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: September 24, 2014
Last verified: September 2014
  Purpose

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 Intervention
Type 2 Diabetes Mellitus (T2D)
Drug: Saxagliptin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Population of patients treated with Saxagliptin Drug: Saxagliptin
No Intervention

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552005

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01552005     History of Changes
Other Study ID Numbers: CV181-148
Study First Received: February 9, 2012
Last Updated: September 24, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on October 21, 2014