A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: insulin glargine (U100)Drug: NPH insulin
- Registration Number
- NCT02967224
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change
Secondary Objectives:
* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as 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 the incidence of documented symptomatic or severe hypoglycemic events \[as defined by the American Diabetes Association (ADA\] Workgroup on Hypoglycemia).
* 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
- 705
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 or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents Toujeo insulin glargine (U300) Toujeo will be administered once daily in addition to noninsulin antidiabetic agents "Standard of care" commercially available basal insulin insulin glargine (U100) Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents "Standard of care" commercially available basal insulin insulin degludec Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents "Standard of care" commercially available basal insulin insulin detemir Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
- Primary Outcome Measures
Name Time Method Change in HbA1c (percentage %) Baseline to 6 Months
- Secondary Outcome Measures
Name Time Method Percentage of patients whose HbA1c decreased at least 1% At Month 6 and maintained at Month 12 Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%) At Month 6 and Month 12 Time to intensification 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 to Month 12 Change in fasting plasma glucose Baseline to Month 6 and Month 12 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 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 hypoglycemia At Month 6 and Month 12 Percentage of patients requiring intensification At Month 6 and Month 12
Related Research Topics
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Trial Locations
- Locations (128)
Investigational Site Number 372003
🇮🇪Dublin 4, Ireland
Investigational Site Number 327002
🇮🇪Dublin 7, Ireland
Investigational Site Number 250045
🇫🇷Montpellier, France
Investigational Site Number 250016
🇫🇷Montpellier, France
Investigational Site Number 076005
🇧🇷Fortaleza, Brazil
Investigational Site Number 076010
🇧🇷Taguatinga, Brazil
Investigational Site Number 076011
🇧🇷São José dos Campos, Brazil
Investigational Site Number 250058
🇫🇷La Rochelle Cedex 1, France
Investigational Site Number 076007
🇧🇷São paulo, Brazil
Investigational Site Number 250008
🇫🇷BOIS GUILLAUME Cedex, France
Investigational Site Number 250024
🇫🇷Bordeaux, France
Investigational Site Number 250028
🇫🇷Brest, France
Investigational Site Number 250063
🇫🇷Paris, France
Investigational Site Number 250053
🇫🇷Paris, France
Investigational Site Number 250014
🇫🇷Caen, France
Investigational Site Number 250017
🇫🇷Le Puy En Velay Cedex, France
Investigational Site Number 250009
🇫🇷Venissieux, France
Investigational Site Number 076-001
🇧🇷Curitiba, Brazil
Investigational Site Number 250043
🇫🇷Tarbes, France
Investigational Site Number 250030
🇫🇷Pierre-Bénite, France
Investigational Site Number 250025
🇫🇷Corbeil Essonnes, France
Investigational Site Number 250011
🇫🇷Eaubonne, France
Investigational Site Number 250034
🇫🇷Lamagistere, France
Investigational Site Number 250039
🇫🇷Reims Cedex, France
Investigational Site Number 250057
🇫🇷Bar le Duc, France
Investigational Site Number 250050
🇫🇷BETHUNE Cedex, France
Investigational Site Number 250003
🇫🇷CAHORS Cedex 9, France
Investigational Site Number 250064
🇫🇷CHALONS EN CHAMPAGNE Cedex, France
Investigational Site Number 250026
🇫🇷Cholet, France
Investigational Site Number 076008
🇧🇷Sao Paulo, Brazil
Investigational Site Number 250060
🇫🇷Alencon Cedex, France
Investigational Site Number 076003
🇧🇷São Paulo, Brazil
Investigational Site Number 250023
🇫🇷Amiens Cedex 1, France
Investigational Site Number 250013
🇫🇷La Roche Sur Yon, France
Investigational Site Number 250027
🇫🇷La Seyne sur Mer, France
Investigational Site Number 724006
🇪🇸Majadahonda, Spain
Investigational Site Number 724025
🇪🇸Madrid, Spain
Investigational Site Number 826006
🇬🇧Portsmouth, United Kingdom
Investigational Site Number 276013
🇩🇪Bornheim, Germany
Investigational Site Number 250044
🇫🇷Orleans, France
Investigational Site Number 076004
🇧🇷Fortaleza, Brazil
Investigational Site Number 076009
🇧🇷Rio de Janeiro, Brazil
Investigational Site Number 250012
🇫🇷Marseille, France
Investigational Site Number 250054
🇫🇷Maubeuge, France
Investigational Site Number 250020
🇫🇷Montpellier, France
Investigational Site Number 250046
🇫🇷Nevers, France
Investigational Site Number 250041
