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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: insulin glargine (U300)

• 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.

Study Timeline

• Study Start: 2016-01-04
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

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

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