Clinical trial NCT02967224: 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
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 Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-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: 705
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 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.

Eligibility criteria: Inclusion criteria :

Patients with type 2 diabetes insufficiently controlled (HbA1c \>7%) with current (≥6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinediones, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without GLP-1 receptor agonist, and eligible to basal insulin treatment, per investigator's judgment.

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 insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization.
* Use of any product containing 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 commercially available 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.
* Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* 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 hypoglycemia
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 to Month 12
measure: Percentage of patients whose HbA1c decreased at least 1%
timeFrame: At Month 6 and Month 12
measure: Percentage of patients whose HbA1c decreased at least 1%
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: 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 076005
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 076008
city: São José dos Campos
country: Brazil
facility: Investigational Site Number 076011
city: São paulo
country: Brazil
facility: Investigational Site Number 076007
city: São Paulo
country: Brazil
facility: Investigational Site Number 076003
city: Taguatinga
country: Brazil
facility: Investigational Site Number 076010
city: Alencon Cedex
country: France
facility: Investigational Site Number 250060
city: Amiens Cedex 1
country: France
facility: Investigational Site Number 250023
city: Bar le Duc
country: France
facility: Investigational Site Number 250057
city: BETHUNE Cedex
country: France
facility: Investigational Site Number 250050
city: BOIS GUILLAUME Cedex
country: France
facility: Investigational Site Number 250008
city: Bordeaux
country: France
facility: Investigational Site Number 250024
city: Brest
country: France
facility: Investigational Site Number 250028
city: Caen
country: France
facility: Investigational Site Number 250014
city: CAHORS Cedex 9
country: France
facility: Investigational Site Number 250003
city: CHALONS EN CHAMPAGNE Cedex
country: France
facility: Investigational Site Number 250064
city: Cholet
country: France
facility: Investigational Site Number 250026
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250025
city: Eaubonne
country: France
facility: Investigational Site Number 250011
city: La Roche Sur Yon
country: France
facility: Investigational Site Number 250013
city: La Rochelle Cedex 1
country: France
facility: Investigational Site Number 250058
city: La Seyne sur Mer
country: France
facility: Investigational Site Number 250027
city: Lamagistere
country: France
facility: Investigational Site Number 250034
city: Le Puy En Velay Cedex
country: France
facility: Investigational Site Number 250017
city: Marseille
country: France
facility: Investigational Site Number 250012
city: Maubeuge
country: France
facility: Investigational Site Number 250054
city: Montpellier
country: France
facility: Investigational Site Number 250045
city: Montpellier
country: France
facility: Investigational Site Number 250020
city: Montpellier
country: France
facility: Investigational Site Number 250016
city: Mulhouse
country: France
facility: Investigational Site Number 250035
city: NARBONNE Cedex
country: France
facility: Investigational Site Number 250004
city: Nevers
country: France
facility: Investigational Site Number 250046
city: Nimes
country: France
facility: Investigational Site Number 250041
city: Orleans
country: France
facility: Investigational Site Number 250044
city: Paris
country: France
facility: Investigational Site Number 250063
city: Paris
country: France
facility: Investigational Site Number 250053
city: Paris
country: France
facility: Investigational Site Number 250005
city: Paris
country: France
facility: Investigational Site Number 250032
city: Pierre-Bénite
country: France
facility: Investigational Site Number 250021
city: Pierre-Bénite
country: France
facility: Investigational Site Number 250030
city: POITIERS Cedex
country: France
facility: Investigational Site Number 250052
city: PRINGY Cedex
country: France
facility: Investigational Site Number 250051
city: Reims Cedex
country: France
facility: Investigational Site Number 250039
city: Roubaix
country: France
facility: Investigational Site Number 250022
city: Saint-Mandé
country: France
facility: Investigational Site Number 250033
city: Sete
country: France
facility: Investigational Site Number 250055
city: Strasbourg Cedex 2
country: France
facility: Investigational Site Number 250031
city: Strasbourg
country: France
facility: Investigational Site Number 250056
city: Strasbourg
country: France
facility: Investigational Site Number 250001
city: Tarbes
country: France
facility: Investigational Site Number 250043
