Evaluation of Toujeo insulin in type 2 diabetes patients inadequately control with their basal insulin treatment

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002416-33-FR

Enrollment

350

Registered

2015-12-07

Start date

2016-02-15

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: TOUJEO Product Name: Insulin glargine Product Code: HOE901 - U300 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Types 2 diabetes adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without GLP1 receptor agonist - HbA1c > 7,5 % Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to describe the effect of HOE901-U300 in T2DM patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on HbA1c improvement.;Secondary Objective: - Evolution of fasting plasma glucose - Evolution of insulin dose and body weight - Hpoglycemia incidence - Safety - Patient’s satisfaction when they change their insulin for HOE901-U300 - Reach of objective of insulin change, as defined by the investigator - Observance of insulin titration guidelines;Primary end point(s): Mean change of HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 24	—

Measure

Time frame

Main Objective: The primary objective is to describe the effect of HOE901-U300 in T2DM patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on HbA1c improvement.;Secondary Objective: - Evolution of fasting plasma glucose - Evolution of insulin dose and body weight - Hpoglycemia incidence - Safety - Patient’s satisfaction when they change their insulin for HOE901-U300 - Reach of objective of insulin change, as defined by the investigator - Observance of insulin titration guidelines;Primary end point(s): Mean change of HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 24

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Secondary

Measure	Time frame
Secondary end point(s): - Percentage of patients who reach fasting plasma glucose objective (90-130 mg/dL) at weeks 12 (J84) and 24 (J168) - Percentage of patients with HbA1c 8 to 9%, >9 %) - Mean change in fasting plasma glucose from baseline to week 12 and week - Patient reported outcomes: - Mean change from baseline to week 24 regarding total satisfaction regarding treatment, perception of hypoglycemia and hyperglycemia, according to DTSQs questionnaire - DTSQc score at week 24 - Reason of change of insulin as defined by the investigator - Percentage of patients who reach the objective defined by the investigator at screening (reason for change of insulin) at weeks 12 and 24 - Percentage of patients with poor ( 75 %) observance to insulin titration guidelines Influence of the type of investigator’s practice on the care of the patient - Hypoglycemia - Adverse events, serious adverse events, technical complaints - Vital signs - Body weight - Basal insulin dose (dose of HOE901-U300 during the 24 weeks of treatment);Timepoint(s) of evaluation of this end point: week 12 and/or 24 according to the timepoint	—

Measure

Time frame

Secondary end point(s): - Percentage of patients who reach fasting plasma glucose objective (90-130 mg/dL) at weeks 12 (J84) and 24 (J168) - Percentage of patients with HbA1c 8 to 9%, >9 %) - Mean change in fasting plasma glucose from baseline to week 12 and week - Patient reported outcomes: - Mean change from baseline to week 24 regarding total satisfaction regarding treatment, perception of hypoglycemia and hyperglycemia, according to DTSQs questionnaire - DTSQc score at week 24 - Reason of change of insulin as defined by the investigator - Percentage of patients who reach the objective defined by the investigator at screening (reason for change of insulin) at weeks 12 and 24 - Percentage of patients with poor ( 75 %) observance to insulin titration guidelines Influence of the type of investigator’s practice on the care of the patient - Hypoglycemia - Adverse events, serious adverse events, technical complaints - Vital signs - Body weight - Basal insulin dose (dose of HOE901-U300 during the 24 weeks of treatment);Timepoint(s) of evaluation of this end point: week 12 and/or 24 according to the timepoint

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Countries

France

Contacts

Public ContactDirection des Operations Cliniques

sanofi-aventis France

Public-Registry-MA-France@sanofi.com0800 222 555

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026