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

Completed

• Conditions: Type 2 Diabetes Mellitus (T2D)
• Interventions: Drug: Saxagliptin

• Registration Number: NCT01552005
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Study Start: 2012-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population of patients treated with Saxagliptin	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
Retention rate of Saxagliptin and to describe discontinuation rate and reasons	At 2 years
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)
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
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)

Secondary Outcome Measures

Name	Time	Method
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