Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
- Registration Number
- NCT02967237
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin glargine (U300) 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
- Primary Outcome Measures
Name Time Method Mean change from baseline in HbA1c Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Number of adverse events From inclusion up to Week 24 Percentage of patients with HbA1c <7%, <7.5%, and <8% At Week 24 Mean change from baseline in fasting plasma glucose Baseline to Week 12 and Week 24 Change in Diabetes Treatment Satisfaction Questionnaire score Week 24 Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Baseline to Week 24 Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%) Baseline to Week 12 and Week 24 Number of hypoglycemic events From inclusion up to Week 24 Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL) At Weeks 12 and 24
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (85)
Investigational Site Number 250062
🇫🇷Bagnols-sur-Cèze, France
Investigational Site Number 250081
🇫🇷BETHUNE Cedex, France
Investigational Site Number 250093
🇫🇷Bar le Duc, France
Investigational Site Number 250018
🇫🇷Cholet, France
Investigational Site Number 250063
🇫🇷Dijon, France
Investigational Site Number 250002
🇫🇷La Rochelle Cedex 1, France
Investigational Site Number 250020
🇫🇷Besancon, France
Investigational Site Number 250060
🇫🇷CAHORS Cedex 9, France
Investigational Site Number 250068
🇫🇷Clermont Ferrand, France
Investigational Site Number 250088
🇫🇷Contamines Sur Arve, France
Investigational Site Number 250030
🇫🇷Lamagistere, France
Investigational Site Number 250051
🇫🇷Lourdes, France
Investigational Site Number 250073
🇫🇷Ales, France
Investigational Site Number 250047
🇫🇷Amiens Cedex 1, France
Investigational Site Number 250028
🇫🇷Amilly, France
Investigational Site Number 250035
🇫🇷Montpellier, France
Investigational Site Number 250070
🇫🇷Brest Cedex, France
Investigational Site Number 250096
🇫🇷Cannes, France
Investigational Site Number 250037
🇫🇷CHALONS EN CHAMPAGNE Cedex, France
Investigational Site Number 250071
🇫🇷Mantes La Jolie, France
Investigational Site Number 250053
🇫🇷Le Creusot, France
Investigational Site Number 250108
🇫🇷Saint Pierre, France
Investigational Site Number 250105
🇫🇷Paris, France
Investigational Site Number 250041
🇫🇷Valenciennes, France
Investigational Site Number 250017
🇫🇷Alencon Cedex, France
Investigational Site Number 250034
🇫🇷Bondy, France
Investigational Site Number 250095
🇫🇷Etampes, France
Investigational Site Number 250019
🇫🇷La Seyne sur Mer, France
Investigational Site Number 250056
🇫🇷Lens, France
Investigational Site Number 250083
🇫🇷Merignac, France
Investigational Site Number 250005
🇫🇷NARBONNE Cedex, France
Investigational Site Number 250107
🇫🇷Pointe À Pitre, France
Investigational Site Number 250024
🇫🇷Strasbourg Cedex 2, France
Investigational Site Number 250090
🇫🇷Sete, France
Investigational Site Number 250039
🇫🇷Vichy, France
Investigational Site Number 250022
🇫🇷Brest, France
Investigational Site Number 250072
🇫🇷Chambery, France
Investigational Site Number 250043
🇫🇷Nancy, France
Investigational Site Number 250098
🇫🇷Cognac, France
Investigational Site Number 250054
🇫🇷Coudray, France
Investigational Site Number 250013
🇫🇷Eaubonne, France
Investigational Site Number 250048
🇫🇷Colmar, France
Investigational Site Number 250104
🇫🇷Grenoble, France
Investigational Site Number 250004
🇫🇷La Roche Sur Yon, France
Investigational Site Number 250103
🇫🇷LE CHESNAY Cedex, France
Investigational Site Number 250044
🇫🇷Le Mans Cedex 9, France
Investigational Site Number 250092
🇫🇷Marseille, France
Investigational Site Number 250064
🇫🇷Marseille, France
Investigational Site Number 250089
🇫🇷Maubeuge, France
Investigational Site Number 250069
🇫🇷Nevers, 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 250052
🇫🇷Nimes, France
Investigational Site Number 250059
🇫🇷Noisy Le Grand, France
Investigational Site Number 250058
🇫🇷Orleans, France
Investigational Site Number 250031
🇫🇷Paris, France
Investigational Site Number 250026
🇫🇷Paris, France
Investigational Site Number 250084
🇫🇷PERIGUEUX Cedex, France
Investigational Site Number 250101
🇫🇷Pessac Cedex, France
Investigational Site Number 250086
🇫🇷Paris, France
Investigational Site Number 250067
🇫🇷Pontoise, France
Investigational Site Number 250078
🇫🇷PRINGY Cedex, France
Investigational Site Number 250042
🇫🇷Reims Cedex, 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 250087
🇫🇷Seclin, France
Investigational Site Number 250006
🇫🇷Strasbourg, France
Investigational Site Number 250033
🇫🇷Suresnes, France
Investigational Site Number 250001
🇫🇷Toulouse, France
Investigational Site Number 250057
🇫🇷Tarbes, France
Investigational Site Number 250082
🇫🇷Toulouse Cedex 3, France
Investigational Site Number 250027
🇫🇷Tours, France
Investigational Site Number 250076
🇫🇷Toulouse, France
Investigational Site Number 250050
🇫🇷Toulouse, France
Investigational Site Number 250075
🇫🇷Tours, France
Investigational Site Number 250021
🇫🇷Vandoeuvre Les Nancy Cedex, France
Investigational Site Number 250023
🇫🇷Venissieux, France
Investigational Site Number 250046
🇫🇷VICHY Cedex, France
Investigational Site Number 250100
🇫🇷Villeneuve sur Lot, France
Investigational Site Number 250007
🇫🇷Warloy Baillon, France