Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
DIAPAZON
1 other identifier
observational
1,000
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 7, 2016
June 1, 2016
3.1 years
February 9, 2012
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (2)
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
Study Arms (1)
Population of patients treated with Saxagliptin
Interventions
Eligibility Criteria
The study will be proposed by GPs and diabetologists in France to ambulatory patients
You may qualify if:
- Registry
- Patient ≥ 18 years old
- Patient with T2D
- Ambispective Cohort
- Patient ≥ 18 years old
- Patient with T2D
- Patient agreeing to participate, and not yet enrolled by another physician
You may not qualify if:
- Patient participating in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2012
First Posted
March 13, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 7, 2016
Record last verified: 2016-06