Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Sponsor AstraZeneca
Start date December 2014
End date June 2019
Trial size 13350 participants
Trial identifier NCT02322762, D1690R00002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
One single cohort of patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy.

Primary Outcomes

Measure
Anti-diabetic treatments prescribed by physicians in a real-world setting.
time frame: Up to 3 Years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
Principal investigator Linong Ji, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.