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 380007
🇮🇹Forlì, Italy
Investigational Site Number 380012
🇮🇹Milano, Italy
Investigational Site Number 380026
🇮🇹Padova, Italy
Investigational Site Number 380021
🇮🇹Palermo, Italy
Investigational Site Number 380032
🇮🇹Roma, Italy
Investigational Site Number 076006
🇧🇷São paulo, Brazil
Investigational Site Number 826008
🇬🇧Bradford on Avon, United Kingdom
Investigational Site Number 826033
🇬🇧Atherstone, United Kingdom
Investigational Site Number 826016
🇬🇧Ayr, United Kingdom
Investigational Site Number 826025
🇬🇧Huntingdon, United Kingdom
Investigational Site Number 826002
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826013
🇬🇧Taunton, United Kingdom
Investigational Site Number 826021
🇬🇧Plymouth, United Kingdom
Investigational Site Number 826007
🇬🇧Welwyn Garden City, United Kingdom
Investigational Site Number 246007
🇫🇮Muurame, Finland
Investigational Site Number 246009
🇫🇮Pori, Finland
Investigational Site Number 076010
🇧🇷Taguatinga, Brazil
Investigational Site Number 076004
🇧🇷Fortaleza, Brazil
Investigational Site Number 300003
🇬🇷Kalamata, Greece
Investigational Site Number 076-001
🇧🇷Curitiba, Brazil
Investigational Site Number 076008
🇧🇷Fortaleza, Brazil
Investigational Site Number 246001
🇫🇮Oulu, Finland
Investigational Site Number 300002
🇬🇷Athens, Greece
Investigational Site Number 250003
🇫🇷Paris, France
Investigational Site Number 250025
🇫🇷POITIERS Cedex, France
Investigational Site Number 642005
🇷🇴Baia MAre, Romania
Investigational Site Number 380004
🇮🇹Catania, Italy
Investigational Site Number 642007
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 826019
🇬🇧Manchester, United Kingdom
Investigational Site Number 380031
🇮🇹Eboli, Italy
Investigational Site Number 380023
🇮🇹Roma, Italy
Investigational Site Number 724027
🇪🇸Castellón, Spain
Investigational Site Number 724008
🇪🇸Galdakao (Bilbao), Spain
Investigational Site Number 826009
🇬🇧Nuneaton, United Kingdom
Investigational Site Number 724013
🇪🇸Madrid, Spain
Investigational Site Number 380018
🇮🇹Genova, Italy
Investigational Site Number 380020
🇮🇹Iglesias (CI), Italy
Investigational Site Number 380015
🇮🇹Milano, Italy
Investigational Site Number 642006
🇷🇴Brasov, Romania
Investigational Site Number 380006
🇮🇹Catanzaro, Italy
Investigational Site Number 826031
🇬🇧Coventry, United Kingdom
Investigational Site Number 724006
🇪🇸Palma de Mallorca, Spain
Investigational Site Number 826006
🇬🇧Portsmouth, United Kingdom
Investigational Site Number 724012
🇪🇸Barcelona, Spain
Investigational Site Number 724009
🇪🇸Valladolid, Spain
Investigational Site Number 826039
🇬🇧Blackburn, United Kingdom
Investigational Site Number 826004
🇬🇧Chertsey, United Kingdom
Investigational Site Number 380001
🇮🇹Milano, Italy
Investigational Site Number 380011
🇮🇹Orbassano (TO), Italy
Investigational Site Number 380014
🇮🇹Partinico, Italy
Investigational Site Number 642008
🇷🇴Arad, Romania
Investigational Site Number 642002
🇷🇴Brasov, Romania
Investigational Site Number 642003
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 642004
🇷🇴Targu-Mures, Romania
Investigational Site Number 642001
🇷🇴Timisoara, Romania
Investigational Site Number 380036
🇮🇹San Benedetto del Tronto, Italy
Investigational Site Number 380024
🇮🇹Sarzana, Italy
Investigational Site Number 380013
🇮🇹Savigliano (CN), Italy
Investigational Site Number 380025
🇮🇹Torino, Italy
