Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Anti-diabetic management patterns
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in anti-diabetic treatments | Up to 3 years |
| Disease progression (incidence of microvascular and macrovascular complications). | Up to 3 years |
| Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure. | Up to 3 years |
| Quality of Life, using Patient Reported Outcomes questionnaires. | Up to 3 years |
| Use of Healthcare resources. | Up to 3 years |
| Incidence of hypoglycemic events. | Up to 3 years |
Countries
Algeria, Argentina, Australia, Austria, Bahrain, Brazil, China, Colombia, Costa Rica, Czechia, Egypt, India, Indonesia, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Oman, Panama, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed