DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

NCT ID: NCT02322762

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15992 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-30

Study Completion Date

2019-08-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesus Medina, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Linong Ji, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, China

Bong Soo Cha, Dr.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University Health System

Locations

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Research Site

Algiers, , Algeria

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Batna City, , Algeria

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Blida, , Algeria

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Constantine, , Algeria

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Oran, , Algeria

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Sétif, , Algeria

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Buenos Aires, , Argentina

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Chacabuco, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Paraná, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Blacktown, , Australia

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Burwood, , Australia

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Castle Hill, , Australia

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Coorparoo, , Australia

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Corio, , Australia

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Cowra, , Australia

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Edmonton, , Australia

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Forbes, , Australia

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Garran, , Australia

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Ipswich, , Australia

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Melbourne, , Australia

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Sherwood, , Australia

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Smithfield, , Australia

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South Lake, , Australia

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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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Sankt Veit im Pongau, , Austria

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Stankt Stefan Ob Stainz, , Austria

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Vienna, , Austria

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Bahrain, , Bahrain

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Belo Horizonte, , Brazil

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Brasília, , Brazil

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Campina Grande do Sul, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Fortaleza, , Brazil

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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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São José do Rio Preto, , Brazil

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São José dos Campos, , Brazil

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São Paulo, , Brazil

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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, , China

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Tianjin, , China

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Ürümqi, , China

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Wuhan, , China

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Wuxi, , China

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Manizales, , Colombia

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Medellín, , Colombia

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Cartago, , Costa Rica

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Heredia, , Costa Rica

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San José, , Costa Rica

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Benátky nad Jizerou, , Czechia

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Beroun, , Czechia

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Broumov, , Czechia

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Dolní Břežany, , Czechia

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Karlovy Vary, , Czechia

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Krnov, , Czechia

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Litoměřice, , Czechia

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Náchod, , Czechia

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Olomouc, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Uherské Hradiště, , Czechia

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Újezd u Brna, , Czechia

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Al Mansurah, , Egypt

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Alexandria, , Egypt

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Asyut, , Egypt

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Cairo, , Egypt

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Giza, , Egypt

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Heliopolis, , Egypt

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Minya, , Egypt

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Tanta, , Egypt

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Bangalore, , India

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Chandigarh, , India

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Chennai, , India

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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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Karnāl, , 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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Balikpapan, , Indonesia

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Banda Aceh, , Indonesia

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Batu, , Indonesia

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Bekasi Timur, , Indonesia

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Denpasar, , Indonesia

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Jakarta, , Indonesia

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Malang, , Indonesia

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Manado, , Indonesia

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Padang, , Indonesia

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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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Amman, , Jordan

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Az Zarqaa, , Jordan

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Irbid, , Jordan

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Kuwait City, , Kuwait

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Beirut, , Lebanon

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Byblos, , Lebanon

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Chtoura, , Lebanon

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Hamra, , Lebanon

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Mazraat Yachouaa, , Lebanon

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Saida, , Lebanon

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Tripoli, , Lebanon

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Tyre, , Lebanon

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Alor Star, , Malaysia

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Ayer Itam, , Malaysia

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Ipoh, , Malaysia

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Johor Bahru, , Malaysia

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Kelantan, , Malaysia

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Kuala Krai, , Malaysia

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Masjid Tanah, , Malaysia

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Miri, , Malaysia

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Perak, , Malaysia

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Sandakan, , Malaysia

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Seremban, , Malaysia

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Acapulco de Juárez, , Mexico

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Aguascalientes, , Mexico

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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México, , Mexico

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Monterrey, , Mexico

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San Juan del Río, , Mexico

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Tamaulipas, , Mexico

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Zapopan, , Mexico

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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

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Doetinchem, , Netherlands

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Dordrecht, , Netherlands

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Dorst, , Netherlands

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Elst, , Netherlands

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Enschede, , Netherlands

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Etten-Leur, , Netherlands

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Garderen, , Netherlands

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Geleen, , Netherlands

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Gouda, , Netherlands

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Hoogezand, , Netherlands

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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

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Nijverdal, , Netherlands

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Oisterwijk, , Netherlands

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Roermond, , Netherlands

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Soerendonk, , Netherlands

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Steenbergen, , Netherlands

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The Hague, , 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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Muscat, , Oman

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Calle, , Panama

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Coclé, , Panama

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Chorzów, , Poland

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Elblag, , Poland

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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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Rzeszów, , Poland

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Zabrze, , Poland

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Zgierz, , Poland

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Sestroretsk, , Russia

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Stavropol, , Russia

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Yaroslavl, , Russia

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Abhā, , Saudi Arabia

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Al Jouf, , Saudi Arabia

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Jeddah, , Saudi Arabia

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Khamis Mushait, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Alberton, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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eMkhomazi, , 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, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Bucheon-si, , South Korea

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Cheonan-si, , South Korea

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Chuncheon, , South Korea

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Daejeon, , South Korea

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Goyang-si, , South Korea

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Gwangmyeong, , South Korea

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Iksan, , South Korea

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Jeju Special Self-Governing Province, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Cadiz, , Spain

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Elche, , Spain

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Espinardo, , Spain

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Madrid, , Spain

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Móstoles, , Spain

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Salamanca, , Spain

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Sanlúcar de Barrameda, , Spain

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Segovia, , Spain

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Seville, , Spain

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Valencia, , Spain

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Gabès, , Tunisia

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Kairaouane, , Tunisia

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Mahdia, , 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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Sukrah, , Tunisia

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Tunis, , Tunisia

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Tunis Belvedere, , Tunisia

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Adana, , Turkey (Türkiye)

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Afyonkarahisar, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Çanakkale, , Turkey (Türkiye)

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Çorum, , Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Diyarbakır, , Turkey (Türkiye)

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Düzce, , Turkey (Türkiye)

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Elâzığ, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Hatay, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Karaman, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Abu Dhabi, , United Arab Emirates

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Dubai, , United Arab Emirates

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Countries

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Algeria Argentina Australia Austria Bahrain Brazil China Colombia Costa Rica Czechia Egypt India Indonesia Italy Jordan Kuwait Lebanon Malaysia Mexico Netherlands Oman Panama Poland Russia Saudi Arabia South Africa South Korea Spain Taiwan Tunisia Turkey (Türkiye) United Arab Emirates

References

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Al Rubeaan K, Banah F, Alruwaily FG, Sheshah E, Alnaqeb D, AlQahtani AM, Ewais D, Al Juhani N, Hassan AH, Youssef AM. Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme. BMJ Open. 2023 Aug 30;13(8):e063586. doi: 10.1136/bmjopen-2022-063586.

Reference Type DERIVED
PMID: 37648382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36342972 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35857060 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35546275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32868349 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32003099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31468637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31297947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31215715 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30486889 (View on PubMed)

Other Identifiers

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D1690R00002

Identifier Type: -

Identifier Source: org_study_id

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