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Diabetes Mellitus, Type 2Phase 4Reach-ControlNCT02967224

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

A Phase 4 study testing insulin glargine (U300), insulin glargine (U100) and NPH insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 128 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
insulin glargine (U300), insulin glargine (U100) and NPH insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
705 participants
Where
128 sitesin 7 countries
Study dates
5 Nov 2015to 16 Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

128 sites in 7 countries.

128 sites in 7 countries

France50 sites

  • Investigational Site Number 250060

    Alençon, 61014

  • Investigational Site Number 250023

    Amiens, 80054

  • Investigational Site Number 250057

    Bar-le-Duc

  • Investigational Site Number 250050

    Béthune, 62408

  • Investigational Site Number 250008

    Bois-Guillaume, 76233

  • Investigational Site Number 250024

    Bordeaux, 33000

  • Investigational Site Number 250028

    Brest, 29000

  • Investigational Site Number 250014

    Caen, 14000

  • Investigational Site Number 250003

    Cahors, 46005

  • Investigational Site Number 250064

    Châlons-en-Champagne, 51005

  • Investigational Site Number 250026

    Cholet, 49300

  • Investigational Site Number 250025

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250011

    Eaubonne

  • Investigational Site Number 250013

    La Roche-sur-Yon, 85025

  • Investigational Site Number 250058

    La Rochelle, 17019

  • Investigational Site Number 250027

    La Seyne-sur-Mer

  • Investigational Site Number 250034

    Lamagistère, 82360

  • Investigational Site Number 250017

    Le Puy-en-Velay, 43012

  • Investigational Site Number 250012

    Marseille, 13008

  • Investigational Site Number 250054

    Maubeuge, 59600

  • Investigational Site Number 250045

    Montpellier, 34059

  • Investigational Site Number 250020

    Montpellier, 34295

  • Investigational Site Number 250016

    Montpellier

  • Investigational Site Number 250035

    Mulhouse

  • Investigational Site Number 250004

    Narbonne, 11018

  • Investigational Site Number 250046

    Nevers, 58000

  • Investigational Site Number 250041

    Nîmes, 30029

  • Investigational Site Number 250044

    Orléans, 45100

  • Investigational Site Number 250063

    Paris, 75012

  • Investigational Site Number 250053

    Paris, 75014

  • Investigational Site Number 250005

    Paris, 75018

  • Investigational Site Number 250032

    Paris, 75020

  • Investigational Site Number 250021

    Pierre-Bénite, 69310

  • Investigational Site Number 250030

    Pierre-Bénite, 69310

  • Investigational Site Number 250052

    Poitiers, 86021

  • Investigational Site Number 250051

    Pringy, 74374

  • Investigational Site Number 250039

    Reims, 51092

  • Investigational Site Number 250022

    Roubaix, 59100

  • Investigational Site Number 250033

    Saint-Mandé, 94160

  • Investigational Site Number 250055

    Sète, 34200

  • Investigational Site Number 250056

    Strasbourg, 67000

  • Investigational Site Number 250001

    Strasbourg, 67091

  • Investigational Site Number 250031

    Strasbourg, 67098

  • Investigational Site Number 250043

    Tarbes, 65013

  • Investigational Site Number 250002

    Toulouse, 31076

  • Investigational Site Number 250029

    Vandœuvre-lès-Nancy, 54511

  • Investigational Site Number 250009

    Vénissieux, 69200

  • Investigational Site Number 250006

    Vichy, 03200

  • Investigational Site Number 250007

    Vichy, 03201

  • Investigational Site Number 250059

    Villeneuve-sur-Lot, 47300

Other trials in France

Spain25 sites

  • Investigational Site Number 724014

    A Coruña, 15006

  • Investigational Site Number 724013

    Almansa, 02640

  • Investigational Site Number 724024

    Badalona, 08915

  • Investigational Site Number 724016

    Barakaldo, 48903

  • Investigational Site Number 724005

    Barcelona, 08025

  • Investigational Site Number 724019

    Barcelona, 08035

  • Investigational Site Number 724017

    Barcelona

  • Investigational Site Number 724008

    Burgos

  • Investigational Site Number 724018

    Donostia / San Sebastian, 20014

  • Investigational Site Number 724026

    Ferrol, 15405

  • Investigational Site Number 724021

    Girona, 17007

  • Investigational Site Number 724027

    Huelva, 21005

  • Investigational Site Number 724001

    Lleida

  • Investigational Site Number 724025

    Madrid, 28040

  • Investigational Site Number 724028

    Madrid, 28041

  • Investigational Site Number 724006

    Majadahonda, 28222

  • Investigational Site Number 724030

    Málaga, 29004

  • Investigational Site Number 724020

    Málaga, 29010

  • Investigational Site Number 724012

    Sabadell, 08208

  • Investigational Site Number 724009

    Santiago de Compostela, 15706

  • Investigational Site Number 724010

    Seville, 41010

  • Investigational Site Number 724011

    Seville, 41013

  • Investigational Site Number 724002

    Valencia, 46009

  • Investigational Site Number 724022

    Valencia, 46014

  • Investigational Site Number 724007

    Vitoria-Gasteiz, 1009

Other trials in Spain

United Kingdom20 sites

  • Investigational Site Number 826033

    Atherstone, CV91EU

  • Investigational Site Number 826016

    Ayr, KA66DX

  • Investigational Site Number 826008

    Bradford on Avon, BA151DQ

  • Investigational Site Number 826004

    Chertsey, KT160PZ

  • Investigational Site Number 826011

    Chesterfield, S404TF

  • Investigational Site Number 826028

    Chippenham, SN152SB

  • Investigational Site Number 826038

    Cornwall, PL143XA

  • Investigational Site Number 826027

    Cornwall, PL231DT

  • Investigational Site Number 826031

    Coventry, CV22DX

  • Investigational Site Number 826003

    Craigavon, BT635QQ

  • Investigational Site Number 826035

    Dudley, DY1 2HQ

  • Investigational Site Number 826015

    Larbert, FK54WR

  • Investigational Site Number 826002

    Liverpool, L97AL

  • Investigational Site Number 826018

