A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: insulin glargine (U100)Drug: NPH insulin
- Registration Number
- NCT02967211
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 609
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Standard of care" commercially available basal insulin NPH insulin Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents Toujeo insulin glargine (U300) Toujeo will be administered once daily in addition to non-insulin antidiabetic agents "Standard of care" commercially available basal insulin insulin glargine (U100) Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents "Standard of care" commercially available basal insulin insulin detemir Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents "Standard of care" commercially available basal insulin insulin degludec Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents
- Primary Outcome Measures
Name Time Method Change in HbA1c (percentage %) Baseline to 6 months
- Secondary Outcome Measures
Name Time Method Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy) At Month 6 and Month 12 Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not At Month 6 and Month 12 Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%) 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 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 At Month 6 and Month 12 Change in HbA1c (percentage %) Baseline, Month 12 Percentage of patients whose HbA1c decreased at least 0.5% At Month 6 and maintained at Month 12 Percentage of patients requiring intensification At Month 6 and Month 12 Time to intensification At Month 6 and Month 12 Change in fasting plasma glucose From baseline to Month 6 and Month 12
Trial Locations
- Locations (118)
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 076-003
🇧🇷Sao Paulo, Brazil
Investigational Site Number 076011
🇧🇷São José dos Campos, Brazil
Investigational Site Number 076006
🇧🇷São paulo, Brazil
Investigational Site Number 076005
🇧🇷São Paulo, Brazil
Investigational Site Number 076010
🇧🇷Taguatinga, Brazil
Investigational Site Number 246008
🇫🇮Helsinki, Finland
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