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OpenTrials
Completed

NCT Number: NCT01552005

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

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Key information

Conditions

Type 2 Diabetes Mellitus (T2D) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

No Intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: DIAPAZON

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2012
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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