DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

Conditions
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Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One single cohort.<br>One single cohort of patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-diabetic treatments prescribed by physicians in a real-world setting. | 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. | Up to 3 Years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Anti-diabetic management patterns