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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01552005
First received: February 9, 2012
Last updated: July 31, 2012
Last verified: July 2012

February 9, 2012
July 31, 2012
May 2012
July 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    HbA1c level <7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Retention rate of Saxagliptin and to describe discontinuation rate and reasons [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]
  • Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Onglyza® [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    HbA1c level <7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Onglyza®
  • Joint population of Onglyza® 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) ] [ Designated as safety issue: No ]
  • Utilization of Onglyza® 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) ] [ Designated as safety issue: No ]
  • Retention rate of Onglyza® and to describe discontinuation rate and reasons [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01552005 on ClinicalTrials.gov Archive Site
  • Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies [ Time Frame: 2 month ] [ Designated as safety issue: No ]
  • Saxagliptin utilization according to patient's profile and disease characteristics [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies [ Time Frame: 2 month ] [ Designated as safety issue: No ]
  • Onglyza® utilization according to patient's profile and disease characteristics [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France

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

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

Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

The study will be proposed by GPs and diabetologists in France to ambulatory patients

Type 2 Diabetes Mellitus (T2D)
Drug: Saxagliptin
No Intervention
Population of patients treated with Saxagliptin
Intervention: Drug: Saxagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01552005
CV181-148
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP