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

N/ACompletedNCT01552005

AstraZeneca1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Type 2 Diabetes Mellitus (T2D)

Interventions

SaxagliptinDRUG

No Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: During the treatment (Up to 2 years)

Retention rate of Saxagliptin and to describe discontinuation rate and reasons

Time frame: At 2 years

Secondary Outcomes

Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies

Time frame: 2 month

Saxagliptin utilization according to patient's profile and disease characteristics

Time frame: 24 month

Data from ClinicalTrials.gov

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