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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
Scientific title
DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
One single cohort. - One single cohort of patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy.

Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 3 Years
Secondary outcome [1] 0 0
Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Changes in anti-diabetic treatments
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Disease progression (incidence of microvascular and macrovascular complications).
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Incidence of hypoglycemic events.
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Quality of Life, using Patient Reported Outcomes questionnaires.
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Use of Healthcare resources.
Timepoint [6] 0 0
Up to 3 years

Key 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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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

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
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Jesus Medina, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications