THE DISCOVER STUDY

View Countries
16707 Enrolled Patients

  • North America
    • Canada
  • Latin America
    • Argentina
    • Brazil
    • Colombia
    • Costa Rica
    • Mexico
    • Panama
  • Europe
    • Austria
    • Czech Republic
    • Denmark
    • France
    • Italy
    • Netherlands
    • Norway
    • Poland
    • Russia
    • Spain
    • Sweden
  • Africa
    • Algeria
    • Egypt
    • South Africa
    • Tunisia
  • Middle East
    • Bahrain
    • Jordan
    • Kuwait
    • Lebanon
    • Oman
    • Saudi Arabia
    • Turkey
    • United Arab Emirates
  • Asia Pacific
    • Australia
    • China
    • India
    • Indonesia
    • Japan
    • Malaysia
    • South Korea
    • Taiwan

Country

  • Planned number of sites: xx
  • Planned number of patients: xx
  • Recruiting sites(as of xx)
  • Recruited patients(as of xx)
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Bahrain,2,41,21/06/2016,2,21/06/2016,70
Jordan,20,260,21/06/2016,17,21/06/2016,277
Kuwait,1,20,21/06/2016,1,21/06/2016,51
Lebanon,10,550,21/06/2016,10,21/06/2016,371
Oman,1,20,21/06/2016,1,21/06/2016,31
Saudi Arabia,10,550,21/06/2016,15,21/06/2016,585
Turkey,20,500,21/06/2016,19,21/06/2016,536
United Arab Emirates,16,160,21/06/2016,8,21/06/2016,102
Algeria,15,300,21/06/2016,14,21/06/2016,299
Egypt,1,20,21/06/2016,1,21/06/2016,585
South Africa,50,600,21/06/2016,50,21/06/2016,521
Tunisia,20,260,21/06/2016,20,21/06/2016,218
Argentina,13,320,21/06/2016,14,21/06/2016,302
Brazil,24,460,21/06/2016,24,21/06/2016,444
Colombia,10,200,21/06/2016,10,21/06/2016,211
Costa Rica,6,150,21/06/2016,6,21/06/2016,128
Mexico,17,500,21/06/2016,16,21/06/2016,473
Panama,3,50,21/06/2016,3,21/06/2016,92
Canada,35,423,21/06/2016,35,21/06/2016,376
Australia,12,200,21/06/2016,14,21/06/2016,176
China,34,1480,21/06/2016,31,21/06/2016,1298
India,32,2410,21/06/2016,29,21/06/2016,3150
Indonesia,15,210,21/06/2016,14,21/06/2016,237
Japan,170,1800,22/01/2016,135,22/01/2016,1916
Malaysia,12,250,21/06/2016,14,21/06/2016,342
South Korea,16,220,21/06/2016,13,21/06/2016,250
Taiwan,15,220,21/06/2016,14,21/06/2016,265
Austria,10,200,21/06/2016,12,21/06/2016,209
Czech Republic,15,450,21/06/2016,17,21/06/2016,461
Denmark,20,100,21/06/2016,12,21/06/2016,41
France,200,250,21/06/2016,192,21/06/2016,267
Italy,11,310,21/06/2016,11,21/06/2016,378
Netherlands,10,200,21/06/2016,56,21/06/2016,172
Norway,20,100,21/06/2016,22,21/06/2016,71
Poland,13,270,21/06/2016,14,21/06/2016,328
Russia,15,500,21/06/2016,17,21/06/2016,601
Spain,10,200,21/06/2016,14,21/06/2016,233
Sweden,40,300,21/06/2016,36,21/06/2016,233
DISCOVER study design

DISCOVER recruitment status last updated June 2016.

Rationale

Type 2 diabetes is widespread and its prevalence is increasing rapidly worldwide. In many countries, information on treatment patterns and clinical outcomes remain scarce or incomplete, and few data have been captured and published on newer classes of type 2 diabetes therapies, such as DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors.

Aim

The aim of the DISCOVER study is to describe the patient characteristics, evolution of disease management patterns and clinical outcomes over 3 years in individuals with type 2 diabetes mellitus who are initiating a second-line anti-diabetic therapy in real world settings.

Design

DISCOVER is a global, prospective, non-interventional study conducted in 38 countries across six continents. The study has enrolled about 15 000 patients, who will be followed up for 3 years.

Data are collected during routine visits from three different sources:

  1. electronic medical records, when available
  2. electronic case report forms (eCRFs), which include additional patient clinical data provided by the investigator
  3. patient-reported outcomes questionnaires completed by patients.

Data are collected at five time points and anonymized before being sent to a central database for analysis.