Investigational Site Number 380002
🇮🇹Roma, Italy
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 724011
🇪🇸Barcelona, Spain
Investigational Site Number 724028
🇪🇸Córdoba, Spain
Investigational Site Number 724010
🇪🇸León, Spain
Investigational Site Number 724018
🇪🇸Madrid, Spain
Investigational Site Number 756003
🇨🇭Bern, Switzerland
Investigational Site Number 756002
🇨🇭St. Gallen, Switzerland
Investigational Site Number 826037
🇬🇧Manchester, United Kingdom
Investigational Site Number 826017
🇬🇧Glasgow, United Kingdom
Investigational Site Number 826038
🇬🇧Cornwall, United Kingdom
Investigational Site Number 826024
🇬🇧Darlington, United Kingdom
Investigational Site Number 250009
🇫🇷Caen, France
Investigational Site Number 250026
🇫🇷La Rochelle Cedex 1, France
Investigational Site Number 250008
🇫🇷Amiens Cedex 1, France
Investigational Site Number 250011
🇫🇷Bordeaux, France
Investigational Site Number 250001
🇫🇷Corbeil Essonnes, France
Investigational Site Number 250020
🇫🇷Montpellier, France
Investigational Site Number 250014
🇫🇷Pierre-Bénite, France
Investigational Site Number 250013
🇫🇷Vandoeuvre Les Nancy Cedex, France
Investigational Site Number 724025
🇪🇸Móstoles, Spain
Investigational Site Number 724007
🇪🇸Palma de Mallorca, Spain
Investigational Site Number 724020
🇪🇸Málaga, Spain
Investigational Site Number 724024
🇪🇸Pontevedra, Spain
Investigational Site Number 724017
🇪🇸Sabadell, Spain
Investigational Site Number 724003
🇪🇸San Juan de Alicante, Spain
Investigational Site Number 724030
🇪🇸Sant Joan Despí, Spain
Investigational Site Number 724014
🇪🇸Santiago de Compostela, Spain
Investigational Site Number 724005
🇪🇸Sevilla, Spain
Investigational Site Number 724021
🇪🇸Valencia, Spain
Investigational Site Number 724016
🇪🇸Sevilla, Spain
Investigational Site Number 724004
🇪🇸Sevilla, Spain
Investigational Site Number 724029
🇪🇸Vigo, Spain
Investigational Site Number 724023
🇪🇸Santa Cruz de Tenerife, Spain
Investigational Site Number 076-003
🇧🇷Sao Paulo, Brazil
Investigational Site Number 076009
🇧🇷Rio de Janeiro, Brazil
Investigational Site Number 076011
🇧🇷São José dos Campos, Brazil
Investigational Site Number 076005
🇧🇷São Paulo, Brazil
Investigational Site Number 246008
🇫🇮Helsinki, Finland
Investigational Site Number 246002
🇫🇮Oulu, Finland
Investigational Site Number 246004
🇫🇮Rauma, Finland
Investigational Site Number 250010
🇫🇷Pierre-Bénite, France
Investigational Site Number 250005
🇫🇷Eaubonne, France
Investigational Site Number 250015
🇫🇷Mulhouse, France
Investigational Site Number 250002
🇫🇷Valenciennes, France
Investigational Site Number 300001
🇬🇷Lamia, Greece
Investigational Site Number 300004
🇬🇷Thessaloniki, Greece
Investigational Site Number 380016
🇮🇹Catania, Italy
Investigational Site Number 372003
🇮🇪Dublin 4, Ireland
Investigational Site Number 372002
🇮🇪Dublin 7, Ireland
Investigational Site Number 380033
🇮🇹Arzignano (VI), Italy
Investigational Site Number 380017
🇮🇹Sesto S. Giovanni, Italy
Investigational Site Number 724019
🇪🇸Barcelona, Spain
Investigational Site Number 724022
🇪🇸San Cristóbal De La Laguna - Santa Cruz De Tenerife, Spain
Investigational Site Number 724001
🇪🇸LLeida, Spain
Investigational Site Number 826035
🇬🇧Dudley, United Kingdom
Investigational Site Number 826018
🇬🇧Manchester, United Kingdom
Investigational Site Number 826023
🇬🇧Norwich, United Kingdom
Investigational Site Number 826020
🇬🇧Southampton, United Kingdom