Clinical trial NCT02967211: 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
Official title: A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria :

* Patients with type 2 diabetes insufficiently controlled (HbA1c \>7%) with current (≥6 months) "standard of care" basal insulin therapy (including insulin glargine U100, Levemir, NPH, or Tresiba) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without use of a GLP-1 receptor agonist.
* Fasting plasma glucose (FPG) \>130 mg/dL (7.2 mmol/L).
* Adult patients who have signed Informed Consent Form (ICF) and privacy form(s).

Exclusion criteria:

* HbA1c ≤7%, no upper bound.
* Age \<18 years.
* Type 1 diabetes mellitus.
* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
* Use of any product containing short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization.
* Use of any product containing short or rapid acting insulin occurring within 3 months prior to the time of screening.
* Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
* All contraindications to "standard of care" insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
* Hypersensitivity to insulin glargine or Toujeo excipients.
* Pregnancy or lactation.
* Women of childbearing potential with no effective contraceptive method.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in HbA1c (percentage %)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
timeFrame: At Month 6 and Month 12
measure: Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
timeFrame: At Month 6 and Month 12
measure: Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
timeFrame: At Month 6 and Month 12
measure: 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
timeFrame: At Month 6 and Month 12
measure: 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
timeFrame: At Month 6 and Month 12
measure: Change in HbA1c (percentage %)
timeFrame: Baseline, Month 12
measure: Percentage of patients whose HbA1c decreased at least 0.5%
timeFrame: At Month 6 and Month 12
measure: Percentage of patients whose HbA1c decreased at least 0.5%
timeFrame: At Month 6 and maintained at Month 12
measure: Percentage of patients requiring intensification
timeFrame: At Month 6 and Month 12
measure: Time to intensification
timeFrame: At Month 6 and Month 12
measure: Change in fasting plasma glucose
timeFrame: From baseline to Month 6 and Month 12
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Investigational Site Number 076-001
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076008
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076004
city: Rio de Janeiro
country: Brazil
facility: Investigational Site Number 076009
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076-003
city: São José dos Campos
country: Brazil
facility: Investigational Site Number 076011
city: São paulo
country: Brazil
facility: Investigational Site Number 076006
city: São Paulo
country: Brazil
facility: Investigational Site Number 076005
city: Taguatinga
country: Brazil
facility: Investigational Site Number 076010
city: Helsinki
country: Finland
facility: Investigational Site Number 246008
city: Muurame
country: Finland
facility: Investigational Site Number 246007
city: Oulu
country: Finland
facility: Investigational Site Number 246002
city: Oulu
country: Finland
facility: Investigational Site Number 246001
city: Pori
country: Finland
facility: Investigational Site Number 246009
city: Rauma
country: Finland
facility: Investigational Site Number 246004
city: Amiens Cedex 1
country: France
facility: Investigational Site Number 250008
city: Bordeaux
country: France
facility: Investigational Site Number 250011
city: Caen
country: France
facility: Investigational Site Number 250009
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250001
city: Eaubonne
country: France
facility: Investigational Site Number 250005
city: La Rochelle Cedex 1
country: France
facility: Investigational Site Number 250026
city: Montpellier
country: France
facility: Investigational Site Number 250020
city: Mulhouse
country: France
facility: Investigational Site Number 250015
city: Paris
country: France
facility: Investigational Site Number 250003
city: Pierre-Bénite
country: France
facility: Investigational Site Number 250010
city: Pierre-Bénite
country: France
facility: Investigational Site Number 250014
city: POITIERS Cedex
country: France
facility: Investigational Site Number 250025
city: Valenciennes
country: France
facility: Investigational Site Number 250002
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Investigational Site Number 250013
city: Athens
country: Greece
facility: Investigational Site Number 300002
city: Kalamata
country: Greece
facility: Investigational Site Number 300003
city: Lamia
country: Greece
facility: Investigational Site Number 300001
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300004
city: Dublin 4
country: Ireland
facility: Investigational Site Number 372003
city: Dublin 7
country: Ireland
facility: Investigational Site Number 372002
city: Arzignano (VI)
country: Italy
facility: Investigational Site Number 380033
city: Catania
country: Italy
facility: Investigational Site Number 380016
city: Catania
country: Italy
facility: Investigational Site Number 380004
city: Catanzaro
country: Italy
facility: Investigational Site Number 380006
city: Eboli
country: Italy
facility: Investigational Site Number 380031
city: Forlì
country: Italy
facility: Investigational Site Number 380007
city: Genova
country: Italy
facility: Investigational Site Number 380018
city: Iglesias (CI)
country: Italy
facility: Investigational Site Number 380020
city: Milano
country: Italy
facility: Investigational Site Number 380015
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Milano
