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

Diabetes Mellitus, Type 2 Clinical Trial

— Reach-Control  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967224
• Other study ID #: LPS13931
• Secondary ID: 2015-001831-18U1
• Status: Completed
• Phase: Phase 4
• Start date: November 5, 2015
• Est. completion date: October 16, 2017

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin glargine (U100)
Pharmaceutical form: solution Route of administration: subcutaneous
• NPH insulin
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin detemir
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin degludec
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Brazil	Investigational Site Number 076-001	Curitiba
Brazil	Investigational Site Number 076004	Fortaleza
Brazil	Investigational Site Number 076005	Fortaleza
Brazil	Investigational Site Number 076009	Rio de Janeiro
Brazil	Investigational Site Number 076011	São José dos Campos
Brazil	Investigational Site Number 076008	Sao Paulo
Brazil	Investigational Site Number 076003	São Paulo
Brazil	Investigational Site Number 076007	São paulo
Brazil	Investigational Site Number 076010	Taguatinga
France	Investigational Site Number 250060	Alencon Cedex
France	Investigational Site Number 250023	Amiens Cedex 1
France	Investigational Site Number 250057	Bar le Duc
France	Investigational Site Number 250050	BETHUNE Cedex
France	Investigational Site Number 250008	BOIS GUILLAUME Cedex
France	Investigational Site Number 250024	Bordeaux
France	Investigational Site Number 250028	Brest
France	Investigational Site Number 250014	Caen
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 250025	Corbeil Essonnes
France	Investigational Site Number 250011	Eaubonne
France	Investigational Site Number 250013	La Roche Sur Yon
France	Investigational Site Number 250058	La Rochelle Cedex 1
France	Investigational Site Number 250027	La Seyne sur Mer
France	Investigational Site Number 250034	Lamagistere
France	Investigational Site Number 250017	Le Puy En Velay Cedex
France	Investigational Site Number 250012	Marseille
France	Investigational Site Number 250054	Maubeuge
France	Investigational Site Number 250016	Montpellier
France	Investigational Site Number 250020	Montpellier
France	Investigational Site Number 250045	Montpellier
France	Investigational Site Number 250035	Mulhouse
France	Investigational Site Number 250004	NARBONNE Cedex
France	Investigational Site Number 250046	Nevers
France	Investigational Site Number 250041	Nimes
France	Investigational Site Number 250044	Orleans
France	Investigational Site Number 250005	Paris
France	Investigational Site Number 250032	Paris
France	Investigational Site Number 250053	Paris
France	Investigational Site Number 250063	Paris
France	Investigational Site Number 250021	Pierre-Bénite
France	Investigational Site Number 250030	Pierre-Bénite
France	Investigational Site Number 250052	POITIERS Cedex
France	Investigational Site Number 250051	PRINGY Cedex
France	Investigational Site Number 250039	Reims Cedex
France	Investigational Site Number 250022	Roubaix
France	Investigational Site Number 250033	Saint-Mandé
France	Investigational Site Number 250055	Sete
France	Investigational Site Number 250001	Strasbourg
France	Investigational Site Number 250056	Strasbourg
France	Investigational Site Number 250031	Strasbourg Cedex 2
France	Investigational Site Number 250043	Tarbes
France	Investigational Site Number 250002	Toulouse Cedex 3
France	Investigational Site Number 250029	Vandoeuvre Les Nancy Cedex
France	Investigational Site Number 250009	Venissieux
France	Investigational Site Number 250006	Vichy
France	Investigational Site Number 250007	VICHY Cedex
France	Investigational Site Number 250059	Villeneuve sur Lot
Germany	Investigational Site Number 276013	Bornheim
Germany	Investigational Site Number 276001	Dresden
Germany	Investigational Site Number 276002	Dresden
Germany	Investigational Site Number 276016	Hamburg
Germany	Investigational Site Number 276014	Hohenmölsen
Germany	Investigational Site Number 276017	Münster
