Type 2 Diabetes Mellitus (T2D)
Conditions
Brief summary
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
Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.
Interventions
DRUGSaxagliptin
No Intervention
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin | 24 months | HbA1c level \<7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin |
| 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
| Measure | 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 |
Outcome results
None listed