or insulin detemir
Time frame: Daily
Laboratory fasting plasma glucose
Time frame: At baseline, week 12 and week 24
Insulinemia and fasting C-peptide level
Time frame: At baseline
Lipid profile
Time frame: at baseline and week 24
Patient reported outcomes (quality of life and treatment satisfaction)
Time frame: at baseline, week 4, week 12 and at the last visit
Safety data: occurrence of adverse events and weight
Time frame: assessed at each visit
Waist and hip circumferences
Time frame: measured at baseline, week 12 and week 24
Systolic and diastolic blood pressure
Time frame: measured at study entry, baseline, week 12 and week 24
Physical examination
Time frame: performed at study entry and at last visit.
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