Type 2 Diabetes Mellitus Clinical Trial
— DISCOVEROfficial title:
DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
| Verified date | June 2022 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 15992 |
| Est. completion date | August 21, 2019 |
| Est. primary completion date | August 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Algeria | 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 | |
| Argentina | 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 | |
| Australia | 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 | |
| Austria | 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 | |
| Bahrain | Research Site | Bahrain | |
| Brazil | 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 | |
| China | 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 | |
| Colombia | Research Site | Barranquilla | |
| Colombia | Research Site | Bogota | |
| Colombia | Research Site | Cali | |
| Colombia | Research Site | Manizales | |
| Colombia | Research Site | Medellin | |
| Costa Rica | Research Site | Cartago | |
| Costa Rica | Research Site | Heredia | |
| Costa Rica | Research Site | San Jose | |
| Czechia | 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 | |
| Egypt | Research Site | Alexandria | |
| Egypt | Research Site | Asyut | |
| Egypt | Research Site | Cairo | |
| Egypt | Research Site | Giza | |
| Egypt | Research Site | Heliopolis | |
| Egypt | Research Site | Mansoura | |
| Egypt | Research Site | Minya | |
| Egypt | Research Site | Tanta | |
| India | Research Site | Bangalore | |
| India | Research Site | Chandigarh | |
| India | Research Site | Chennai | |
| India | Research Site | Coimbatore | |
| India | Research Site | Delhi | |
| India | Research Site | Ghaziabad | |
| India | Research Site | Gurgaon | |
| India | Research Site | Hyderabad | |
| India | Research Site | Indore | |
| India | Research Site | Jaipur | |
| India | Research Site | Kanpur | |
| India | Research Site | Karnal | |
| India | Research Site | Kolkata | |
| India | Research Site | Mangalore | |
| India | Research Site | Mumbai | |
| India | Research Site | Nagpur | |
| India | Research Site | Noida | |
| India | Research Site | Pune | |
| India | Research Site | Trivandrum | |
| Indonesia | Research Site | Balikpapan | |
| Indonesia | Research Site | Banda Aceh | |
| Indonesia | Research Site | Batu | |
| Indonesia | Research Site | Bekasi Timur | |
| Indonesia | Research Site | Denpasar | |
| Indonesia | Research Site | Jakarta | |
| Indonesia | Research Site | Malang | |
| Indonesia | Research Site | Manado | |
| Indonesia | Research Site | Padang | |
| Italy | Research Site | Foggia | |
| Italy | Research Site | Garbagnate Milanese | |
| Italy | Research Site | Livorno | |
| Italy | Research Site | Mariano Comense | |
| Italy | Research Site | Parma | |
| Italy | Research Site | Pavia | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Potenza | |
| Italy | Research Site | Rimini | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Sesto San Giovanni | |
| Jordan | Research Site | Amman | |
| Jordan | Research Site | Az Zarqaa | |
| Jordan | Research Site | Irbid | |
| Korea, Republic of | Research Site | Bucheon-si | |
| Korea, Republic of | Research Site | Cheonan-si | |
| Korea, Republic of | Research Site | Chuncheon-si | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Gwangmyeong Si | |
| Korea, Republic of | Research Site | Iksan | |
| Korea, Republic of | Research Site | Jeju Special Self-Governing Province | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Kuwait | Research Site | Kuwait City | |
| Lebanon | Research Site | Beirut | |
| Lebanon | Research Site | Chtoura | |
| Lebanon | Research Site | Hamra | |
| Lebanon | Research Site | Jbeil | |
| Lebanon | Research Site | Mazraat Yachouh | |
| Lebanon | Research Site | Saida | |
| Lebanon | Research Site | Tripoli | |
| Lebanon | Research Site | Tyre | |
| Malaysia | Research Site | Air Itam | |
| Malaysia | Research Site | Alor Setar | |
| Malaysia | Research Site | Ipoh | |
| Malaysia | Research Site | Johor Bahru | |
| Malaysia | Research Site | Kelantan | |
| Malaysia | Research Site | Kuala Krai | |
| Malaysia | Research Site | Masjid Tanah | |
| Malaysia | Research Site | Miri | |
| Malaysia | Research Site | Perak | |
| Malaysia | Research Site | Sandakan | |
| Malaysia | Research Site | Seremban | |
| Mexico | Research Site | Acapulco de Juarez | |
| Mexico | Research Site | Aguascalientes | |
| Mexico | Research Site | Chihuahua | |
| Mexico | Research Site | Guadalajara | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Monterrey | |
| Mexico | Research Site | San Juan del Rio | |
| Mexico | Research Site | Tamaulipas | |
| Mexico | Research Site | Zapopan | |
| Netherlands | Research Site | Almelo | |
| Netherlands | Research Site | Alpen Aan Den Rijn | |
| Netherlands | Research Site | Amersfoort | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | De Bilt | |
| Netherlands | Research Site | Den Haag | |
| Netherlands | Research Site | Doetinchem | |
| Netherlands | Research Site | Dordrecht | |
| Netherlands | Research Site | Dorst | |
| Netherlands | Research Site | Elst | |
| Netherlands | Research Site | Enschede | |
