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 (Reach-Control)

April 21, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Curitiba, Brazil, 80810-140
        • Investigational Site Number 076-001
      • Fortaleza, Brazil, 60115-282
        • Investigational Site Number 076005
      • Fortaleza, Brazil
        • Investigational Site Number 076004
      • Rio de Janeiro, Brazil, 202110340
        • Investigational Site Number 076009
      • Sao Paulo, Brazil, 01244-030
        • Investigational Site Number 076008
      • São José dos Campos, Brazil, 12243-280
        • Investigational Site Number 076011
      • São Paulo, Brazil, 04024-002
        • Investigational Site Number 076003
      • São paulo, Brazil, 01223-001
        • Investigational Site Number 076007
      • Taguatinga, Brazil, 72155000
        • Investigational Site Number 076010
  • France
      • Alencon Cedex, France, 61014
        • Investigational Site Number 250060
      • Amiens Cedex 1, France, 80054
        • Investigational Site Number 250023
      • BETHUNE Cedex, France, 62408
        • Investigational Site Number 250050
      • BOIS GUILLAUME Cedex, France, 76233
        • Investigational Site Number 250008
      • Bar le Duc, France
        • Investigational Site Number 250057
      • Bordeaux, France, 33000
        • Investigational Site Number 250024
      • Brest, France, 29000
        • Investigational Site Number 250028
      • CAHORS Cedex 9, France, 46005
        • Investigational Site Number 250003
      • CHALONS EN CHAMPAGNE Cedex, France, 51005
        • Investigational Site Number 250064
      • Caen, France, 14000
        • Investigational Site Number 250014
      • Cholet, France, 49300
        • Investigational Site Number 250026
      • Corbeil Essonnes, France, 91100
        • Investigational Site Number 250025
      • Eaubonne, France
        • Investigational Site Number 250011
      • La Roche Sur Yon, France, 85025
        • Investigational Site Number 250013
      • La Rochelle Cedex 1, France, 17019
        • Investigational Site Number 250058
      • La Seyne sur Mer, France
        • Investigational Site Number 250027
      • Lamagistere, France, 82360
        • Investigational Site Number 250034
      • Le Puy En Velay Cedex, France, 43012
        • Investigational Site Number 250017
      • Marseille, France, 13008
        • Investigational Site Number 250012
      • Maubeuge, France, 59600
        • Investigational Site Number 250054
      • Montpellier, France, 34059
        • Investigational Site Number 250045
      • Montpellier, France, 34295
        • Investigational Site Number 250020
      • Montpellier, France
        • Investigational Site Number 250016
      • Mulhouse, France
        • Investigational Site Number 250035
      • NARBONNE Cedex, France, 11018
        • Investigational Site Number 250004
      • Nevers, France, 58000
        • Investigational Site Number 250046
      • Nimes, France, 30029
        • Investigational Site Number 250041
      • Orleans, France, 45100
        • Investigational Site Number 250044
      • POITIERS Cedex, France, 86021
        • Investigational Site Number 250052
      • PRINGY Cedex, France, 74374
        • Investigational Site Number 250051
      • Paris, France, 75012
        • Investigational Site Number 250063
      • Paris, France, 75014
        • Investigational Site Number 250053
      • Paris, France, 75018
        • Investigational Site Number 250005
      • Paris, France, 75020
        • Investigational Site Number 250032
      • Pierre-Bénite, France, 69310
        • Investigational Site Number 250021
      • Pierre-Bénite, France, 69310
        • Investigational Site Number 250030
      • Reims Cedex, France, 51092
        • Investigational Site Number 250039
      • Roubaix, France, 59100
        • Investigational Site Number 250022
      • Saint-Mandé, France, 94160
        • Investigational Site Number 250033
      • Sete, France, 34200
        • Investigational Site Number 250055
      • Strasbourg, France, 67000
        • Investigational Site Number 250056
      • Strasbourg, France, 67091
        • Investigational Site Number 250001
      • Strasbourg Cedex 2, France, 67098
        • Investigational Site Number 250031
      • Tarbes, France, 65013
        • Investigational Site Number 250043
      • Toulouse Cedex 3, France, 31076
        • Investigational Site Number 250002
      • VICHY Cedex, France, 03201
        • Investigational Site Number 250007
      • Vandoeuvre Les Nancy Cedex, France, 54511
        • Investigational Site Number 250029
      • Venissieux, France, 69200
        • Investigational Site Number 250009
      • Vichy, France, 03200
        • Investigational Site Number 250006
      • Villeneuve sur Lot, France, 47300
        • Investigational Site Number 250059
  • Germany
      • Bornheim, Germany, 53332
        • Investigational Site Number 276013
      • Dresden, Germany, 01307
        • Investigational Site Number 276001
      • Dresden, Germany, 01279
        • Investigational Site Number 276002
      • Hamburg, Germany, 22607
        • Investigational Site Number 276016
      • Hohenmölsen, Germany, 06679
        • Investigational Site Number 276014
      • Münster, Germany, 48153
        • Investigational Site Number 276017
      • Neumünster, Germany, 24534
        • Investigational Site Number 276012
      • Neuwied, Germany, 56564
        • Investigational Site Number 276009
      • Oldenburg, Germany, 26133
        • Investigational Site Number 276008
      • Pirna, Germany, 01796
        • Investigational Site Number 276006
      • Rehlingen-Siersburg, Germany, 66780
        • Investigational Site Number 276010
      • Riesa, Germany, 01587
        • Investigational Site Number 276005
