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 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 250070; 🇫🇷 Brest Cedex, France

Scroll for more (75 remaining)