country: Italy
facility: Investigational Site Number 380012
city: Orbassano (TO)
country: Italy
facility: Investigational Site Number 380011
city: Padova
country: Italy
facility: Investigational Site Number 380026
city: Palermo
country: Italy
facility: Investigational Site Number 380021
city: Partinico
country: Italy
facility: Investigational Site Number 380014
city: Roma
country: Italy
facility: Investigational Site Number 380032
city: Roma
country: Italy
facility: Investigational Site Number 380002
city: Roma
country: Italy
facility: Investigational Site Number 380023
city: San Benedetto del Tronto
country: Italy
facility: Investigational Site Number 380036
city: Sarzana
country: Italy
facility: Investigational Site Number 380024
city: Savigliano (CN)
country: Italy
facility: Investigational Site Number 380013
city: Sesto S. Giovanni
country: Italy
facility: Investigational Site Number 380017
city: Torino
country: Italy
facility: Investigational Site Number 380025
city: Arad
country: Romania
facility: Investigational Site Number 642008
city: Baia MAre
country: Romania
facility: Investigational Site Number 642005
city: Brasov
country: Romania
facility: Investigational Site Number 642002
city: Brasov
country: Romania
facility: Investigational Site Number 642006
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642003
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642007
city: Targu-Mures
country: Romania
facility: Investigational Site Number 642004
city: Timisoara
country: Romania
facility: Investigational Site Number 642001
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724019
city: Barcelona
country: Spain
facility: Investigational Site Number 724012
city: Barcelona
country: Spain
facility: Investigational Site Number 724011
city: Castellón
country: Spain
facility: Investigational Site Number 724027
city: Córdoba
country: Spain
facility: Investigational Site Number 724028
city: Galdakao (Bilbao)
country: Spain
facility: Investigational Site Number 724008
city: León
country: Spain
facility: Investigational Site Number 724010
city: LLeida
country: Spain
facility: Investigational Site Number 724001
city: Madrid
country: Spain
facility: Investigational Site Number 724013
city: Madrid
country: Spain
facility: Investigational Site Number 724018
city: Málaga
country: Spain
facility: Investigational Site Number 724020
city: Móstoles
country: Spain
facility: Investigational Site Number 724025
city: Palma de Mallorca
country: Spain
facility: Investigational Site Number 724006
city: Palma de Mallorca
country: Spain
facility: Investigational Site Number 724007
city: Pontevedra
country: Spain
facility: Investigational Site Number 724024
city: Sabadell
country: Spain
facility: Investigational Site Number 724017
city: San Cristóbal De La Laguna - Santa Cruz De Tenerife
country: Spain
facility: Investigational Site Number 724022
city: San Juan de Alicante
country: Spain
facility: Investigational Site Number 724003
city: Sant Joan Despí
country: Spain
facility: Investigational Site Number 724030
city: Santa Cruz de Tenerife
country: Spain
facility: Investigational Site Number 724023
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number 724014
city: Sevilla
country: Spain
facility: Investigational Site Number 724005
city: Sevilla
country: Spain
facility: Investigational Site Number 724016
city: Sevilla
country: Spain
facility: Investigational Site Number 724004
city: Valencia
country: Spain
facility: Investigational Site Number 724021
city: Valladolid
country: Spain
facility: Investigational Site Number 724009
city: Vigo
country: Spain
facility: Investigational Site Number 724029
city: Bern
country: Switzerland
facility: Investigational Site Number 756003
city: St. Gallen
country: Switzerland
facility: Investigational Site Number 756002
city: Atherstone
country: United Kingdom
facility: Investigational Site Number 826033
city: Ayr
country: United Kingdom
facility: Investigational Site Number 826016
city: Blackburn
country: United Kingdom
facility: Investigational Site Number 826039
city: Bradford on Avon
country: United Kingdom
facility: Investigational Site Number 826008
city: Chertsey
country: United Kingdom
facility: Investigational Site Number 826004
city: Cornwall
country: United Kingdom
facility: Investigational Site Number 826038
city: Coventry
country: United Kingdom
facility: Investigational Site Number 826031
city: Darlington
country: United Kingdom
facility: Investigational Site Number 826024
city: Dudley
country: United Kingdom
facility: Investigational Site Number 826035
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 826017
city: Huntingdon
country: United Kingdom
facility: Investigational Site Number 826025
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826002
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826018
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826019
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826037
city: Norwich
country: United Kingdom
facility: Investigational Site Number 826023
city: Nuneaton
country: United Kingdom
facility: Investigational Site Number 826009
city: Plymouth
country: United Kingdom
facility: Investigational Site Number 826021
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number 826006
city: Southampton
country: United Kingdom
facility: Investigational Site Number 826020
city: Taunton
country: United Kingdom
facility: Investigational Site Number 826013
city: Welwyn Garden City
country: United Kingdom
facility: Investigational Site Number 826007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
citation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyen-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.