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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
Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population of patients treated with Saxagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | No Intervention |
|
| 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 |
| 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 |
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Inclusion Criteria:
Registry
Ambispective Cohort
Exclusion Criteria:
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The study will be proposed by GPs and diabetologists in France to ambulatory patients
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| CSR\_Synopsis | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
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| D004700 | Endocrine System Diseases |