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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02322762




Registration number
NCT02322762
Ethics application status
Date submitted
19/12/2014
Date registered
23/12/2014
Date last updated
9/06/2022

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
D1690R00002
Universal Trial Number (UTN)
Trial acronym
DISCOVER
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
Diabetes

Intervention/exposure
Study type
Observational
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

Outcomes
Primary outcome [1] 0 0
Anti-diabetic treatments prescribed by physicians in a real-world setting.
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2019
Sample size
Target
Accrual to date
Final
15992
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Burwood
Recruitment hospital [3] 0 0
Research Site - Castle Hill
Recruitment hospital [4] 0 0
Research Site - Coorparoo
Recruitment hospital [5] 0 0
Research Site - Corio
Recruitment hospital [6] 0 0
Research Site - Cowra
Recruitment hospital [7] 0 0
Research Site - Edmonton
Recruitment hospital [8] 0 0
Research Site - Forbes
Recruitment hospital [9] 0 0
Research Site - Garran
Recruitment hospital [10] 0 0
Research Site - Ipswich
Recruitment hospital [11] 0 0
Research Site - Melbourne
Recruitment hospital [12] 0 0
Research Site - Sherwood
Recruitment hospital [13] 0 0
Research Site - Smithfield
Recruitment hospital [14] 0 0
Research Site - South Lake
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Burwood
Recruitment postcode(s) [3] 0 0
- Castle Hill
Recruitment postcode(s) [4] 0 0
- Coorparoo
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- Corio
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- Cowra
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- Edmonton
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- Forbes
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- Garran
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- Ipswich
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- Melbourne
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- Sherwood
Recruitment postcode(s) [13] 0 0
- Smithfield
Recruitment postcode(s) [14] 0 0
- South Lake
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT02322762
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jesus Medina, PhD
Address 0 0
AstraZeneca
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02322762