DISCOVER study design

Participating centres and patient entry criteria

Clinical practices and hospitals have been selected to represent type 2 diabetes management in each participating country. Patients from these centres were enrolled into the DISCOVER study based on the following inclusion and exclusion criteria.

Inclusion criteria
  • Type 2 diabetes mellitus
  • Aged 18 years or older
  • Initiating second-line therapy (add-on or switching) after first-line oral treatment with a monotherapy, or dual or triple therapy
  • Informed consent
Exclusion criteria
  • Type 1 diabetes
  • Pregnancy
  • Current treatment with chemotherapy, or oral or intravenous steroids
  • Undergoing dialysis or has received a renal transplant
  • Taking insulin or an injectable agent as first-line treatment
  • Initiating dual therapy after previously taking two different lines of monotherapy
  • Using herbal remedies/natural medicines on their own as first-line treatment
  • Participating in an interventional trial
  • Presence of any condition or circumstance that, in the opinion of the investigator, could significantly curtail the planned 3-year follow-up (e.g. a life-threatening comorbidity, tourist status, a non-native speaker or a poor understanding of the local language in places where interpreter services are not reliably available, a psychiatric disturbance, dementia, or alcohol or drug abuse)
  • Unwillingness to provide informed consent

Outcome measures

Primary outcome measure
  • The classes of drugs or their combinations prescribed by physicians to patients starting a second-line anti-diabetic treatment and associated clinical evolution (disease control in terms of achieving a target HbA1c level and reducing body weight and blood pressure, and disease progression in terms of occurrence of hypoglycaemic events and microvascular and macrovascular complications)
Secondary outcome measures
  • Site characteristics
  • Physician speciality
  • Patient demographics
  • Vital signs and laboratory test results
  • Medical history of type 2 diabetes, including presence of risk factors
  • Comorbidities and co-medications
  • Change(s) in type 2 diabetes treatments during follow-up and reason(s) for change(s)
  • Number of major hypoglycaemic events and occurrence of minor hypoglycaemic events
  • Microvascular complications (nephropathy, retinopathy, neuropathy and amputation)
  • Macrovascular complications
  • All-cause death
  • Patient-reported outcomes

DISCOVER more

For more information about the DISCOVER study design, please visit the clinical trials registry website set up by the US National Institutes of Health at www.clinicaltrials.gov

NCT02322762: DISCOVERing treatment reality of type 2 diabetes in real world settings (DISCOVER) https://clinicaltrials.gov/ct2/show/NCT02322762

NCT02226822: DISCOVERing treatment reality of type 2 diabetes in real world setting in Japan (J-DISCOVER) https://clinicaltrials.gov/ct2/show/NCT02226822

DISCOVER SCIENTIFIC COMMITTEE

Professor Linong Ji

Professor Linong Ji, MD

Peking University People’s Hospital, Beijing, China

Professor Marília B Gomes

Professor Marília B Gomes, MD, PhD

Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

Professor Antonio Nicolucci

Professor Antonio Nicolucci, MD

Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy

Professor Marina V Shestakova

Professor Marina V Shestakova, MD, PhD

Federal Scientific Centre of Endocrinology, Moscow, Russia

Professor Fabrice Bonnet

Professor Fabrice Bonnet

Rennes University Hospital, Rennes, France

Professor Iichiro Shimomura

Professor Iichiro Shimomura

Graduate School of Medicine, Osaka University, Osaka, Japan

Dr Mikhail Kosiborod

Dr Mikhail Kosiborod, MD

Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, MO, USA

Professor Bernard Charbonnel

Professor Bernard Charbonnel, MD

University of Nantes, Nantes, France

Professor Kamlesh Khunti

Professor Kamlesh Khunti, MBChB, PhD, MD, FRCGP, DCH, DRCOG

University of Leicester, Leicester, UK

Professor Stuart Pocock

Professor Stuart Pocock, MD, PhD

London School of Hygiene & Tropical Medicine, London, UK

Professor Wolfgang Rathmann

Professor Wolfgang Rathmann

German Diabetes Centre Institute for Biometrics and Epidemiology Düsseldorf, Germany

Professor Hirotaka Watada

Professor Hirotaka Watada

Graduate School of Medicine, Juntendo University, Tokyo, Japan

Rationale

Type 2 diabetes is widespread and its prevalence is increasing rapidly worldwide. In many countries, information on treatment patterns and clinical outcomes remain scarce or incomplete, and few data have been captured and published on newer classes of type 2 diabetes therapies, such as DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors.

Aim

The aim of the DISCOVER study is to describe the patient characteristics, evolution of disease management patterns and clinical outcomes over 3 years in individuals with type 2 diabetes mellitus who are initiating a second-line anti-diabetic therapy in real world settings.

