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Diabetes Mellitus, Type 2Phase 4Transition IINCT02967237

Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

A Phase 4 study testing insulin glargine (U300) in people with Diabetes Mellitus, Type 2, run by Sanofi at 85 sites in France.

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: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. 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)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
85 sitesFrance
Study dates
4 Jan 2016to 24 Jul 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

  • Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist
  • HbA1c > 7.5%

Who cannot join

  • Patients with high dose of insulin (>1.2 U/kg)
  • Use of prandial insulin
  • Change of dose of antidiabetic drugs within the last 8 weeks
  • Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks
  • 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

85 sites in 1 country.

85 sites in 1 country

France85 sites

  • Investigational Site Number 250017

    Alençon, 61014

  • Investigational Site Number 250073

    Alès, 30100

  • Investigational Site Number 250047

    Amiens, 80054

  • Investigational Site Number 250028

    Amilly

  • Investigational Site Number 250062

    Bagnols-sur-Cèze

  • Investigational Site Number 250093

    Bar-le-Duc

  • Investigational Site Number 250020

    Besançon, 25030

  • Investigational Site Number 250081

    Béthune, 62408

  • Investigational Site Number 250034

    Bondy, 93143

  • Investigational Site Number 250022

    Brest, 29000

  • Investigational Site Number 250070

    Brest, 29610

  • Investigational Site Number 250060

    Cahors, 46005

  • Investigational Site Number 250096

    Cannes, 06401

  • Investigational Site Number 250037

    Châlons-en-Champagne, 51005

  • Investigational Site Number 250072

    Chambéry, 73000

  • Investigational Site Number 250018

    Cholet, 49300

  • Investigational Site Number 250068

    Clermont-Ferrand, 63000

  • Investigational Site Number 250098

    Cognac, 16112

  • Investigational Site Number 250048

    Colmar, 68024

  • Investigational Site Number 250088

    Contamines Sur Arve, 74130

  • Investigational Site Number 250054

    Coudray, 28630

  • Investigational Site Number 250063

    Dijon, 21000

  • Investigational Site Number 250013

    Eaubonne

  • Investigational Site Number 250095

    Étampes

  • Investigational Site Number 250104

    Grenoble, 38043

  • Investigational Site Number 250004

    La Roche-sur-Yon, 85025

  • Investigational Site Number 250002

    La Rochelle, 17019

  • Investigational Site Number 250019

    La Seyne-sur-Mer

  • Investigational Site Number 250030

    Lamagistère, 82360

  • Investigational Site Number 250103

    Le Chesnay, 78157

  • Investigational Site Number 250053

    Le Creusot, 71200

  • Investigational Site Number 250044

    Le Mans, 72037

  • Investigational Site Number 250056

    Lens

  • Investigational Site Number 250051

    Lourdes, 65000

  • Investigational Site Number 250071

    Mantes-la-Jolie

  • Investigational Site Number 250092

    Marseille, 13006

  • Investigational Site Number 250064

    Marseille, 13008

  • Investigational Site Number 250089

    Maubeuge, 59600

  • Investigational Site Number 250083

    Mérignac, 33700

  • Investigational Site Number 250035

    Montpellier, 34000

  • Investigational Site Number 250061

    Montpellier, 34059

  • Investigational Site Number 250010

    Montpellier, 34295

  • Investigational Site Number 250008

    Montpellier

  • Investigational Site Number 250032

    Mulhouse

  • Investigational Site Number 250043

    Nancy

  • Investigational Site Number 250005

    Narbonne, 11018

  • Investigational Site Number 250069

    Nevers, 58000

  • Investigational Site Number 250052

    Nîmes, 30029

  • Investigational Site Number 250059

    Noisy-le-Grand

  • Investigational Site Number 250058

    Orléans, 45100

  • Investigational Site Number 250031

    Paris, 75008

  • Investigational Site Number 250105

    Paris, 75012

  • Investigational Site Number 250086

    Paris, 75014

  • Investigational Site Number 250026

    Paris, 75020

  • Investigational Site Number 250084

    Périgueux, 24019

  • Investigational Site Number 250101

