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

Type 2 Diabetes Mellitus (T2D) Clinical Trial

— DIAPAZON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552005
• Other study ID #: CV181-148
• Status: Completed
• Phase: N/A
• First received: February 9, 2012
• Last updated: June 6, 2016
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2D)

Intervention

Drug:
• Saxagliptin
No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	No
Primary	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)	No
Primary	Retention rate of Saxagliptin and to describe discontinuation rate and reasons		At 2 years	Yes
Secondary	Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies		2 month	No
Secondary	Saxagliptin utilization according to patient's profile and disease characteristics		24 month	No

External Links

•   BMS Clinical Trials Disclosure
•   CSR_Synopsis
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form