DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

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.

• Study Type: Observational
• Enrollment (Actual): 15992

Contacts and Locations

Study Locations

• Algeria
  • 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
• Argentina
  • 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
• Australia
  • Blacktown, Australia
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  • Burwood, Australia
    • Research Site
  • Castle Hill, Australia
    • Research Site
  • Coorparoo, Australia
    • Research Site
  • Corio, Australia
    • Research Site
  • Cowra, Australia
    • Research Site
  • Edmonton, Australia
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  • Forbes, Australia
    • Research Site
  • Garran, Australia
    • Research Site
  • Ipswich, Australia
    • Research Site
  • Melbourne, Australia
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  • Sherwood, Australia
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  • Smithfield, Australia
    • Research Site
  • South Lake, Australia
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• Austria
  • Feldbach, Austria
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  • Graz, Austria
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  • Innsbruck, Austria
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  • Linz, Austria
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  • Salzburg, Austria
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  • St.Veit im Pongau, Austria
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  • Stankt Stefan Ob Stainz, Austria
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  • Vienna, Austria
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  • Wien, Austria
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• Bahrain
  • Bahrain, Bahrain
    • Research Site
• Brazil
  • Belo Horizonte, Brazil
    • Research Site
  • Brasilia, Brazil
    • Research Site
  • Campina Grande do Sul, Brazil
    • Research Site
  • Campinas, Brazil
    • Research Site
  • Curitiba, Brazil
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  • Fortaleza, Brazil
    • Research Site
  • Juiz de Fora, Brazil
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  • Porto Alegre, Brazil
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  • Rio de Janeiro, Brazil
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  • Santa Maria, Brazil
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  • Sao Jose do Rio Preto, Brazil
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  • Sao Jose dos Campos, Brazil
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  • Sao Paulo, Brazil
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• China
  • Beijing, China
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  • Changsha, China
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  • Chengdu, China
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  • Chenzhou, China
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  • Chongqing, China
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  • Fuzhou, China
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  • Guangzhou, China
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  • Guiyang, China
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  • Hefei, China
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  • Kunming, China
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  • Lanzhou, China
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  • Nanjing, China
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  • Panjin, China
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  • Shanghai, China
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  • Shantou, China
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  • Shijiazhuang, China
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  • Shiyan, China
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  • Suzhou City, China
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  • Tianjin, China
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  • Urumchi, China
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  • Wuhan, China
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  • Wuxi, China
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• Colombia
  • Barranquilla, Colombia
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  • Bogota, Colombia
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  • Cali, Colombia
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  • Manizales, Colombia
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  • Medellin, Colombia
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• Costa Rica
  • Cartago, Costa Rica
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  • Heredia, Costa Rica
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  • San Jose, Costa Rica
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• Czechia
  • Benatky nad Jizerou, Czechia
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  • Beroun, Czechia
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  • Broumov, Czechia
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  • Dolni Brezany, Czechia
    • Research Site
  • Karlovy Vary, Czechia
    • Research Site
  • Krnov, Czechia
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  • Litomerice, Czechia
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  • Nachod, Czechia
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  • Olomouc, Czechia
    • Research Site
  • Ostrava, Czechia
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  • Plzen, Czechia
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  • Praha, Czechia
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  • Uherske Hradiste, Czechia
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  • Ujezd U Brna, Czechia
    • Research Site
• Egypt
  • Alexandria, Egypt
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  • Asyut, Egypt
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  • Cairo, Egypt
    • Research Site
  • Giza, Egypt
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  • Heliopolis, Egypt
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  • Mansoura, Egypt
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  • Minya, Egypt
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  • Tanta, Egypt
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• India
