Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment (Transition II)

April 21, 2022 updated by: Sanofi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The total study duration per patient is approximately 28 weeks.

Study Type

Interventional

Enrollment (Actual)

136

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

  • France
      • Alencon Cedex, France, 61014
        • Investigational Site Number 250017
      • Ales, France, 30100
        • Investigational Site Number 250073
      • Amiens Cedex 1, France, 80054
        • Investigational Site Number 250047
      • Amilly, France
        • Investigational Site Number 250028
      • BETHUNE Cedex, France, 62408
        • Investigational Site Number 250081
      • Bagnols-sur-Cèze, France
        • Investigational Site Number 250062
      • Bar le Duc, France
        • Investigational Site Number 250093
      • Besancon, France, 25030
        • Investigational Site Number 250020
      • Bondy, France, 93143
        • Investigational Site Number 250034
      • Brest, France, 29000
        • Investigational Site Number 250022
      • Brest Cedex, France, 29610
        • Investigational Site Number 250070
      • CAHORS Cedex 9, France, 46005
        • Investigational Site Number 250060
      • CHALONS EN CHAMPAGNE Cedex, France, 51005
        • Investigational Site Number 250037
      • Cannes, France, 06401
        • Investigational Site Number 250096
      • Chambery, France, 73000
        • Investigational Site Number 250072
      • Cholet, France, 49300
        • Investigational Site Number 250018
      • Clermont Ferrand, France, 63000
        • Investigational Site Number 250068
      • Cognac, France, 16112
        • Investigational Site Number 250098
      • Colmar, France, 68024
        • Investigational Site Number 250048
      • Contamines Sur Arve, France, 74130
        • Investigational Site Number 250088
      • Coudray, France, 28630
        • Investigational Site Number 250054
      • Dijon, France, 21000
        • Investigational Site Number 250063
      • Eaubonne, France
        • Investigational Site Number 250013
      • Etampes, France
        • Investigational Site Number 250095
      • Grenoble, France, 38043
        • Investigational Site Number 250104
      • LE CHESNAY Cedex, France, 78157
        • Investigational Site Number 250103
      • La Roche Sur Yon, France, 85025
        • Investigational Site Number 250004
      • La Rochelle Cedex 1, France, 17019
        • Investigational Site Number 250002
      • La Seyne sur Mer, France
        • Investigational Site Number 250019
      • Lamagistere, France, 82360
        • Investigational Site Number 250030
      • Le Creusot, France, 71200
        • Investigational Site Number 250053
      • Le Mans Cedex 9, France, 72037
        • Investigational Site Number 250044
      • Lens, France
        • Investigational Site Number 250056
      • Lourdes, France, 65000
        • Investigational Site Number 250051
      • Mantes La Jolie, France
        • Investigational Site Number 250071
      • Marseille, France, 13006
        • Investigational Site Number 250092
      • Marseille, France, 13008
        • Investigational Site Number 250064
      • Maubeuge, France, 59600
        • Investigational Site Number 250089
      • Merignac, France, 33700
        • Investigational Site Number 250083
      • Montpellier, France, 34000
        • Investigational Site Number 250035
      • Montpellier, France, 34059
        • Investigational Site Number 250061
      • Montpellier, France, 34295
        • Investigational Site Number 250010
      • Montpellier, France
        • Investigational Site Number 250008
      • Mulhouse, France
        • Investigational Site Number 250032
      • NARBONNE Cedex, France, 11018
        • Investigational Site Number 250005
      • Nancy, France
        • Investigational Site Number 250043
      • Nevers, France, 58000
        • Investigational Site Number 250069
      • Nimes, France, 30029
        • Investigational Site Number 250052
      • Noisy Le Grand, France
        • Investigational Site Number 250059
      • Orleans, France, 45100
        • Investigational Site Number 250058
      • PERIGUEUX Cedex, France, 24019
        • Investigational Site Number 250084
      • PRINGY Cedex, France, 74374
        • Investigational Site Number 250078
      • Paris, France, 75008
        • Investigational Site Number 250031
      • Paris, France, 75012
        • Investigational Site Number 250105
      • Paris, France, 75014
        • Investigational Site Number 250086
      • Paris, France, 75020
        • Investigational Site Number 250026
      • Pessac Cedex, France, 33604
        • Investigational Site Number 250101
      • Pointe À Pitre, France, 97159
        • Investigational Site Number 250107
      • Pontoise, France, 95300
        • Investigational Site Number 250067
      • Reims Cedex, France, 51092
        • Investigational Site Number 250042
      • Roubaix, France, 59100
        • Investigational Site Number 250012
      • Roubaix, France, 59100
        • Investigational Site Number 250055
      • Saint Brieuc, France
        • Investigational Site Number 250102
      • Saint Pierre, France, 97448
        • Investigational Site Number 250108
      • Saint-Denis, France, 93200
        • Investigational Site Number 250065
      • Saint-Mandé, France, 94160
        • Investigational Site Number 250029
      • Seclin, France, 59113
        • Investigational Site Number 250087
      • Sete, France, 34200
        • Investigational Site Number 250090
      • Strasbourg, France, 67000
        • Investigational Site Number 250006
      • Strasbourg Cedex 2, France, 67098
        • Investigational Site Number 250024
      • Suresnes, France, 92150
        • Investigational Site Number 250033
      • Tarbes, France, 65013
        • Investigational Site Number 250057
      • Toulouse, France, 31000
        • Investigational Site Number 250001
      • Toulouse, France, 31027
        • Investigational Site Number 250076
      • Toulouse, France, 31100
        • Investigational Site Number 250050
      • Toulouse Cedex 3, France, 31076
        • Investigational Site Number 250082
      • Tours, France, 37000
        • Investigational Site Number 250027
      • Tours, France, 37000
        • Investigational Site Number 250075
      • VICHY Cedex, France, 03201
        • Investigational Site Number 250046
      • Valenciennes, France, 59322
        • Investigational Site Number 250041
      • Vandoeuvre Les Nancy Cedex, France, 54511
        • Investigational Site Number 250021
      • Venissieux, France, 69200
        • Investigational Site Number 250023
      • Vichy, France, 03200
        • Investigational Site Number 250039
      • Villeneuve sur Lot, France, 47300
        • Investigational Site Number 250100
      • Warloy Baillon, France, 80300
        • Investigational Site Number 250007

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 :

  • 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%

Exclusion criteria:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin glargine (U300)
Type 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
Drug: insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
  • HOE901; Toujeo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in HbA1c
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)
Time Frame: At Weeks 12 and 24
At Weeks 12 and 24
Percentage of patients with HbA1c <7%, <7.5%, and <8%
Time Frame: At Week 24
At Week 24
Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)
Time Frame: Baseline to Week 12 and Week 24
Baseline to Week 12 and Week 24
Mean change from baseline in fasting plasma glucose
Time Frame: Baseline to Week 12 and Week 24
Baseline to Week 12 and Week 24
Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in Diabetes Treatment Satisfaction Questionnaire score
Time Frame: Week 24
Week 24
Number of hypoglycemic events
Time Frame: From inclusion up to Week 24
From inclusion up to Week 24
Number of adverse events
Time Frame: From inclusion up to Week 24
From inclusion up to Week 24

Collaborators and Investigators

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

Sponsor

Sanofi

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

January 4, 2016

Primary Completion (Actual)

July 24, 2017

Study Completion (Actual)

July 24, 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

  • GLARGL07667
  • 2015-002416-33 (EudraCT Number)
  • U1111-1176-6203 (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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