DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02322762
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-23
• Study Start: 2014-12-30
• Primary Completion: 2019-08-21
• Study Completion: 2019-08-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15992

Inclusion Criteria

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

Exclusion Criteria

1. Diagnosis of type 1 diabetes mellitus
2. Patient is pregnant
3. Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
4. Current treatment with chemotherapy, oral or iv steroids
5. Patient is on dialysis or has had a renal transplant
6. The patient is taking insulin as first line treatment
7. The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
8. The patient is taking herbal remedies / natural medicines as first line treatment
9. Participation in an interventional trial
10. 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).
11. Not willing to sign the informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-diabetic treatments prescribed by physicians in a real-world setting.	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 Outcome Measures

Name	Time	Method
Quality of Life, using Patient Reported Outcomes questionnaires.	Up to 3 years
Use of Healthcare resources.	Up to 3 years
Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.	Up to 3 years
Disease progression (incidence of microvascular and macrovascular complications).	Up to 3 years
Changes in anti-diabetic treatments	Up to 3 years
Incidence of hypoglycemic events.	Up to 3 years

Trial Locations

Locations (1)

Research Site; 🇦🇪 Dubai, United Arab Emirates