Diabetes Mellitus, Type 2 Clinical Trial
— Transition IIOfficial 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
| Verified date | April 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | July 24, 2017 |
| Est. primary completion date | July 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Investigational Site Number 250017 | Alencon Cedex | |
| France | Investigational Site Number 250073 | Ales | |
| France | Investigational Site Number 250047 | Amiens Cedex 1 | |
| 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 | Besancon | |
| France | Investigational Site Number 250081 | BETHUNE Cedex | |
| France | Investigational Site Number 250034 | Bondy | |
| France | Investigational Site Number 250022 | Brest | |
| France | Investigational Site Number 250070 | Brest Cedex | |
| France | Investigational Site Number 250060 | CAHORS Cedex 9 | |
| France | Investigational Site Number 250096 | Cannes | |
| France | Investigational Site Number 250037 | CHALONS EN CHAMPAGNE Cedex | |
| France | Investigational Site Number 250072 | Chambery | |
| 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 | Etampes | |
| France | Investigational Site Number 250104 | Grenoble | |
| France | Investigational Site Number 250004 | La Roche Sur Yon | |
| France | Investigational Site Number 250002 | La Rochelle Cedex 1 | |
| France | Investigational Site Number 250019 | La Seyne sur Mer | |
| France | Investigational Site Number 250030 | Lamagistere | |
| France | Investigational Site Number 250103 | LE CHESNAY Cedex | |
| France | Investigational Site Number 250053 | Le Creusot | |
| France | Investigational Site Number 250044 | Le Mans Cedex 9 | |
| France | Investigational Site Number 250056 | Lens | |
| France | Investigational Site Number 250051 | Lourdes | |
| France | Investigational Site Number 250071 | Mantes La Jolie | |
| France | Investigational Site Number 250064 | Marseille | |
| France | Investigational Site Number 250092 | Marseille | |
| France | Investigational Site Number 250089 | Maubeuge | |
| France | Investigational Site Number 250083 | Merignac | |
| France | Investigational Site Number 250008 | Montpellier | |
| France | Investigational Site Number 250010 | Montpellier | |
| France | Investigational Site Number 250035 | Montpellier | |
| France | Investigational Site Number 250061 | Montpellier | |
| France | Investigational Site Number 250032 | Mulhouse | |
| France | Investigational Site Number 250043 | Nancy | |
| France | Investigational Site Number 250005 | NARBONNE Cedex | |
| France | Investigational Site Number 250069 | Nevers | |
| France | Investigational Site Number 250052 | Nimes | |
| France | Investigational Site Number 250059 | Noisy Le Grand | |
| France | Investigational Site Number 250058 | Orleans | |
| France | Investigational Site Number 250026 | Paris | |
| France | Investigational Site Number 250031 | Paris | |
| France | Investigational Site Number 250086 | Paris | |
| France | Investigational Site Number 250105 | Paris | |
| France | Investigational Site Number 250084 | PERIGUEUX Cedex | |
| France | Investigational Site Number 250101 | Pessac Cedex | |
| France | Investigational Site Number 250107 | Pointe À Pitre | |
| 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 250108 | Saint Pierre | |
| France | Investigational Site Number 250065 | Saint-Denis | |
| France | Investigational Site Number 250029 | Saint-Mandé | |
| France | Investigational Site Number 250087 | Seclin | |
| France | Investigational Site Number 250090 | Sete | |
| France | Investigational Site Number 250006 | Strasbourg | |
| France | Investigational Site Number 250024 | Strasbourg Cedex 2 | |
| France | Investigational Site Number 250033 | Suresnes | |
| France | Investigational Site Number 250057 | Tarbes | |
| France | Investigational Site Number 250001 | Toulouse | |
| France | Investigational Site Number 250050 | Toulouse | |
| France | Investigational Site Number 250076 | Toulouse | |
| France | Investigational Site Number 250082 | Toulouse Cedex 3 | |
| France | Investigational Site Number 250027 | Tours | |
| France | Investigational Site Number 250075 | Tours | |
| France | Investigational Site Number 250041 | Valenciennes | |
| France | Investigational Site Number 250021 | Vandoeuvre Les Nancy Cedex | |
| France | Investigational Site Number 250023 | Venissieux | |
| France | Investigational Site Number 250039 | Vichy | |
| France | Investigational Site Number 250046 | VICHY Cedex | |
| France | Investigational Site Number 250100 | Villeneuve sur Lot | |
| France | Investigational Site Number 250007 | Warloy Baillon |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change from baseline in HbA1c | Baseline, Week 24 | ||
| Secondary | Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL) | At Weeks 12 and 24 | ||
| Secondary | Percentage of patients with HbA1c <7%, <7.5%, and <8% | At Week 24 | ||
| Secondary | Mean change from baseline in HbA1c across HbA1c subgroups category (=8%, >8 to 9%, and >9%) | Baseline to Week 12 and Week 24 | ||
| Secondary | Mean change from baseline in fasting plasma glucose | Baseline to Week 12 and Week 24 | ||
| Secondary | 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 | ||
| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire score | Week 24 | ||
| Secondary | Number of hypoglycemic events | From inclusion up to Week 24 | ||
| Secondary | Number of adverse events | From inclusion up to Week 24 |
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