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

Study Overview
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Brief Summary
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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
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The total study duration per patient is approximately 28 weeks.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin glargine (U300)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine (U300)<br>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 | Drug: insulin glargine (U300)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901; Toujeo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in HbA1c |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL) |  | At Weeks 12 and 24 | 
| Percentage of patients with HbA1c <7%, <7.5%, and <8% |  | At 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 | 
| Mean change from baseline in fasting plasma glucose |  | Baseline to Week 12 and 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 | 
| Change in Diabetes Treatment Satisfaction Questionnaire score |  | Week 24 | 
| Number of hypoglycemic events |  | From inclusion up to Week 24 | 
| Number of adverse events |  | From inclusion up to Week 24 |