Design

DISCOVER is a global, prospective, non-interventional study conducted in 38 countries across six continents. The study has enrolled about 15 000 patients, who will be followed up for 3 years.

Data are collected during routine visits from three different sources:

  1. electronic medical records, when available
  2. electronic case report forms (eCRFs), which include additional patient clinical data provided by the investigator
  3. patient-reported outcomes questionnaires completed by patients.

Data are collected at five time points and anonymized before being sent to a central database for analysis.

DISCOVER study design

Data will be anonymized before being transferred to the Data Analysis Group.

Participating centres and patient entry criteria

Clinical practices and hospitals have been selected to represent type 2 diabetes management in each participating country. Patients from these centres were enrolled into the DISCOVER study based on the following inclusion and exclusion criteria.

Inclusion/exclusion criteria

Inclusion criteria
  • Type 2 diabetes mellitus
  • Aged 18 years or older
  • Initiating second-line therapy (add-on or switching) after first-line oral treatment with a monotherapy, or dual or triple therapy
  • Informed consent
Exclusion criteria
  • Type 1 diabetes
  • Pregnancy
  • Current treatment with chemotherapy, or oral or intravenous steroids
  • Undergoing dialysis or has received a renal transplant
  • Taking insulin or an injectable agent as first-line treatment
  • Initiating dual therapy after previously taking two different lines of monotherapy
  • Using herbal remedies/natural medicines on their own as first-line treatment
  • Participating in an interventional trial
  • Presence of any condition or circumstance that, in the opinion of the investigator, could significantly curtail the planned 3-year follow-up (e.g. a life-threatening comorbidity, tourist status, a non-native speaker or a poor understanding of the local language in places where interpreter services are not reliably available, a psychiatric disturbance, dementia, or alcohol or drug abuse)
  • Unwillingness to provide informed consent

Outcome measures

Primary outcome measure
  • The classes of drugs or their combinations prescribed by physicians to patients starting a second-line anti-diabetic treatment and associated clinical evolution (disease control in terms of achieving a target HbA1c level and reducing body weight and blood pressure, and disease progression in terms of occurrence of hypoglycaemic events and microvascular and macrovascular complications)
Secondary outcome measures
  • Site characteristics
  • Physician speciality
  • Patient demographics
  • Vital signs and laboratory test results
  • Medical history of type 2 diabetes, including presence of risk factors
  • Comorbidities and co-medications
  • Change(s) in type 2 diabetes treatments during follow-up and reason(s) for change(s)
  • Number of major hypoglycaemic events and occurrence of minor hypoglycaemic events
  • Microvascular complications (nephropathy, retinopathy, neuropathy and amputation)
  • Macrovascular complications
  • All-cause death
  • Patient-reported outcomes

DISCOVER more

For more information about the DISCOVER study design, please visit the clinical trials registry website set up by the US National Institutes of Health at www.clinicaltrials.gov

NCT02322762: DISCOVERing treatment reality of type 2 diabetes in real world settings (DISCOVER) https://clinicaltrials.gov/ct2/show/NCT02322762

NCT02226822: DISCOVERing treatment reality of type 2 diabetes in real world setting in Japan (J-DISCOVER) https://clinicaltrials.gov/ct2/show/NCT02226822

DISCOVER Scientific Committee

Professor Linong Ji

Professor Linong Ji, MD

Peking University People’s Hospital, Beijing, China

Professor Marília B Gomes

Professor Marília B Gomes, MD, PhD

Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

Professor Antonio Nicolucci

Professor Antonio Nicolucci, MD

Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy

Professor Marina V Shestakova

Professor Marina V Shestakova, MD, PhD

Federal Scientific Centre of Endocrinology, Moscow, Russia

Professor Fabrice Bonnet

Professor Fabrice Bonnet

Rennes University Hospital, Rennes, France

Professor Iichiro Shimomura

Professor Iichiro Shimomura

Graduate School of Medicine, Osaka University, Osaka, Japan

Dr Mikhail Kosiborod

Dr Mikhail Kosiborod, MD

Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, MO, USA

Professor Bernard Charbonnel

Professor Bernard Charbonnel, MD

University of Nantes, Nantes, France

Professor Kamlesh Khunti

Professor Kamlesh Khunti, MBChB, PhD, MD, FRCGP, DCH, DRCOG

University of Leicester, Leicester, UK

Professor Stuart Pocock

Professor Stuart Pocock, MD, PhD

London School of Hygiene & Tropical Medicine, London, UK

Professor Wolfgang Rathmann

Professor Wolfgang Rathmann

German Diabetes Centre Institute for Biometrics and Epidemiology Düsseldorf, Germany

Professor Hirotaka Watada

Professor Hirotaka Watada

Graduate School of Medicine, Juntendo University, Tokyo, Japan