Germany	Investigational Site Number 276012	Neumünster
Germany	Investigational Site Number 276009	Neuwied
Germany	Investigational Site Number 276008	Oldenburg
Germany	Investigational Site Number 276006	Pirna
Germany	Investigational Site Number 276010	Rehlingen-Siersburg
Germany	Investigational Site Number 276005	Riesa
Germany	Investigational Site Number 276011	Schweinfurt
Germany	Investigational Site Number 276007	Sulzbach-Rosenberg
Ireland	Investigational Site Number 372003	Dublin 4
Ireland	Investigational Site Number 327002	Dublin 7
Romania	Investigational Site Number 642001	Bucuresti
Romania	Investigational Site Number 642002	Bucuresti
Romania	Investigational Site Number 642007	Bucuresti
Romania	Investigational Site Number 642004	Cluj-Napoca
Romania	Investigational Site Number 642005	Galati
Romania	Investigational Site Number 642009	Iasi
Romania	Investigational Site Number 642006	Oradea
Romania	Investigational Site Number 642008	Targoviste
Spain	Investigational Site Number 724013	Almansa
Spain	Investigational Site Number 724024	Badalona
Spain	Investigational Site Number 724016	Barakaldo
Spain	Investigational Site Number 724005	Barcelona
Spain	Investigational Site Number 724017	Barcelona
Spain	Investigational Site Number 724019	Barcelona
Spain	Investigational Site Number 724008	Burgos
Spain	Investigational Site Number 724018	Donostia
Spain	Investigational Site Number 724026	Ferrol
Spain	Investigational Site Number 724021	Gerona
Spain	Investigational Site Number 724027	Huelva
Spain	Investigational Site Number 724014	La Coruña
Spain	Investigational Site Number 724001	LLeida
Spain	Investigational Site Number 724025	Madrid
Spain	Investigational Site Number 724028	Madrid
Spain	Investigational Site Number 724006	Majadahonda
Spain	Investigational Site Number 724020	Málaga
Spain	Investigational Site Number 724030	Málaga
Spain	Investigational Site Number 724012	Sabadell
Spain	Investigational Site Number 724009	Santiago de Compostela
Spain	Investigational Site Number 724010	Sevilla
Spain	Investigational Site Number 724011	Sevilla
Spain	Investigational Site Number 724002	Valencia
Spain	Investigational Site Number 724022	Valencia
Spain	Investigational Site Number 724007	Vitoria
United Kingdom	Investigational Site Number 826033	Atherstone
United Kingdom	Investigational Site Number 826016	Ayr
United Kingdom	Investigational Site Number 826008	Bradford on Avon
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 826038	Cornwall
United Kingdom	Investigational Site Number 826031	Coventry
United Kingdom	Investigational Site Number 826003	Craigavon
United Kingdom	Investigational Site Number 826035	Dudley
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 826019	Manchester
United Kingdom	Investigational Site Number 826009	Nuneaton
United Kingdom	Investigational Site Number 826021	Plymouth
United Kingdom	Investigational Site Number 826006	Portsmouth
United Kingdom	Investigational Site Number 826020	Southampton
United Kingdom	Investigational Site Number 826013	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  France,  Germany,  Ireland,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (percentage %)		Baseline to 6 Months
Secondary	Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)		At Month 6 and Month 12
Secondary	Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not		At Month 6 and Month 12
Secondary	Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)		At Month 6 and Month 12
Secondary	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
Secondary	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
Secondary	Change in HbA1c (percentage %)		Baseline to Month 12
Secondary	Percentage of patients whose HbA1c decreased at least 1%		At Month 6 and Month 12
Secondary	Percentage of patients whose HbA1c decreased at least 1%		At Month 6 and maintained at Month 12
Secondary	Percentage of patients requiring intensification		At Month 6 and Month 12
Secondary	Time to intensification		At Month 6 and Month 12
Secondary	Change in fasting plasma glucose		Baseline to Month 6 and Month 12