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Completed

NCT Number: NCT02322762

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

DISCOVER is a Non Interventional Study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Algiers, Algeria

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About this study

DISCOVER is a NIS study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment. This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study. The patients will be recruitted from countries in Latin America, Europe and Asia pac. It is estimated that approximately 13350 patients will be enrolled in total with each patient followed up for 3 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of subject informed consent
  • Female or male aged 18 years and over
  • Diagnosed with type 2 diabetes mellitus
  • Initiating a second line anti-diabetic therapy, either as add-on, or switching from one monotherapy to another.

Exclusion criteria

  • Diagnosis of type 1 diabetes mellitus
  • Patient is pregnant
  • Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
  • Current treatment with chemotherapy, oral or iv steroids
  • Patient is on dialysis or has had a renal transplant
  • The patient is taking insulin as first line treatment
  • The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
  • The patient is taking herbal remedies / natural medicines as first line treatment
  • Participation in an interventional trial
  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient for 3 years (e.g. lifethreatening co-morbidities, tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, dementia, alcohol or drug abuse).
  • Not willing to sign the informed consent.

Treatment and study plan

Primary outcomes

  1. Anti-diabetic treatments prescribed by physicians in a real-world setting.

    Time frame: Up to 3 Years

    The drugs (or their combinations) prescribed by physicians to patients initiating a 2nd line anti-diabetic treatment in a real-world setting will be described at inclusion and during 3 years follow-up.

Secondary outcomes

  1. Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.

    Time frame: Up to 3 years

  2. Changes in anti-diabetic treatments

    Time frame: Up to 3 years

  3. Disease progression (incidence of microvascular and macrovascular complications).

    Time frame: Up to 3 years

  4. Incidence of hypoglycemic events.

    Time frame: Up to 3 years

  5. Quality of Life, using Patient Reported Outcomes questionnaires.

    Time frame: Up to 3 years

  6. Use of Healthcare resources.

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: DISCOVER

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2014
Registry last updated
Jun 9, 2022

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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