city: Toulouse Cedex 3
country: France
facility: Investigational Site Number 250002
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Investigational Site Number 250029
city: Venissieux
country: France
facility: Investigational Site Number 250009
city: VICHY Cedex
country: France
facility: Investigational Site Number 250007
city: Vichy
country: France
facility: Investigational Site Number 250006
city: Villeneuve sur Lot
country: France
facility: Investigational Site Number 250059
city: Bornheim
country: Germany
facility: Investigational Site Number 276013
city: Dresden
country: Germany
facility: Investigational Site Number 276002
city: Dresden
country: Germany
facility: Investigational Site Number 276001
city: Hamburg
country: Germany
facility: Investigational Site Number 276016
city: Hohenmölsen
country: Germany
facility: Investigational Site Number 276014
city: Münster
country: Germany
facility: Investigational Site Number 276017
city: Neumünster
country: Germany
facility: Investigational Site Number 276012
city: Neuwied
country: Germany
facility: Investigational Site Number 276009
city: Oldenburg
country: Germany
facility: Investigational Site Number 276008
city: Pirna
country: Germany
facility: Investigational Site Number 276006
city: Rehlingen-Siersburg
country: Germany
facility: Investigational Site Number 276010
city: Riesa
country: Germany
facility: Investigational Site Number 276005
city: Schweinfurt
country: Germany
facility: Investigational Site Number 276011
city: Sulzbach-Rosenberg
country: Germany
facility: Investigational Site Number 276007
city: Dublin 4
country: Ireland
facility: Investigational Site Number 372003
city: Dublin 7
country: Ireland
facility: Investigational Site Number 327002
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Investigational Site Number 642002
city: Bucuresti
country: Romania
facility: Investigational Site Number 642007
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642004
city: Galati
country: Romania
facility: Investigational Site Number 642005
city: Iasi
country: Romania
facility: Investigational Site Number 642009
city: Oradea
country: Romania
facility: Investigational Site Number 642006
city: Targoviste
country: Romania
facility: Investigational Site Number 642008
city: Almansa
country: Spain
facility: Investigational Site Number 724013
city: Badalona
country: Spain
facility: Investigational Site Number 724024
city: Barakaldo
country: Spain
facility: Investigational Site Number 724016
city: Barcelona
country: Spain
facility: Investigational Site Number 724005
city: Barcelona
country: Spain
facility: Investigational Site Number 724019
city: Barcelona
country: Spain
facility: Investigational Site Number 724017
city: Burgos
country: Spain
facility: Investigational Site Number 724008
city: Donostia
country: Spain
facility: Investigational Site Number 724018
city: Ferrol
country: Spain
facility: Investigational Site Number 724026
city: Gerona
country: Spain
facility: Investigational Site Number 724021
city: Huelva
country: Spain
facility: Investigational Site Number 724027
city: La Coruña
country: Spain
facility: Investigational Site Number 724014
city: LLeida
country: Spain
facility: Investigational Site Number 724001
city: Madrid
country: Spain
facility: Investigational Site Number 724025
city: Madrid
country: Spain
facility: Investigational Site Number 724028
city: Majadahonda
country: Spain
facility: Investigational Site Number 724006
city: Málaga
country: Spain
facility: Investigational Site Number 724030
city: Málaga
country: Spain
facility: Investigational Site Number 724020
city: Sabadell
country: Spain
facility: Investigational Site Number 724012
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number 724009
city: Sevilla
country: Spain
facility: Investigational Site Number 724010
city: Sevilla
country: Spain
facility: Investigational Site Number 724011
city: Valencia
country: Spain
facility: Investigational Site Number 724002
city: Valencia
country: Spain
facility: Investigational Site Number 724022
city: Vitoria
country: Spain
facility: Investigational Site Number 724007
city: Atherstone
country: United Kingdom
facility: Investigational Site Number 826033
city: Ayr
country: United Kingdom
facility: Investigational Site Number 826016
city: Bradford on Avon
country: United Kingdom
facility: Investigational Site Number 826008
city: Chertsey
country: United Kingdom
facility: Investigational Site Number 826004
city: Chesterfield
country: United Kingdom
facility: Investigational Site Number 826011
city: Chippenham
country: United Kingdom
facility: Investigational Site Number 826028
city: Cornwall
country: United Kingdom
facility: Investigational Site Number 826038
city: Cornwall
country: United Kingdom
facility: Investigational Site Number 826027
city: Coventry
country: United Kingdom
facility: Investigational Site Number 826031
city: Craigavon
country: United Kingdom
facility: Investigational Site Number 826003
city: Dudley
country: United Kingdom
facility: Investigational Site Number 826035
city: Larbert
country: United Kingdom
facility: Investigational Site Number 826015
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: 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
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.