  • Bangalore, India
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  • Chandigarh, India
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  • Chennai, India
    • Research Site
  • Coimbatore, India
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  • Delhi, India
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  • Ghaziabad, India
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  • Gurgaon, India
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  • Hyderabad, India
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  • Indore, India
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  • Jaipur, India
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  • Kanpur, India
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  • Karnal, India
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  • Kolkata, India
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  • Mangalore, India
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  • Mumbai, India
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  • Nagpur, India
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  • Noida, India
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  • Pune, India
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  • Trivandrum, India
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• Indonesia
  • Balikpapan, Indonesia
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  • Banda Aceh, Indonesia
    • Research Site
  • Batu, Indonesia
    • Research Site
  • Bekasi Timur, Indonesia
    • Research Site
  • Denpasar, Indonesia
    • Research Site
  • Jakarta, Indonesia
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  • Malang, Indonesia
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  • Manado, Indonesia
    • Research Site
  • Padang, Indonesia
    • Research Site
• Italy
  • Foggia, Italy
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  • Garbagnate Milanese, Italy
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  • Livorno, Italy
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  • Mariano Comense, Italy
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  • Parma, Italy
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  • Pavia, Italy
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  • Pisa, Italy
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  • Potenza, Italy
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  • Rimini, Italy
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  • Roma, Italy
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  • Sesto San Giovanni, Italy
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• Jordan
  • Amman, Jordan
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  • Az Zarqaa, Jordan
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  • Irbid, Jordan
    • Research Site
• Korea, Republic of
  • 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, Korea, Republic of
    • Research Site
• Kuwait
  • Kuwait City, Kuwait
    • Research Site
• Lebanon
  • 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
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  • Tyre, Lebanon
    • Research Site
• Malaysia
  • Air Itam, Malaysia
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  • Alor Setar, Malaysia
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  • Ipoh, Malaysia
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  • Johor Bahru, Malaysia
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  • Kelantan, Malaysia
    • Research Site
  • Kuala Krai, Malaysia
    • Research Site
  • Masjid Tanah, Malaysia
    • Research Site
  • Miri, Malaysia
    • Research Site
  • Perak, Malaysia
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  • Sandakan, Malaysia
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  • Seremban, Malaysia
    • Research Site
• Mexico
  • Acapulco de Juarez, Mexico
    • Research Site
  • Aguascalientes, Mexico
    • Research Site
  • Chihuahua, Mexico
    • Research Site
  • Guadalajara, Mexico
    • Research Site
  • Mexico, Mexico
    • Research Site
  • Monterrey, Mexico
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  • San Juan del Rio, Mexico
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  • Tamaulipas, Mexico
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  • Zapopan, Mexico
    • Research Site
• Netherlands
  • Almelo, Netherlands
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  • Alpen Aan Den Rijn, Netherlands
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  • Amersfoort, Netherlands
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  • Amsterdam, Netherlands
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  • 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
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  • Garderen, Netherlands
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  • Geleen, Netherlands
    • Research Site
  • Gouda, Netherlands
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  • Hoogezand, Netherlands
    • Research Site
  • Katwijk, Netherlands
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  • Kerkrade, Netherlands
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  • Kloosterhaar, Netherlands
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  • Landgraaf, Netherlands
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  • Luttenberg, Netherlands
    • Research Site
  • Nijverdal, Netherlands
    • Research Site
  • Oisterwijk, Netherlands
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  • Roermond, Netherlands
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  • Soerendonk, Netherlands
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  • Steenbergen, Netherlands
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  • Utrecht, Netherlands
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  • Vaassen, Netherlands
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  • Voerendaal, Netherlands
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  • Wamel, Netherlands
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  • Zoetermeer, Netherlands
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  • Zundert, Netherlands
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• Oman
  • Muscat, Oman
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• Panama
  • Calle, Panama
    • Research Site
  • Cocle, Panama
    • Research Site
• Poland
