Clinical trial NCT02465515: Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Official title: A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: cardiovascular events /outcomes
Type 2 diabetes mellitus
albiglutide
glucagon-like peptide-1 receptor agonist
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2015-06-08
Enrollment: 9463
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.


Eligibility criteria: Inclusion Criteria:

* Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Diagnosis of type 2 diabetes.
* Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
* HbA1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
* Able and willing to provide informed consent.

Exclusion Criteria:

* Severely reduced kidney function: eGFR \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
* Use of a GLP-1 receptor agonist at Screening.
* Severe gastroparesis
* History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
* Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
* Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
* Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
* Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
* Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
* Any other reason the investigator deems the subject to be unsuitable for the study.

Primary outcomes:
measure: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period
timeFrame: Median of 1.65 person years for CV follow-up time period
Secondary outcomes:
measure: Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina
timeFrame: Median of 1.65 person years for CV follow-up time period
measure: Time to Adjudicated CV Death
timeFrame: Median of 1.65 person years for the CV follow-up time period
measure: Time to First Occurrence of Adjudicated MI
timeFrame: Median of 1.65 person years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated Stroke
timeFrame: Median of 1.65 person years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)
timeFrame: Median of 1.65 person years for CV follow-up time period
measure: Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start
timeFrame: Up to 2.7 years
measure: Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start
timeFrame: Up to 2.7 years
measure: Percentage of Participants Achieving Composite Metabolic Endpoint
timeFrame: Months 8, 16, 24 and final assessment (up to 2.7 years)
measure: Time to First Occurrence of a Clinically Important Microvascular Event
timeFrame: Up to 2.7 years
measure: Change From Baseline in HbA1c
timeFrame: Baseline and Months 8 and 16
measure: Change From Baseline in Body Weight
timeFrame: Baseline and Months 8 and 16
measure: Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score
timeFrame: Baseline and Months 8 and 16
measure: Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score
timeFrame: Baseline and Months 8 and 16
measure: Time to Death
timeFrame: Median of 1.73 years for the Vital Status follow-up time period
measure: Number of Participants With Non-fatal Serious Adverse Events (SAEs)
timeFrame: Up to 2.7 years
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)
timeFrame: Up to 2.7 years
measure: Number of Participants With AEs of Special Interest
timeFrame: Up to 2.7 years
measure: Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula
timeFrame: Baseline and Months 8 and 16
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline and Months 8,16,24 and end of study (up to 2.7 years)
measure: Change From Baseline in Heart Rate
timeFrame: Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)
Other outcomes:
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state: Baden-Wuerttemberg
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country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Villingen-Schwenningen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Dachau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rednitzhembach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Elsterwerda
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Falkensee
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Floersheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Gelnhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Stuhr
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wardenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Kreuznach
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ludwigshafen am Rhein
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Sankt Ingbert
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Hohenmoelsen
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Jerichow
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Delitzsch
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Oschatz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Riesa
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schkeuditz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Dortmund
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Alexandroupolis
country: Greece
facility: GSK Investigational Site
city: Athens,
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Haidari, Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Lamia
country: Greece
facility: GSK Investigational Site
city: Nikaia Piraeus
country: Greece
facility: GSK Investigational Site
city: Pireas
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Baja
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Eger
country: Hungary
facility: GSK Investigational Site
city: Gödöllő
country: Hungary
facility: GSK Investigational Site
city: Hatvan
country: Hungary
facility: GSK Investigational Site
city: Komarom
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Sátoraljaújhely
country: Hungary
facility: GSK Investigational Site
city: Chieti
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Catanzaro
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Parma
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Arenzano (GE)
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Bergamo
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Vigevano (PV)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Ancona
country: Italy
facility: GSK Investigational Site
state: Marche
city: Ascoli Piceno
country: Italy
facility: GSK Investigational Site
state: Marche
city: Bari
country: Italy
facility: GSK Investigational Site
state: Puglia
city: San Giovanni Rotondo (FG)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Olbia (OT)
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Siena
country: Italy
facility: GSK Investigational Site
state: Toscana
