Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France

Study Overview
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Brief Summary
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The purpose of this study is to respond to The French Health Authority which has requested BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with Saxagliptin to generate real world data on drug utilization, joint population, non comparative effectiveness and safety

Detailed Description
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Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.

Official Title
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Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France

Conditions
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Type 2 Diabetes Mellitus (T2D)

Intervention / Treatment
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* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registry Patient ≥ 18 years old Patient with T2D Ambispective Cohort Patient ≥ 18 years old Patient with T2D Patient initiated with Saxagliptin in the last 6 months before the inclusion or day of inclusion visit (whatever his/her ongoing hypoglycaemic treatment) Patient agreeing to participate, and not yet enrolled by another physician Exclusion Criteria: Patient participating 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population of patients treated with Saxagliptin<br> | Drug: Saxagliptin<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin | HbA1c level <7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin | 24 months | 
| Joint population of Saxagliptin based on socio-demographic data, medical history, disease history, comorbidities including renal, hepatic and cardiac functions, HbA1c level at treatment initiation) |  | One year (average) | 
| Utilization of Saxagliptin by General practitioners (GPs) and diabetologists in France (based on indication, initial dosage and adjustments, co-prescriptions, glycemic monitoring) |  | During the treatment (Up to 2 years) | 
| Retention rate of Saxagliptin and to describe discontinuation rate and reasons |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies |  | 2 month | 
| Saxagliptin utilization according to patient's profile and disease characteristics |  | 24 month |