ClinicalTrials.gg
CompletedNCT02322762DISCOVERUpdated Jun 9, 2022

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

An observational study in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 308 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,992
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 diabetes mellitus
  • Anti-diabetic management patterns
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 15,992 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes mellitus initiating their second line anti-diabetic therapy after first line anti-diabetic therapy. Participating investigators will belong to primary, secondary or tertiary care clinics or hospitals in proportions trying to resemble the reality of management of this type of patients in each country.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of subject
  2. Female or male aged 18 years and over
  3. Diagnosed with type 2 diabetes mellitus
  4. Initiating a anti-diabetic therapy, either as add-on, or switching from one monotherapy to another.

Exclusion criteria

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
  5. Patient is on dialysis or has had a renal transplant
  6. The patient is taking insulin as 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 .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,992 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 3 Years

Secondary outcomes

  1. Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.

    Time frame: Up to 3 years

  2. Changes in anti-diabetic treatments

    Time frame: Up to 3 years

  3. Disease progression (incidence of microvascular and macrovascular complications).

    Time frame: Up to 3 years

  4. Incidence of hypoglycemic events.

    Time frame: Up to 3 years

  5. Quality of Life, using Patient Reported Outcomes questionnaires.

    Time frame: Up to 3 years

  6. Use of Healthcare resources.

    Time frame: Up to 3 years

07

Study locations

308 sites
  • Research Site
    Alger, Algeria
  • Research Site
    Algiers, Algeria
  • Research Site
    Batna, Algeria
  • Research Site
    Blida, Algeria
  • Research Site
    Constantine, Algeria
  • Research Site
    Oran, Algeria
  • Research Site
    Setif, Algeria
  • Research Site
    Chacabuco, Argentina
  • Research Site
    Ciudad Autonoma Buenos Aires, Argentina
  • Research Site
    Ciudad Autonoma de Buenos Aires, Argentina
  • Research Site
    Cordoba, Argentina
  • Research Site
    Corrientes, Argentina
  • Research Site
    Parana, Argentina
  • Research Site
    Rosario, Argentina
  • Research Site
    San Miguel de Tucuman, Argentina
  • Research Site
    Santa Fe, Argentina
  • Research Site
    Blacktown, Australia
  • Research Site
    Burwood, Australia
  • Research Site
    Castle Hill, Australia
  • Research Site
    Coorparoo, Australia
  • Research Site
    Corio, Australia
  • Research Site
    Cowra, Australia
  • Research Site
    Edmonton, Australia
  • Research Site
    Forbes, Australia
  • Research Site
    Garran, Australia
  • Research Site
    Ipswich, Australia
  • Research Site
    Melbourne, Australia
  • Research Site
    Sherwood, Australia
  • Research Site
    Smithfield, Australia
  • Research Site
    South Lake, Australia
  • Research Site
    Feldbach, Austria
  • Research Site
    Graz, Austria
  • Research Site
    Innsbruck, Austria
  • Research Site
    Linz, Austria
  • Research Site
    Salzburg, Austria
  • Research Site
    St.Veit im Pongau, Austria
  • Research Site
    Stankt Stefan Ob Stainz, Austria
  • Research Site
    Vienna, Austria
  • Research Site
    Wien, Austria
  • Research Site
    Bahrain, Bahrain
  • Research Site
    Belo Horizonte, Brazil
  • Research Site
    Brasilia, Brazil
  • Research Site
    Campina Grande do Sul, Brazil
  • Research Site
    Campinas, Brazil
  • Research Site
    Curitiba, Brazil
  • Research Site
    Fortaleza, Brazil
  • Research Site
    Juiz de Fora, Brazil
  • Research Site
    Porto Alegre, Brazil
  • Research Site
    Rio de Janeiro, Brazil
  • Research Site
    Santa Maria, Brazil
  • Research Site
    Sao Jose do Rio Preto, Brazil
  • Research Site
    Sao Jose dos Campos, Brazil
  • Research Site
    Sao Paulo, Brazil
  • Research Site
    Beijing, China
  • Research Site
    Changsha, China
  • Research Site
    Chengdu, China
  • Research Site
    Chenzhou, China
  • Research Site
    Chongqing, China
  • Research Site
    Fuzhou, China
  • Research Site
    Guangzhou, China
  • Research Site
    Guiyang, China
  • Research Site
    Hefei, China
  • Research Site
    Kunming, China
  • Research Site
    Lanzhou, China
  • Research Site
    Nanjing, China
  • Research Site
    Panjin, China
  • Research Site
    Shanghai, China
  • Research Site
    Shantou, China
  • Research Site
    Shijiazhuang, China
  • Research Site
    Shiyan, China
  • Research Site
    Suzhou City, China
  • Research Site
    Tianjin, China
  • Research Site
    Urumchi, China
  • Research Site
    Wuhan, China
  • Research Site
    Wuxi, China
  • Research Site
    Barranquilla, Colombia
  • Research Site
    Bogota, Colombia
  • Research Site
    Cali, Colombia
  • Research Site
    Manizales, Colombia
  • Research Site
    Medellin, Colombia
  • Research Site
    Cartago, Costa Rica
  • Research Site
    Heredia, Costa Rica
  • Research Site
    San Jose, Costa Rica
  • Research Site
    Benatky nad Jizerou, Czechia
  • Research Site
    Beroun, Czechia
  • Research Site
    Broumov, Czechia
  • Research Site
    Dolni Brezany, Czechia
  • Research Site
    Karlovy Vary, Czechia
  • Research Site
    Krnov, Czechia
  • Research Site
    Litomerice, Czechia
  • Research Site
    Nachod, Czechia
  • Research Site
    Olomouc, Czechia
  • Research Site
    Ostrava, Czechia
  • Research Site
    Plzen, Czechia
  • Research Site
    Praha, Czechia
  • Research Site
    Uherske Hradiste, Czechia
  • Research Site
    Ujezd U Brna, Czechia
  • Research Site
    Alexandria, Egypt
  • Research Site
    Asyut, Egypt
  • Research Site
    Cairo, Egypt

Showing the first 100 of 308 sites across 32 countries. Choose a country and city above to see the rest.

08

References and documents

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. PubMed 36342972 ↗
  • 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. PubMed 35857060 ↗
  • 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. PubMed 35546275 ↗
  • 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. PubMed 32868349 ↗
  • 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. PubMed 32003099 ↗
  • 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. PubMed 31468637 ↗
  • 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. PubMed 31297947 ↗
  • 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. PubMed 31215715 ↗
  • 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. PubMed 30486889 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2014 to primary completion in Aug 2019, 55 months.

Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 55 months is above that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2014
First posted
Dec 23, 2014
StartActual
Dec 30, 2014
Primary completionActual
Aug 21, 2019
CompletionActual
Aug 21, 2019
Last update
Jun 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02322762
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Dec 30, 2014
Primary completion
Aug 21, 2019
Completion
Aug 21, 2019
Last update
Jun 9, 2022

Study contacts

Jesus Medina, PhD
study director · AstraZeneca
Linong Ji, MD
principal investigator · Peking University People's Hospital, China
Bong Soo Cha, Dr.
principal investigator · Severance Hospital, Yonsei University Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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