Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: * To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change. * To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. * Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group). * Change in fasting plasma glucose (FPG). * Change in body weight. * Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc). * Change in hypoglycemic control subscale (HCS). * Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
The total study duration will be up to 55 weeks, consisting of a 1 week screening period at the site, a 26 week treatment period, and a 26 week extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
609
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Investigational Site Number 076-001
Curitiba, Brazil
Investigational Site Number 076008
Fortaleza, Brazil
Investigational Site Number 076004
Fortaleza, Brazil
Investigational Site Number 076009
Rio de Janeiro, Brazil
Investigational Site Number 076011
São José dos Campos, Brazil
Investigational Site Number 076006
Change in HbA1c (percentage %)
Time frame: Baseline to 6 months
Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
Time frame: At Month 6 and Month 12
Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
Time frame: At Month 6 and Month 12
Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
Time frame: At Month 6 and Month 12
Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dl [3.9 mmol/L]) symptomatic or severe
Time frame: At Month 6 and Month 12
Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG <54 mg/dL, [3.0 mmol/L]) symptomatic or severe hypoglycemia
Time frame: At Month 6 and Month 12
Change in HbA1c (percentage %)
Time frame: Baseline, Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Time frame: At Month 6 and Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Time frame: At Month 6 and maintained at Month 12
Percentage of patients requiring intensification
Time frame: At Month 6 and Month 12
Time to intensification
Time frame: At Month 6 and Month 12
Change in fasting plasma glucose
Time frame: From baseline to Month 6 and Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
São Paulo, Brazil
Investigational Site Number 076-003
São Paulo, Brazil
Investigational Site Number 076005
São Paulo, Brazil
Investigational Site Number 076010
Taguatinga, Brazil
Investigational Site Number 246008
Helsinki, Finland
...and 108 more locations