Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: Assess effectiveness in achieving glycemic goal measured by HbA1c; Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; Assess requirement for intensification of therapy by additional antidiabetics. Assess incidence of hypoglycemia; Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); Assess change in body weight.

Detailed Description
-----------------
Patients will be observed for one year

Official Title
-----------------
A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Insulin glargine (U300)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Signed patient informed consent; Type 2 diabetes mellitus; Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months; Hemoglobin A1c (HbA1c) >7.0 % and ≤11% within 3 months of study baseline; Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen Exclusion criteria: Diabetes mellitus other than type 2; Contraindication to insulin glargine U300 according to local product labelling; 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin glargine (U300)<br>Insulin glargine (U300) dosage and dosing time as per local product labeling | Drug: Insulin glargine (U300)<br>* Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection<br>* Other names: HOE901, Toujeo, Toujeo Solostar;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c at month 6 | Percentage of patients achieving Hemoglobin A1c <7.0%. | Baseline, month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change from baseline in HbA1c at 3, 6, and 12 months | Baseline, months 3, 6, 12 | 
| Change in fasting plasma glucose | Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months | Baseline, months 3, 6, 12 | 
| Change in Self-Monitored Plasma Glucose | Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months | Baseline, months 3, 6, 12 | 
| Hypoglycemia | Number of participants with symptomatic hypoglycemic events | Baseline to month 12 | 
| Adverse events | Number of participants with Adverse Events | Baseline to month 12 | 
| Serious adverse events | Number of participants with Serious Adverse Events | Baseline to month 12 | 
| Body weight | Change in average body weight | Baseline to month 12 |