NCT02322762

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
15,992

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
29 countries

275 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 30, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2019

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

4.6 years

First QC Date

December 19, 2014

Last Update Submit

June 8, 2022

Conditions

Keywords

Type 2 diabetes mellitusAnti-diabetic management patterns

Outcome Measures

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.

    Up to 3 Years

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Diagnosis of type 1 diabetes mellitus
  • Patient is pregnant
  • Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
  • Current treatment with chemotherapy, oral or iv steroids
  • Patient is on dialysis or has had a renal transplant
  • The patient is taking insulin as first line treatment
  • The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
  • The patient is taking herbal remedies / natural medicines as first line treatment
  • Participation in an interventional trial
  • 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).
  • Not willing to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (303)

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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Gūrgaon, 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, 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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Related Publications (10)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jesus Medina, PhD

    AstraZeneca

    STUDY DIRECTOR
  • Linong Ji, MD

    Peking University People's Hospital, China

    PRINCIPAL INVESTIGATOR
  • Bong Soo Cha, Dr.

    Severance Hospital, Yonsei University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 23, 2014

Study Start

December 30, 2014

Primary Completion

August 21, 2019

Study Completion

August 21, 2019

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations