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

NCT ID: NCT01552005

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

Brief Summary

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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

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

Conditions

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Type 2 Diabetes Mellitus (T2D)

Study Design

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Observational Model Type

COHORT

Study Groups

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Population of patients treated with Saxagliptin

Saxagliptin

Intervention Type DRUG

No Intervention

Interventions

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Saxagliptin

No Intervention

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

Other Identifiers

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CV181-148

Identifier Type: -

Identifier Source: org_study_id

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