🇫🇷Nimes, France
Investigational Site Number 250004
🇫🇷NARBONNE Cedex, France
Investigational Site Number 250035
🇫🇷Mulhouse, France
Investigational Site Number 250032
🇫🇷Paris, France
Investigational Site Number 250005
🇫🇷Paris, France
Investigational Site Number 250021
🇫🇷Pierre-Bénite, France
Investigational Site Number 250052
🇫🇷POITIERS Cedex, France
Investigational Site Number 250051
🇫🇷PRINGY Cedex, France
Investigational Site Number 250022
🇫🇷Roubaix, France
Investigational Site Number 250055
🇫🇷Sete, France
Investigational Site Number 250033
🇫🇷Saint-Mandé, France
Investigational Site Number 250056
🇫🇷Strasbourg, France
Investigational Site Number 250031
🇫🇷Strasbourg Cedex 2, France
Investigational Site Number 250001
🇫🇷Strasbourg, France
Investigational Site Number 250029
🇫🇷Vandoeuvre Les Nancy Cedex, France
Investigational Site Number 250002
🇫🇷Toulouse Cedex 3, France
Investigational Site Number 250007
🇫🇷VICHY Cedex, France
Investigational Site Number 250059
🇫🇷Villeneuve sur Lot, France
Investigational Site Number 250006
🇫🇷Vichy, France
Investigational Site Number 276001
🇩🇪Dresden, Germany
Investigational Site Number 276016
🇩🇪Hamburg, Germany
Investigational Site Number 276014
🇩🇪Hohenmölsen, Germany
Investigational Site Number 276002
🇩🇪Dresden, Germany
Investigational Site Number 276008
🇩🇪Oldenburg, Germany
Investigational Site Number 276017
🇩🇪Münster, Germany
Investigational Site Number 276006
🇩🇪Pirna, Germany
Investigational Site Number 276010
🇩🇪Rehlingen-Siersburg, Germany
Investigational Site Number 276005
🇩🇪Riesa, Germany
Investigational Site Number 276009
🇩🇪Neuwied, Germany
Investigational Site Number 276012
🇩🇪Neumünster, Germany
Investigational Site Number 276011
🇩🇪Schweinfurt, Germany
Investigational Site Number 276007
🇩🇪Sulzbach-Rosenberg, Germany
Investigational Site Number 642001
🇷🇴Bucuresti, Romania
Investigational Site Number 642002
🇷🇴Bucuresti, Romania
Investigational Site Number 642005
🇷🇴Galati, Romania
Investigational Site Number 642009
🇷🇴Iasi, Romania
Investigational Site Number 642008
🇷🇴Targoviste, Romania
Investigational Site Number 724013
🇪🇸Almansa, Spain
Investigational Site Number 724016
🇪🇸Barakaldo, Spain
Investigational Site Number 642006
🇷🇴Oradea, Romania
Investigational Site Number 724024
🇪🇸Badalona, Spain
Investigational Site Number 724019
🇪🇸Barcelona, Spain
Investigational Site Number 724005
🇪🇸Barcelona, Spain
Investigational Site Number 724008
🇪🇸Burgos, Spain
Investigational Site Number 724017
🇪🇸Barcelona, Spain
Investigational Site Number 724018
🇪🇸Donostia, Spain
Investigational Site Number 724026
🇪🇸Ferrol, Spain
Investigational Site Number 724014
🇪🇸La Coruña, Spain
Investigational Site Number 724021
🇪🇸Gerona, Spain
Investigational Site Number 724027
🇪🇸Huelva, Spain
Investigational Site Number 724001
🇪🇸LLeida, Spain
Investigational Site Number 724022
🇪🇸Valencia, Spain
Investigational Site Number 724012
🇪🇸Sabadell, Spain
Investigational Site Number 724030
🇪🇸Málaga, Spain
Investigational Site Number 724028
🇪🇸Madrid, Spain
Investigational Site Number 724020
🇪🇸Málaga, Spain
Investigational Site Number 724011
🇪🇸Sevilla, Spain
Investigational Site Number 724010
🇪🇸Sevilla, Spain
Investigational Site Number 724009
🇪🇸Santiago de Compostela, Spain
Investigational Site Number 724007
🇪🇸Vitoria, Spain
Investigational Site Number 724002
🇪🇸Valencia, Spain
Investigational Site Number 826033
🇬🇧Atherstone, United Kingdom
Investigational Site Number 826008
🇬🇧Bradford on Avon, United Kingdom
Investigational Site Number 826016
🇬🇧Ayr, United Kingdom
Investigational Site Number 826004
🇬🇧Chertsey, United Kingdom
Investigational Site Number 826011
🇬🇧Chesterfield, United Kingdom
Investigational Site Number 826028
🇬🇧Chippenham, United Kingdom
Investigational Site Number 826027
🇬🇧Cornwall, United Kingdom
Investigational Site Number 826003
🇬🇧Craigavon, United Kingdom
Investigational Site Number 826038
🇬🇧Cornwall, United Kingdom
Investigational Site Number 826031
🇬🇧Coventry, United Kingdom
Investigational Site Number 826035
🇬🇧Dudley, United Kingdom
Investigational Site Number 826019
🇬🇧Manchester, United Kingdom
Investigational Site Number 826015
🇬🇧Larbert, United Kingdom
Investigational Site Number 826002
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826018
🇬🇧Manchester, United Kingdom
Investigational Site Number 826021
🇬🇧Plymouth, United Kingdom
Investigational Site Number 826009
🇬🇧Nuneaton, United Kingdom
Investigational Site Number 826020
🇬🇧Southampton, United Kingdom
Investigational Site Number 826013
🇬🇧Taunton, United Kingdom
Investigational Site Number 642007
🇷🇴Bucuresti, Romania
Investigational Site Number 642004
🇷🇴Cluj-Napoca, Romania