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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
insulin glargine (U300)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 250017
  • Investigational Site Number 250073
  • Investigational Site Number 250047
  • Investigational Site Number 250028
  • Investigational Site Number 250062
  • Investigational Site Number 250093
  • Investigational Site Number 250020
  • Investigational Site Number 250081
  • Investigational Site Number 250034
  • Investigational Site Number 250070
  • Investigational Site Number 250022
  • Investigational Site Number 250060
  • Investigational Site Number 250096
  • Investigational Site Number 250037
  • Investigational Site Number 250072
  • Investigational Site Number 250018
  • Investigational Site Number 250068
  • Investigational Site Number 250098
  • Investigational Site Number 250048
  • Investigational Site Number 250088
  • Investigational Site Number 250054
  • Investigational Site Number 250063
  • Investigational Site Number 250013
  • Investigational Site Number 250095
  • Investigational Site Number 250104
  • Investigational Site Number 250004
  • Investigational Site Number 250002
  • Investigational Site Number 250019
  • Investigational Site Number 250030
  • Investigational Site Number 250103
  • Investigational Site Number 250053
  • Investigational Site Number 250044
  • Investigational Site Number 250056
  • Investigational Site Number 250051
  • Investigational Site Number 250071
  • Investigational Site Number 250092
  • Investigational Site Number 250064
  • Investigational Site Number 250089
  • Investigational Site Number 250083
  • Investigational Site Number 250035
  • Investigational Site Number 250061
  • Investigational Site Number 250010
  • Investigational Site Number 250008
  • Investigational Site Number 250032
  • Investigational Site Number 250043
  • Investigational Site Number 250005
  • Investigational Site Number 250069
  • Investigational Site Number 250052
  • Investigational Site Number 250059
  • Investigational Site Number 250058
  • Investigational Site Number 250031
  • Investigational Site Number 250105
  • Investigational Site Number 250086
  • Investigational Site Number 250026
  • Investigational Site Number 250084
  • Investigational Site Number 250101
  • Investigational Site Number 250107
  • Investigational Site Number 250067
  • Investigational Site Number 250078
  • Investigational Site Number 250042
  • Investigational Site Number 250012
  • Investigational Site Number 250055
  • Investigational Site Number 250102
  • Investigational Site Number 250108
  • Investigational Site Number 250065
  • Investigational Site Number 250029
  • Investigational Site Number 250087
  • Investigational Site Number 250090
  • Investigational Site Number 250024
  • Investigational Site Number 250006
  • Investigational Site Number 250033
  • Investigational Site Number 250057
  • Investigational Site Number 250082
  • Investigational Site Number 250001
  • Investigational Site Number 250076
  • Investigational Site Number 250050
  • Investigational Site Number 250027
  • Investigational Site Number 250075
  • Investigational Site Number 250041
  • Investigational Site Number 250021
  • Investigational Site Number 250023
  • Investigational Site Number 250046
  • Investigational Site Number 250039
  • Investigational Site Number 250100
  • Investigational Site Number 250007

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin glargine (U300)