| Netherlands | Research Site | Etten-Leur | |
| Netherlands | Research Site | Garderen | |
| Netherlands | Research Site | Geleen | |
| Netherlands | Research Site | Gouda | |
| Netherlands | Research Site | Hoogezand | |
| Netherlands | Research Site | Katwijk | |
| Netherlands | Research Site | Kerkrade | |
| Netherlands | Research Site | Kloosterhaar | |
| Netherlands | Research Site | Landgraaf | |
| Netherlands | Research Site | Luttenberg | |
| Netherlands | Research Site | Nijverdal | |
| Netherlands | Research Site | Oisterwijk | |
| Netherlands | Research Site | Roermond | |
| Netherlands | Research Site | Soerendonk | |
| Netherlands | Research Site | Steenbergen | |
| Netherlands | Research Site | Utrecht | |
| Netherlands | Research Site | Vaassen | |
| Netherlands | Research Site | Voerendaal | |
| Netherlands | Research Site | Wamel | |
| Netherlands | Research Site | Zoetermeer | |
| Netherlands | Research Site | Zundert | |
| Oman | Research Site | Muscat | |
| Panama | Research Site | Calle | |
| Panama | Research Site | Cocle | |
| Poland | Research Site | Chorzow | |
| Poland | Research Site | Elblag | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Parczew | |
| Poland | Research Site | Rzeszow | |
| Poland | Research Site | Zabrze | |
| Poland | Research Site | Zgierz | |
| Russian Federation | Research Site | Arkhangelsk | |
| Russian Federation | Research Site | Barnaul | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Rostov-on-Don | |
| Russian Federation | Research Site | Sankt Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | Sestroretsk | |
| Russian Federation | Research Site | Stavropol | |
| Russian Federation | Research Site | Yaroslavl | |
| Saudi Arabia | Research Site | Abha | |
| Saudi Arabia | Research Site | Al Jouf | |
| Saudi Arabia | Research Site | Jeddah | |
| Saudi Arabia | Research Site | Khamis Mushayt | |
| Saudi Arabia | Research Site | Riyadh | |
| South Africa | Research Site | Alberton | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Johannesburg | |
| South Africa | Research Site | Lenasia | |
| South Africa | Research Site | Merebank | |
| South Africa | Research Site | Midstream | |
| South Africa | Research Site | Moloto | |
| South Africa | Research Site | Port Elizabeth | |
| South Africa | Research Site | Pretoria | |
| South Africa | Research Site | Umkomaas | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Cadiz | |
| Spain | Research Site | Elche | |
| Spain | Research Site | Espinardo | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Mostoles | |
| Spain | Research Site | Salamanca | |
| Spain | Research Site | Sanlucar de Barrameda | |
| Spain | Research Site | Segovia | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Valencia | |
| Taiwan | Research Site | Changhua | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | New Taipei City | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung City | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan City | |
| Taiwan | Research Site | Taipei | |
| Tunisia | Research Site | Gabes | |
| Tunisia | Research Site | Kairaouane | |
| Tunisia | Research Site | La Soukra | |
| Tunisia | Research Site | Mahdia | |
| Tunisia | Research Site | Mont Fleury | |
| Tunisia | Research Site | Montfleury | |
| Tunisia | Research Site | Mutuelleville | |
| Tunisia | Research Site | Nabeul | |
| Tunisia | Research Site | Sfax | |
| Tunisia | Research Site | Sousse | |
| Tunisia | Research Site | Tunis | |
| Tunisia | Research Site | Tunis Belvedere | |
| Turkey | Research Site | Adana | |
| Turkey | Research Site | Afyonkarahisar | |
| Turkey | Research Site | Antalya | |
| Turkey | Research Site | Canakkale | |
| Turkey | Research Site | Corum | |
| Turkey | Research Site | Denizli | |
| Turkey | Research Site | Diyarbakir | |
| Turkey | Research Site | Duzce | |
| Turkey | Research Site | Elazig | |
| Turkey | Research Site | Gaziantep | |
| Turkey | Research Site | Hatay | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Karaman | |
| Turkey | Research Site | Kayseri | |
| Turkey | Research Site | Samsun | |
| United Arab Emirates | Research Site | Abu Dhabi | |
| United Arab Emirates | Research Site | Dubai |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Algeria, Argentina, Australia, Austria, Bahrain, Brazil, China, Colombia, Costa Rica, Czechia, Egypt, India, Indonesia, Italy, Jordan, Korea, Republic of, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Oman, Panama, Poland, Russian Federation, Saudi Arabia, South Africa, Spain, Taiwan, Tunisia, Turkey, United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 3 Years | |
| Secondary | Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure. | Up to 3 years | ||
| Secondary | Changes in anti-diabetic treatments | Up to 3 years | ||
| Secondary | Disease progression (incidence of microvascular and macrovascular complications). | Up to 3 years | ||
| Secondary | Incidence of hypoglycemic events. | Up to 3 years | ||
| Secondary | Quality of Life, using Patient Reported Outcomes questionnaires. | Up to 3 years | ||
| Secondary | Use of Healthcare resources. | Up to 3 years |
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