      • Schweinfurt, Germany, 97421
        • Investigational Site Number 276011
      • Sulzbach-Rosenberg, Germany, 92237
        • Investigational Site Number 276007
  • Ireland
      • Dublin 4, Ireland
        • Investigational Site Number 372003
      • Dublin 7, Ireland
        • Investigational Site Number 327002
  • Romania
      • Bucuresti, Romania, 010825
        • Investigational Site Number 642001
      • Bucuresti, Romania, 022441
        • Investigational Site Number 642002
      • Bucuresti, Romania
        • Investigational Site Number 642007
      • Cluj-Napoca, Romania, 400006
        • Investigational Site Number 642004
      • Galati, Romania, 800291
        • Investigational Site Number 642005
      • Iasi, Romania
        • Investigational Site Number 642009
      • Oradea, Romania, 410169
        • Investigational Site Number 642006
      • Targoviste, Romania, 130083
        • Investigational Site Number 642008
  • Spain
      • Almansa, Spain, 02640
        • Investigational Site Number 724013
      • Badalona, Spain, 08915
        • Investigational Site Number 724024
      • Barakaldo, Spain, 48903
        • Investigational Site Number 724016
      • Barcelona, Spain, 08025
        • Investigational Site Number 724005
      • Barcelona, Spain, 08035
        • Investigational Site Number 724019
      • Barcelona, Spain
        • Investigational Site Number 724017
      • Burgos, Spain
        • Investigational Site Number 724008
      • Donostia, Spain, 20014
        • Investigational Site Number 724018
      • Ferrol, Spain, 15405
        • Investigational Site Number 724026
      • Gerona, Spain, 17007
        • Investigational Site Number 724021
      • Huelva, Spain, 21005
        • Investigational Site Number 724027
      • LLeida, Spain
        • Investigational Site Number 724001
      • La Coruña, Spain, 15006
        • Investigational Site Number 724014
      • Madrid, Spain, 28040
        • Investigational Site Number 724025
      • Madrid, Spain, 28041
        • Investigational Site Number 724028
      • Majadahonda, Spain, 28222
        • Investigational Site Number 724006
      • Málaga, Spain, 29004
        • Investigational Site Number 724030
      • Málaga, Spain, 29010
        • Investigational Site Number 724020
      • Sabadell, Spain, 08208
        • Investigational Site Number 724012
      • Santiago de Compostela, Spain, 15706
        • Investigational Site Number 724009
      • Sevilla, Spain, 41010
        • Investigational Site Number 724010
      • Sevilla, Spain, 41013
        • Investigational Site Number 724011
      • Valencia, Spain, 46009
        • Investigational Site Number 724002
      • Valencia, Spain, 46014
        • Investigational Site Number 724022
      • Vitoria, Spain, 1009
        • Investigational Site Number 724007
  • United Kingdom
      • Atherstone, United Kingdom, CV91EU
        • Investigational Site Number 826033
      • Ayr, United Kingdom, KA66DX
        • Investigational Site Number 826016
      • Bradford on Avon, United Kingdom, BA151DQ
        • Investigational Site Number 826008
      • Chertsey, United Kingdom, KT160PZ
        • Investigational Site Number 826004
      • Chesterfield, United Kingdom, S404TF
        • Investigational Site Number 826011
      • Chippenham, United Kingdom, SN152SB
        • Investigational Site Number 826028
      • Cornwall, United Kingdom, PL143XA
        • Investigational Site Number 826038
      • Cornwall, United Kingdom, PL231DT
        • Investigational Site Number 826027
      • Coventry, United Kingdom, CV22DX
        • Investigational Site Number 826031
      • Craigavon, United Kingdom, BT635QQ
        • Investigational Site Number 826003
      • Dudley, United Kingdom, DY1 2HQ
        • Investigational Site Number 826035
      • Larbert, United Kingdom, FK54WR
        • Investigational Site Number 826015
      • Liverpool, United Kingdom, L97AL
        • Investigational Site Number 826002
      • Manchester, United Kingdom, M239LT
        • Investigational Site Number 826018
      • Manchester, United Kingdom, M85RB
        • Investigational Site Number 826019
      • Nuneaton, United Kingdom, CV107DJ
        • Investigational Site Number 826009
      • Plymouth, United Kingdom, PL53JB
        • Investigational Site Number 826021
      • Portsmouth, United Kingdom, PO63LY
        • Investigational Site Number 826006
      • Southampton, United Kingdom, SO303JB
        • Investigational Site Number 826020
      • Taunton, United Kingdom, TA15DA
        • Investigational Site Number 826013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toujeo
Toujeo will be administered once daily in addition to noninsulin antidiabetic agents
Drug: insulin glargine (U300)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • HOE901; Toujeo
Active Comparator: "Standard of care" commercially available basal 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
Drug: NPH insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • Humulin NPH
Drug: insulin glargine (U100)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • HOE901; Lantus
Drug: insulin detemir

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • Levemir
Drug: insulin degludec

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • Tresiba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c (percentage %)
Time Frame: Baseline to 6 Months
Baseline to 6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 5, 2015

Primary Completion (Actual)

October 16, 2017

Study Completion (Actual)

October 16, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS13931
  • 2015-001831-18 (EudraCT Number)
  • U1111-1170-8104 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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