Arm Description

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

Outcomes

Primary Outcome Measures

Mean change from baseline in HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2016
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02967237
Brief Title
Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
Acronym
Transition II
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (undefined)
Primary Completion Date
July 24, 2017 (Actual)
Study Completion Date
July 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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
Detailed Description
The total study duration per patient is approximately 28 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin glargine (U300)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
insulin glargine (U300)
Other Intervention Name(s)
HOE901; Toujeo
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Mean change from baseline in HbA1c
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)
Time Frame
At Weeks 12 and 24
Title
Percentage of patients with HbA1c <7%, <7.5%, and <8%
Time Frame
At Week 24
Title
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
Title
Mean change from baseline in fasting plasma glucose
Time Frame
Baseline to Week 12 and Week 24
Title
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
Title
Change in Diabetes Treatment Satisfaction Questionnaire score
Time Frame
Week 24
Title
Number of hypoglycemic events
Time Frame
From inclusion up to Week 24
Title
Number of adverse events
Time Frame
From inclusion up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 250017
City
Alencon Cedex
ZIP/Postal Code
61014
Country
France
Facility Name
Investigational Site Number 250073
City
Ales
ZIP/Postal Code
30100
Country
France
Facility Name
Investigational Site Number 250047
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Investigational Site Number 250028
City
Amilly
Country
France
Facility Name
Investigational Site Number 250062
City
Bagnols-sur-Cèze
Country
France
Facility Name
Investigational Site Number 250093
City
Bar le Duc
Country
France
Facility Name
Investigational Site Number 250020
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Investigational Site Number 250081
City
BETHUNE Cedex
ZIP/Postal Code
62408
Country
France
Facility Name
Investigational Site Number 250034
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Investigational Site Number 250070
City
Brest Cedex
ZIP/Postal Code
29610
Country
France
Facility Name
Investigational Site Number 250022
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Investigational Site Number 250060
City
CAHORS Cedex 9
ZIP/Postal Code
46005
Country
France
Facility Name
Investigational Site Number 250096
City
Cannes
ZIP/Postal Code
06401
Country
France
Facility Name
Investigational Site Number 250037
City
CHALONS EN CHAMPAGNE Cedex
ZIP/Postal Code
51005
Country
France
Facility Name
Investigational Site Number 250072
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Investigational Site Number 250018
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Investigational Site Number 250068
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Investigational Site Number 250098
City
Cognac
ZIP/Postal Code
16112
Country
France
Facility Name
Investigational Site Number 250048
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Investigational Site Number 250088
City
Contamines Sur Arve
ZIP/Postal Code
74130
Country
France
Facility Name
Investigational Site Number 250054
City
Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Investigational Site Number 250063
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Investigational Site Number 250013
City
Eaubonne
Country
France
Facility Name
Investigational Site Number 250095
City
Etampes
Country
France
Facility Name
Investigational Site Number 250104
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Investigational Site Number 250004
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Investigational Site Number 250002
City
La Rochelle Cedex 1
ZIP/Postal Code
17019
Country
France
Facility Name
Investigational Site Number 250019
City
La Seyne sur Mer
Country
France
Facility Name
Investigational Site Number 250030
City
Lamagistere
ZIP/Postal Code
82360
Country
France
Facility Name
Investigational Site Number 250103
City
LE CHESNAY Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Investigational Site Number 250053
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Investigational Site Number 250044
City
Le Mans Cedex 9
ZIP/Postal Code
72037
Country
France
Facility Name
Investigational Site Number 250056
City
Lens
Country
France
Facility Name
Investigational Site Number 250051
City
Lourdes
ZIP/Postal Code
65000
Country
France
Facility Name
Investigational Site Number 250071
City
Mantes La Jolie
Country
France
Facility Name
Investigational Site Number 250092
City
Marseille
ZIP/Postal Code
13006
Country
France
Facility Name
Investigational Site Number 250064
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Investigational Site Number 250089
City
Maubeuge
ZIP/Postal Code
59600
Country
France
Facility Name
Investigational Site Number 250083
City
Merignac
ZIP/Postal Code
33700
Country
France
Facility Name
Investigational Site Number 250035
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Investigational Site Number 250061
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
Investigational Site Number 250010
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250008
City
Montpellier
Country
France
Facility Name
Investigational Site Number 250032
City
Mulhouse
Country
France
Facility Name
Investigational Site Number 250043
City
Nancy
Country
France
Facility Name
Investigational Site Number 250005
City
NARBONNE Cedex
ZIP/Postal Code
11018
Country
France
Facility Name
Investigational Site Number 250069
City
Nevers
ZIP/Postal Code
58000
Country
France
Facility Name
Investigational Site Number 250052
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number 250059
City
Noisy Le Grand
Country
France
Facility Name
Investigational Site Number 250058
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Investigational Site Number 250031
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Investigational Site Number 250105
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Investigational Site Number 250086
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Investigational Site Number 250026
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Investigational Site Number 250084
City
PERIGUEUX Cedex
ZIP/Postal Code
24019
Country
France
Facility Name
Investigational Site Number 250101
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Investigational Site Number 250107
City
Pointe À Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Investigational Site Number 250067
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Investigational Site Number 250078
City
PRINGY Cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Investigational Site Number 250042
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Investigational Site Number 250012
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Investigational Site Number 250055
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Investigational Site Number 250102
City
Saint Brieuc
Country
France
Facility Name
Investigational Site Number 250108
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Investigational Site Number 250065
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Investigational Site Number 250029
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
Facility Name
Investigational Site Number 250087
City
Seclin
ZIP/Postal Code
59113
Country
France
Facility Name
Investigational Site Number 250090
City
Sete
ZIP/Postal Code
34200
Country
France
Facility Name
Investigational Site Number 250024
City
Strasbourg Cedex 2
ZIP/Postal Code
67098
Country
France
Facility Name
Investigational Site Number 250006
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Investigational Site Number 250033
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Investigational Site Number 250057
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Investigational Site Number 250082
City
Toulouse Cedex 3
ZIP/Postal Code
31076
Country
France
Facility Name
Investigational Site Number 250001
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Investigational Site Number 250076
City
Toulouse
ZIP/Postal Code
31027
Country
France
Facility Name
Investigational Site Number 250050
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Investigational Site Number 250027
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Investigational Site Number 250075
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Investigational Site Number 250041
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Investigational Site Number 250021
City
Vandoeuvre Les Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number 250023
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Investigational Site Number 250046
City
VICHY Cedex
ZIP/Postal Code
03201
Country
France
Facility Name
Investigational Site Number 250039
City
Vichy
ZIP/Postal Code
03200
Country
France
Facility Name
Investigational Site Number 250100
City
Villeneuve sur Lot
ZIP/Postal Code
47300
Country
France
Facility Name
Investigational Site Number 250007
City
Warloy Baillon
ZIP/Postal Code
80300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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