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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552005
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : June 7, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus (T2D) Drug: Saxagliptin

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

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Official Title: Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Group/Cohort Intervention/treatment
Population of patients treated with Saxagliptin Drug: Saxagliptin
No Intervention

Primary Outcome Measures :
  1. 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 ]
    HbA1c level <7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin

  2. 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) ]
  3. 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) ]
  4. Retention rate of Saxagliptin and to describe discontinuation rate and reasons [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  1. Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies [ Time Frame: 2 month ]
  2. Saxagliptin utilization according to patient's profile and disease characteristics [ Time Frame: 24 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be proposed by GPs and diabetologists in France to ambulatory patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552005

Sponsors and Collaborators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01552005     History of Changes
Other Study ID Numbers: CV181-148
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents