Primary Objective: To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus. Secondary Objectives: * To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. * To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). * To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). * To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). * To assess the safety and tolerability of insulin glargine (U300). * To assess the development of anti-insulin glargine antibodies (AIA).
The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
604
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: capsule/tablet Route of administration: oral
Investigational Site Number 1560039
Beijing, China
Investigational Site Number 1560001
Beijing, China
Investigational Site Number 1560017
Beijing, China
Investigational Site Number 1560003
Beijing, China
Investigational Site Number 1560033
Changchun, China
Investigational Site Number 1560016
Change in HbA1c from baseline
Time frame: Baseline, 6 months
Percentage (%) of patients with at least one hypoglycemia
Time frame: Baseline, up to 6 months
Percentage (%) of patients with at least one nocturnal hypoglycemia
Time frame: Baseline, up to 6 months
Percentage (%) of patients with HbA1c <7.0%
Time frame: 6 months
Percentage (%) of patients with HbA1c ≤6.5%
Time frame: 6 months
Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)
Time frame: 6 months
Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)
Time frame: 6 months
Percentage (%) of patients requiring rescue therapy
Time frame: 6 months
Change in fasting plasma glucose
Time frame: Baseline, 6 months
Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles
Time frame: Baseline, 6 months
Change of mean 24-hour plasma glucose
Time frame: Baseline, 6 months
Change in variability of plasma glucose profile
Time frame: Baseline, 6 months
Change in daily basal insulin dose
Time frame: Baseline, 6 months
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Changzhou, China
Investigational Site Number 1560049
Changzhou, China
Investigational Site Number 1560006
Fuzhou, China
Investigational Site Number 1560004
Guangzhou, China
Investigational Site Number 1560036
Guangzhou, China
...and 44 more locations