Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
NCT ID: NCT02967237
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
136 participants
INTERVENTIONAL
2016-01-04
2017-07-24
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
Interventions
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insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c \> 7.5%
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 250017
Alençon, , France
Investigational Site Number 250073
Alès, , France
Investigational Site Number 250047
Amiens, , France
Investigational Site Number 250028
Amilly, , France
Investigational Site Number 250062
Bagnols-sur-Cèze, , France
Investigational Site Number 250093
Bar-le-Duc, , France
Investigational Site Number 250020
Besançon, , France
Investigational Site Number 250081
Béthune, , France
Investigational Site Number 250034
Bondy, , France
Investigational Site Number 250022
Brest, , France
Investigational Site Number 250070
Brest, , France
Investigational Site Number 250060
Cahors, , France
Investigational Site Number 250096
Cannes, , France
Investigational Site Number 250072
Chambéry, , France
Investigational Site Number 250037
Châlons-en-Champagne, , France
Investigational Site Number 250018
Cholet, , France
Investigational Site Number 250068
Clermont-Ferrand, , France
Investigational Site Number 250098
Cognac, , France
Investigational Site Number 250048
Colmar, , France
Investigational Site Number 250088
Contamines Sur Arve, , France
Investigational Site Number 250054
Coudray, , France
Investigational Site Number 250063
Dijon, , France
Investigational Site Number 250013
Eaubonne, , France
Investigational Site Number 250095
Étampes, , France
Investigational Site Number 250104
Grenoble, , France
Investigational Site Number 250004
La Roche-sur-Yon, , France
Investigational Site Number 250002
La Rochelle, , France
Investigational Site Number 250019
La Seyne-sur-Mer, , France
Investigational Site Number 250030
Lamagistère, , France
Investigational Site Number 250103
Le Chesnay, , France
Investigational Site Number 250053
Le Creusot, , France
Investigational Site Number 250044
Le Mans, , France
Investigational Site Number 250056
Lens, , France
Investigational Site Number 250051
Lourdes, , France
Investigational Site Number 250071
Mantes-la-Jolie, , France
Investigational Site Number 250092
Marseille, , France
Investigational Site Number 250064
Marseille, , France
Investigational Site Number 250089
Maubeuge, , France
Investigational Site Number 250083
Mérignac, , France
Investigational Site Number 250035
Montpellier, , France
Investigational Site Number 250061
Montpellier, , France
Investigational Site Number 250010
Montpellier, , France
Investigational Site Number 250008
Montpellier, , France
Investigational Site Number 250032
Mulhouse, , France
Investigational Site Number 250043
Nancy, , France
Investigational Site Number 250005
Narbonne, , France
Investigational Site Number 250069
Nevers, , France
Investigational Site Number 250052
Nîmes, , France
Investigational Site Number 250059
Noisy-le-Grand, , France
Investigational Site Number 250058
Orléans, , France
Investigational Site Number 250031
Paris, , France
Investigational Site Number 250105
Paris, , France
Investigational Site Number 250086
Paris, , France
Investigational Site Number 250026
Paris, , France
Investigational Site Number 250101
Pessac, , France
Investigational Site Number 250084
Périgueux, , France
Investigational Site Number 250107
Pointe à Pitre, , France
Investigational Site Number 250067
Pontoise, , France
Investigational Site Number 250078
Pringy, , France
Investigational Site Number 250042
Reims, , France
Investigational Site Number 250012
Roubaix, , France
Investigational Site Number 250055
Roubaix, , France
Investigational Site Number 250102
Saint-Brieuc, , France
Investigational Site Number 250065
Saint-Denis, , France
Investigational Site Number 250029
Saint-Mandé, , France
Investigational Site Number 250108
Saint-Pierre, , France
Investigational Site Number 250087
Seclin, , France
Investigational Site Number 250090
Sète, , France
Investigational Site Number 250006
Strasbourg, , France
Investigational Site Number 250024
Strasbourg, , France
Investigational Site Number 250033
Suresnes, , France
Investigational Site Number 250057
Tarbes, , France
Investigational Site Number 250001
Toulouse, , France
Investigational Site Number 250076
Toulouse, , France
Investigational Site Number 250082
Toulouse, , France
Investigational Site Number 250050
Toulouse, , France
Investigational Site Number 250027
Tours, , France
Investigational Site Number 250075
Tours, , France
Investigational Site Number 250041
Valenciennes, , France
Investigational Site Number 250021
Vandœuvre-lès-Nancy, , France
Investigational Site Number 250023
Vénissieux, , France
Investigational Site Number 250039
Vichy, , France
Investigational Site Number 250046
Vichy, , France
Investigational Site Number 250100
Villeneuve-sur-Lot, , France
Investigational Site Number 250007
Warloy-Baillon, , France
Countries
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Other Identifiers
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2015-002416-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1176-6203
Identifier Type: OTHER
Identifier Source: secondary_id
GLARGL07667
Identifier Type: -
Identifier Source: org_study_id
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