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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2016 |
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Main ID: |
NCT01552005 |
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Date of registration:
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09/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
DIAPAZON |
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Scientific title:
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Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01552005 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort
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Phase:
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N/A
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus (T2D)
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Intervention(s)
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Drug: Saxagliptin
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Primary Outcome(s)
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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)]
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Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin
[Time Frame: 24 months]
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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)]
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Retention rate of Saxagliptin and to describe discontinuation rate and reasons
[Time Frame: At 2 years]
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Secondary Outcome(s)
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Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies
[Time Frame: 2 month]
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Saxagliptin utilization according to patient's profile and disease characteristics
[Time Frame: 24 month]
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Secondary ID(s)
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CV181-148
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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