    Manchester, M239LT

  • Investigational Site Number 826019

    Manchester, M85RB

  • Investigational Site Number 826009

    Nuneaton, CV107DJ

  • Investigational Site Number 826021

    Plymouth, PL53JB

  • Investigational Site Number 826006

    Portsmouth, PO63LY

  • Investigational Site Number 826020

    Southampton, SO303JB

  • Investigational Site Number 826013

    Taunton, TA15DA

Other trials in United Kingdom

Germany14 sites

  • Investigational Site Number 276013

    Bornheim, 53332

  • Investigational Site Number 276002

    Dresden, 01279

  • Investigational Site Number 276001

    Dresden, 01307

  • Investigational Site Number 276016

    Hamburg, 22607

  • Investigational Site Number 276014

    Hohenmölsen, 06679

  • Investigational Site Number 276017

    Münster, 48153

  • Investigational Site Number 276012

    Neumünster, 24534

  • Investigational Site Number 276009

    Neuwied, 56564

  • Investigational Site Number 276008

    Oldenburg, 26133

  • Investigational Site Number 276006

    Pirna, 01796

  • Investigational Site Number 276010

    Rehlingen-Siersburg, 66780

  • Investigational Site Number 276005

    Riesa, 01587

  • Investigational Site Number 276011

    Schweinfurt, 97421

  • Investigational Site Number 276007

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Brazil9 sites

  • Investigational Site Number 076-001

    Curitiba, 80810-140

  • Investigational Site Number 076005

    Fortaleza, 60115-282

  • Investigational Site Number 076004

    Fortaleza

  • Investigational Site Number 076009

    Rio de Janeiro, 202110340

  • Investigational Site Number 076011

    São José dos Campos, 12243-280

  • Investigational Site Number 076007

    São Paulo, 01223-001

  • Investigational Site Number 076008

    São Paulo, 01244-030

  • Investigational Site Number 076003

    São Paulo, 04024-002

  • Investigational Site Number 076010

    Taguatinga, 72155000

Other trials in Brazil

Romania8 sites

  • Investigational Site Number 642001

    Bucharest, 010825

  • Investigational Site Number 642002

    Bucharest, 022441

  • Investigational Site Number 642007

    Bucharest

  • Investigational Site Number 642004

    Cluj-Napoca, 400006

  • Investigational Site Number 642005

    Galati, 800291

  • Investigational Site Number 642009

    Iași

  • Investigational Site Number 642006

    Oradea, 410169

  • Investigational Site Number 642008

    Targoviste, 130083

Other trials in Romania

Ireland2 sites

  • Investigational Site Number 327002

    Dublin

  • Investigational Site Number 372003

    Dublin

Other trials in Ireland

About this study

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

Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Read more

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.
Read the 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.

Being tested
insulin glargine (U300), insulin glargine (U100), NPH insulin, insulin detemir, insulin degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin glargine (U300)Drug

    Also called HOE901; Toujeo

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • insulin glargine (U100)Drug

    Also called HOE901; Lantus

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • NPH insulinDrug

    Also called Humulin NPH

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • insulin detemirDrug

    Also called Levemir

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • insulin degludecDrug

    Also called Tresiba

    Pharmaceutical form: solution

    Route of administration: subcutaneous

Study groups in NCT02967224
Study groupRoleWhat they receive
ToujeoExperimentalToujeo will be administered once daily in addition to noninsulin antidiabetic agents
Receives: Drug: insulin glargine (U300)
"Standard of care" commercially available basal insulinActive comparatorLantus, 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
Receives: Drug: insulin glargine (U100); Drug: NPH insulin; Drug: insulin detemir; Drug: insulin degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (percentage %)

    Measured: Baseline to 6 Months

Secondary outcomes (11)

  1. Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)

    Measured: At Month 6 and Month 12

  2. Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not

    Measured: At Month 6 and Month 12

  3. Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)

    Measured: At Month 6 and Month 12

  4. 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

    Measured: At Month 6 and Month 12

  5. 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

    Measured: At Month 6 and Month 12

  6. Change in HbA1c (percentage %)

    Measured: Baseline to Month 12

  7. Percentage of patients whose HbA1c decreased at least 1%

    Measured: At Month 6 and Month 12

  8. Percentage of patients whose HbA1c decreased at least 1%

    Measured: At Month 6 and maintained at Month 12

  9. Percentage of patients requiring intensification

    Measured: At Month 6 and Month 12

  10. Time to intensification

    Measured: At Month 6 and Month 12

  11. Change in fasting plasma glucose

    Measured: Baseline to Month 6 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study start5 Nov 2015
  3. Primary completion16 Oct 2017
  4. Study completion16 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967224
Sponsor's protocol ID
LPS13931
Other IDs
2015-001831-18, U1111-1170-8104, 2015
Acronym
Reach-Control
Status last verified
Apr 2022
First submitted
16 Nov 2016
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 33166419

  • 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.

    PubMed 31865758

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin glargine (U300), insulin glargine (U100) and NPH insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 128 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in France, Spain, United Kingdom, Germany, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (percentage %) (time frame: Baseline to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02967224, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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