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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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- Burwood
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- Castle Hill
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- 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
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- Smithfield
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- South Lake
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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/study/NCT02322762
Trial related presentations / publications
Al-Rubeaan K, Banah F, Alruwaily FG, Sheshah E, Alnaqeb D, AlQahtani AM, Ewais D, Al Juhani N, Hassan AH, Youssef AM. Longitudinal assessment of the quality of life and patterns of antidiabetic medication use in patients with type 2 diabetes, Saudi Arabia perspective, DISCOVER study. Curr Med Res Opin. 2023 Jan;39(1):27-35. doi: 10.1080/03007995.2022.2144052. Epub 2022 Nov 28.
Mita T, Katakami N, Takahara M, Kawashima M, Wada F, Akiyama H, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H. Changes in Treatment Satisfaction Over 3 Years in Patients With Type 2 Diabetes After Initiating Second-line Treatment. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2424-2432. doi: 10.1210/clinem/dgac420.
Hejjaji V, Gorgojo-Martinez JJ, Tang F, Garnelo JB, Cooper A, Medina J, Mutiozabal MS, Khunti K, Nicolucci A, Shestakova MV, Ji L, Gomes MB, Watada H, Vora J, Malik AO, Kosiborod M, Arnold SV. Factors associated with weight loss in people with overweight or obesity living with type 2 diabetes mellitus: Insights from the global DISCOVER study. Diabetes Obes Metab. 2022 Sep;24(9):1734-1740. doi: 10.1111/dom.14745. Epub 2022 May 25.
Khunti K, Gomes MB, Kosiborod M, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Tang F, Ji L; DISCOVER Scientific Committee and all DISCOVER investigators. Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme. BMJ Open. 2020 Aug 30;10(8):e034613. doi: 10.1136/bmjopen-2019-034613.
Wang JS, Chen H, Tang F, Sheu WH. Associations of fear of hypoglycemia with second-line use of insulin secretagogues or insulin and subsequent glycemic control in patients with type 2 diabetes: An analysis using data from the DISCOVER study. Int J Clin Pract. 2020 Jun;74(6):e13485. doi: 10.1111/ijcp.13485. Epub 2020 Feb 11.
Khunti K, Chen H, Cid-Ruzafa J, Fenici P, Gomes MB, Hammar N, Ji L, Kosiborod M, Pocock S, Shestakova MV, Shimomura I, Tang F, Watada H, Nicolucci A; DISCOVER investigators. Glycaemic control in patients with type 2 diabetes initiating second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2020 Jan;22(1):66-78. doi: 10.1111/dom.13866. Epub 2019 Oct 1.
Nicolucci A, Charbonnel B, Gomes MB, Khunti K, Kosiborod M, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Pocock S. Treatment patterns and associated factors in 14 668 people with type 2 diabetes initiating a second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2474-2485. doi: 10.1111/dom.13830. Epub 2019 Aug 5.
Khunti K, Ji L, Medina J, Surmont F, Kosiborod M. Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2349-2353. doi: 10.1111/dom.13817. Epub 2019 Jul 14.
Kosiborod M, Gomes MB, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Watada H, Shimomura I, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Khunti K; DISCOVER investigators. Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program). Cardiovasc Diabetol. 2018 Nov 28;17(1):150. doi: 10.1186/s12933-018-0787-8.
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/study/NCT02322762