  • Chorzow, Poland
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  • Elblag, Poland
    • Research Site
  • Gdansk, Poland
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  • Katowice, Poland
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  • Krakow, Poland
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  • Lodz, Poland
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  • Lublin, Poland
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  • Parczew, Poland
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  • Rzeszow, Poland
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  • Zabrze, Poland
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  • Zgierz, Poland
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• Russian Federation
  • Arkhangelsk, Russian Federation
    • Research Site
  • Barnaul, Russian Federation
    • Research Site
  • Moscow, Russian Federation
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  • Nizhniy Novgorod, Russian Federation
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  • 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
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  • Stavropol, Russian Federation
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  • Yaroslavl, Russian Federation
    • Research Site
• Saudi Arabia
  • Abha, Saudi Arabia
    • Research Site
  • Al Jouf, Saudi Arabia
    • Research Site
  • Jeddah, Saudi Arabia
    • Research Site
  • Khamis Mushayt, Saudi Arabia
    • Research Site
  • Riyadh, Saudi Arabia
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• South Africa
  • Alberton, South Africa
    • Research Site
  • Cape Town, South Africa
    • Research Site
  • Durban, South Africa
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  • Johannesburg, South Africa
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  • Lenasia, South Africa
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  • Merebank, South Africa
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  • Midstream, South Africa
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  • Moloto, South Africa
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  • Port Elizabeth, South Africa
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  • Pretoria, South Africa
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  • Umkomaas, South Africa
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• Spain
  • Barcelona, Spain
    • Research Site
  • Cadiz, Spain
    • Research Site
  • Elche, Spain
    • Research Site
  • Espinardo, Spain
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  • Madrid, Spain
    • Research Site
  • Mostoles, Spain
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  • Salamanca, Spain
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  • Sanlucar de Barrameda, Spain
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  • Segovia, Spain
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  • Sevilla, Spain
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  • Valencia, Spain
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• Taiwan
  • Changhua, Taiwan
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  • Kaohsiung, Taiwan
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  • 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, Taiwan
    • Research Site
• Tunisia
  • Gabes, Tunisia
    • Research Site
  • Kairaouane, Tunisia
    • Research Site
  • La Soukra, Tunisia
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  • Mahdia, Tunisia
    • Research Site
  • Mont Fleury, Tunisia
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  • Montfleury, Tunisia
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  • Mutuelleville, Tunisia
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  • Nabeul, Tunisia
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  • Sfax, Tunisia
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  • Sousse, Tunisia
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  • Tunis, Tunisia
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  • Tunis Belvedere, Tunisia
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• Turkey
  • Adana, Turkey
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  • Afyonkarahisar, Turkey
    • Research Site
  • Antalya, Turkey
    • Research Site
  • Canakkale, Turkey
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  • Corum, Turkey
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  • Denizli, Turkey
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  • Diyarbakir, Turkey
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  • Duzce, Turkey
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  • Elazig, Turkey
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  • Gaziantep, Turkey
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  • Hatay, Turkey
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  • Istanbul, Turkey
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  • Izmir, Turkey
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  • Karaman, Turkey
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  • Kayseri, Turkey
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  • Samsun, Turkey
    • Research Site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Research Site
  • Dubai, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.	Up to 3 years
Changes in anti-diabetic treatments	Up to 3 years
Disease progression (incidence of microvascular and macrovascular complications).	Up to 3 years
Incidence of hypoglycemic events.	Up to 3 years
Quality of Life, using Patient Reported Outcomes questionnaires.	Up to 3 years
Use of Healthcare resources.	Up to 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Jesús Medina, PhD, AstraZeneca; Principal Investigator: Linong Ji, MD, Peking University People's Hospital, China; Principal Investigator: Bong Soo Cha, Dr., Severance Hospital, Yonsei University Health System

Publications and helpful links

General 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. 2022 Nov 28:1-9. doi: 10.1080/03007995.2022.2144052. Online ahead of print.
• 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.

Helpful Links

• redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2014
• Primary Completion (Actual): August 21, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Anti-diabetic management patterns
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1690R00002