city: S.Andrea Delle Fratte - S. Sisto (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggido
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwondo
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Aguascalientes, Ags
country: Mexico
facility: GSK Investigational Site
state: Aguascalientes
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Tlaquepaque
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey NL
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Queretaro
country: Mexico
facility: GSK Investigational Site
state: Querétaro
city: Mazatlán
country: Mexico
facility: GSK Investigational Site
state: Sinaloa
city: Mazatlán
country: Mexico
facility: GSK Investigational Site
state: Sinaloa
city: Mérida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Aguascalientes
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Gouda
country: Netherlands
facility: GSK Investigational Site
city: Hardenberg
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hoogeveen
country: Netherlands
facility: GSK Investigational Site
city: Meppel
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Sneek
country: Netherlands
facility: GSK Investigational Site
city: Hoenefoss
country: Norway
facility: GSK Investigational Site
city: Kolbjørnsvik
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Trujillo
country: Peru
facility: GSK Investigational Site
state: La Libertad
city: Callao
country: Peru
facility: GSK Investigational Site
state: Lima
city: San Martin de Porres
country: Peru
facility: GSK Investigational Site
state: Lima
city: Arequipa
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Piura
country: Peru
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Laoag City
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gniewkowo
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wierzchoslawice
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ivanovo
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Krasnodar
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Voronezh
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
state: Free State
city: Tongaat
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Houghton
country: South Africa
facility: GSK Investigational Site
city: Kuilsrivier
country: South Africa
facility: GSK Investigational Site
city: Paarl
country: South Africa
facility: GSK Investigational Site
city: Pinelands
country: South Africa
facility: GSK Investigational Site
city: Umhlanga
country: South Africa
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Almeria
country: Spain
facility: GSK Investigational Site
city: Alzira/Valencia
country: Spain
facility: GSK Investigational Site
city: Badalona / Barcelona
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Boadilla Del Monte (Madrid)
country: Spain
facility: GSK Investigational Site
city: Canet De Mar - Barcelona
country: Spain
facility: GSK Investigational Site
city: Cangas Del Narcea/Asturias
country: Spain
facility: GSK Investigational Site
city: Centelles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Córdoba
country: Spain
facility: GSK Investigational Site
city: Elche
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: León
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Pontevedra
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Sagunto/Valencia
country: Spain
facility: GSK Investigational Site
city: San Juan (Alicante)
country: Spain
facility: GSK Investigational Site
city: Sanlucar De Barrameda - Cádiz
country: Spain
facility: GSK Investigational Site
city: Santa Coloma De Gramanet (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Santiago De Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo-Pontevedra
country: Spain
facility: GSK Investigational Site
city: Borås
country: Sweden
facility: GSK Investigational Site
city: Eksjö
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Härnösand
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Ljungby
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Rättvik
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Hualien
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Pathumthani
country: Thailand
facility: GSK Investigational Site
city: Songkla
country: Thailand
facility: GSK Investigational Site
city: Chernivtsi
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kherson
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Mykolaiv
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Poltava
country: Ukraine
facility: GSK Investigational Site
city: Uzhgorod
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
city: Soham
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
state: Derbyshire
city: Romford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Aberdeen
country: United Kingdom
facility: GSK Investigational Site
city: Axbridge, Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Ayr
country: United Kingdom
facility: GSK Investigational Site
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Dumfries
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Fife
country: United Kingdom
facility: GSK Investigational Site
city: Fife
country: United Kingdom
facility: GSK Investigational Site
city: Gloucester
country: United Kingdom
facility: GSK Investigational Site
city: Lancaster
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Newport
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Rotherham
country: United Kingdom
facility: GSK Investigational Site
city: Sidcup, Kent
country: United Kingdom
facility: GSK Investigational Site
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
city: Wigan
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: John McMurray, Stefano Del Prato, Adrian Hernandez, Larry Leiter, Chris Granger, Ralph D'Agostino, Jennifer Green, Kristina Sigmon, Anne Rosenberg Nigel Jones, Karl Thorpe, Matt Somerville, Salim Janmohamed. Albiglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Cardiovascular Disease. Lancet. 2018
citation: O'Brien EC, Raman SR, Ellis A, Hammill BG, Berdan LG, Rorick T, Janmohamed S, Lampron Z, Hernandez AF, Curtis LH. The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. Trials. 2021 Jul 19;22(1):465. doi: 10.1186/s13063-021-05397-0.
citation: Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.
citation: Green JB, Hernandez AF, D'Agostino RB, Granger CB, Janmohamed S, Jones NP, Leiter LA, Noronha D, Russell R, Sigmon K, Del Prato S, McMurray JJV. Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus-Rationale, design, and baseline characteristics. Am Heart J. 2018 Sep;203:30-38. doi: 10.1016/j.ahj.2018.03.030. Epub 2018 Jun 12.
citation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.