    Pessac, 33604

  • Investigational Site Number 250107

    Pointe à Pitre, 97159

  • Investigational Site Number 250067

    Pontoise, 95300

  • Investigational Site Number 250078

    Pringy, 74374

  • Investigational Site Number 250042

    Reims, 51092

  • Investigational Site Number 250012

    Roubaix, 59100

  • Investigational Site Number 250055

    Roubaix, 59100

  • Investigational Site Number 250102

    Saint-Brieuc

  • Investigational Site Number 250065

    Saint-Denis, 93200

  • Investigational Site Number 250029

    Saint-Mandé, 94160

  • Investigational Site Number 250108

    Saint-Pierre, 97448

  • Investigational Site Number 250087

    Seclin, 59113

  • Investigational Site Number 250090

    Sète, 34200

  • Investigational Site Number 250006

    Strasbourg, 67000

  • Investigational Site Number 250024

    Strasbourg, 67098

  • Investigational Site Number 250033

    Suresnes, 92150

  • Investigational Site Number 250057

    Tarbes, 65013

  • Investigational Site Number 250001

    Toulouse, 31000

  • Investigational Site Number 250076

    Toulouse, 31027

  • Investigational Site Number 250082

    Toulouse, 31076

  • Investigational Site Number 250050

    Toulouse, 31100

  • Investigational Site Number 250027

    Tours, 37000

  • Investigational Site Number 250075

    Tours, 37000

  • Investigational Site Number 250041

    Valenciennes, 59322

  • Investigational Site Number 250021

    Vandœuvre-lès-Nancy, 54511

  • Investigational Site Number 250023

    Vénissieux, 69200

  • Investigational Site Number 250039

    Vichy, 03200

  • Investigational Site Number 250046

    Vichy, 03201

  • Investigational Site Number 250100

    Villeneuve-sur-Lot, 47300

  • Investigational Site Number 250007

    Warloy-Baillon, 80300

Other trials in France

About this study

Official title: An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

  • Evolution of fasting plasma glucose
  • Evolution of insulin dose and body weight
  • Hypoglycemia incidence
  • Safety
  • Patients satisfaction when they change their insulin for HOE901-U300
Read the detailed description

The total study duration per patient is approximately 28 weeks.

Being tested
insulin glargine (U300)
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

Study groups in NCT02967237
Study groupRoleWhat they receive
Insulin glargine (U300)ExperimentalType 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen
Receives: Drug: insulin glargine (U300)

What is being measured

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

  1. Mean change from baseline in HbA1c

    Measured: Baseline, Week 24

Secondary outcomes (8)

  1. Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)

    Measured: At Weeks 12 and 24

  2. Percentage of patients with HbA1c <7%, <7.5%, and <8%

    Measured: At Week 24

  3. Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)

    Measured: Baseline to Week 12 and Week 24

  4. Mean change from baseline in fasting plasma glucose

    Measured: Baseline to Week 12 and Week 24

  5. Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Measured: Baseline to Week 24

  6. Change in Diabetes Treatment Satisfaction Questionnaire score

    Measured: Week 24

  7. Number of hypoglycemic events

    Measured: From inclusion up to Week 24

  8. Number of adverse events

    Measured: From inclusion up to Week 24

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 start4 Jan 2016
  3. Primary completion24 Jul 2017
  4. Study completion24 Jul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967237
Sponsor's protocol ID
GLARGL07667
Other IDs
2015-002416-33, U1111-1176-6203, 2015
Acronym
Transition II
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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin glargine (U300) in people with Diabetes Mellitus, Type 2, run by Sanofi at 85 sites in France.

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 2 inclusion and 5 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 85 sites in France. 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?

Mean change from baseline in HbA1c (time frame: Baseline, Week 24). 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 NCT02967237.

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.

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