Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465515
• Other study ID #: 116174
• Secondary ID: 2014-001824-32
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2015
• Est. completion date: March 14, 2018

Study information

• Verified date: February 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9463
• Est. completion date: March 14, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• Albiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
• Albiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
• Albiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Adrogue	Buenos Aires
Argentina	GSK Investigational Site	Bahia Blanca	Buenos Aires
Argentina	GSK Investigational Site	Berazategui
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba
Argentina	GSK Investigational Site	Córdoba	Córdova
Argentina	GSK Investigational Site	Godoy Cruz	Mendoza
Argentina	GSK Investigational Site	La Plata
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Pergamino	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	San Rafael	Mendoza
Argentina	GSK Investigational Site	Santa Fe
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Roeselare
Bulgaria	GSK Investigational Site	Byala
Bulgaria	GSK Investigational Site	Gabrovo
Bulgaria	GSK Investigational Site	Montana
Bulgaria	GSK Investigational Site	Sevlievo
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Stara Zagora
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Brossard	Quebec
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Cambridge	Ontario
Canada	GSK Investigational Site	Chicoutimi	Quebec
Canada	GSK Investigational Site	Cornwall	Ontario
Canada	GSK Investigational Site	Corunna	Ontario
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Smiths Falls	Ontario
Canada	GSK Investigational Site	St-Charles-Borromée	Quebec
Canada	GSK Investigational Site	St-Lambert	Quebec
Canada	GSK Investigational Site	St. John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois-Rivieres	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czechia	GSK Investigational Site	Beroun
Czechia	GSK Investigational Site	Krnov
Czechia	GSK Investigational Site	Olomouc
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Praha 1
Czechia	GSK Investigational Site	Praha 10
Czechia	GSK Investigational Site	Praha 2
Czechia	GSK Investigational Site	Praha 4
Czechia	GSK Investigational Site	Praha 5
Czechia	GSK Investigational Site	Pribram 1
Czechia	GSK Investigational Site	Uherske Hradiste
Czechia	GSK Investigational Site	Usti nad Labem
Czechia	GSK Investigational Site	Zlin
Denmark	GSK Investigational Site	Copenhagen
Denmark	GSK Investigational Site	Esbjerg
Denmark	GSK Investigational Site	Frederikssund
Denmark	GSK Investigational Site	Hellerup
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Holbæk
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	København NV
Denmark	GSK Investigational Site	København S
Denmark	GSK Investigational Site	Roskilde
France	GSK Investigational Site	Amiens Cedex 1
France	GSK Investigational Site	Broglie
France	GSK Investigational Site	Corbeil-Essonnes
France	GSK Investigational Site	La Rochelle Cedex 1
France	GSK Investigational Site	Nantes cedex 2
France	GSK Investigational Site	Narbonne
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pau Cedex
France	GSK Investigational Site	Pierre-Bénite
France	GSK Investigational Site	Strasbourg cedex
France	GSK Investigational Site	Vandœuvre-lès-Nancy
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Bad Kreuznach	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dachau	Bayern
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Dortmund
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Elsterwerda	Brandenburg
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Falkensee	Brandenburg
Germany	GSK Investigational Site	Floersheim	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Gelnhausen	Hessen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hildesheim	Niedersachsen
Germany	GSK Investigational Site	Hohenmoelsen	Sachsen-Anhalt
Germany	GSK Investigational Site	Jerichow	Sachsen-Anhalt
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kleve	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzg	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Ludwigsburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ludwigshafen am Rhein	Rheinland-Pfalz
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim
Germany	GSK Investigational Site	Muenchen
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oschatz	Sachsen
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rednitzhembach	Bayern
Germany	GSK Investigational Site	Riesa	Sachsen
Germany	GSK Investigational Site	Sankt Ingbert	Saarland
Germany	GSK Investigational Site	Schkeuditz	Sachsen
Germany	GSK Investigational Site	Stuhr	Niedersachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wardenburg	Niedersachsen
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Greece	GSK Investigational Site	Alexandroupolis
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens,
Greece	GSK Investigational Site	Haidari, Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Ioannina
Greece	GSK Investigational Site	Lamia
Greece	GSK Investigational Site	Nikaia Piraeus
Greece	GSK Investigational Site	Pireas
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin
Hungary	GSK Investigational Site	Baja
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Eger
Hungary	GSK Investigational Site	Gödöllo
Hungary	GSK Investigational Site	Hatvan
Hungary	GSK Investigational Site	Komarom
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Sátoraljaújhely
Italy	GSK Investigational Site	Ancona	Marche
Italy	GSK Investigational Site	Arenzano (GE)	Liguria
Italy	GSK Investigational Site	Ascoli Piceno	Marche
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Catanzaro	Calabria
Italy	GSK Investigational Site	Chieti	Abruzzo
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Olbia (OT)	Sardegna
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Ravenna	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	S.Andrea Delle Fratte - S. Sisto (PG)	Umbria
Italy	GSK Investigational Site	San Giovanni Rotondo (FG)	Puglia
Italy	GSK Investigational Site	Siena	Toscana
Italy	GSK Investigational Site	Vigevano (PV)	Lombardia
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggido
Korea, Republic of	GSK Investigational Site	Kangwondo
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon
Korea, Republic of	GSK Investigational Site	Suwon, Kyonggi-do
Mexico	GSK Investigational Site	Aguascalientes
Mexico	GSK Investigational Site	Aguascalientes, Ags	Aguascalientes
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mazatlán	Sinaloa
Mexico	GSK Investigational Site	Mazatlán	Sinaloa
Mexico	GSK Investigational Site	Mérida	Yucatán
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Monterrey NL	Nuevo León
Mexico	GSK Investigational Site	Queretaro	Querétaro
Mexico	GSK Investigational Site	Tlaquepaque	Jalisco
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Gouda
Netherlands	GSK Investigational Site	Hardenberg
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Hoogeveen
Netherlands	GSK Investigational Site	Meppel
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sneek
Norway	GSK Investigational Site	Hoenefoss
Norway	GSK Investigational Site	Kolbjørnsvik
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Stavanger
Peru	GSK Investigational Site	Arequipa
Peru	GSK Investigational Site	Callao	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Piura
Peru	GSK Investigational Site	San Martin de Porres	Lima
Peru	GSK Investigational Site	Trujillo	La Libertad
Philippines	GSK Investigational Site	Cebu City
Philippines	GSK Investigational Site	Iloilo City
Philippines	GSK Investigational Site	Laoag City
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gniewkowo
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wierzchoslawice
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Russian Federation	GSK Investigational Site	Arkhangelsk
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ivanovo
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Krasnodar
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Nizhny Novgorod
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Rostov-on-Don
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Voronezh
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
South Africa	GSK Investigational Site	Bloemfontein	Free State
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Houghton
South Africa	GSK Investigational Site	Kuilsrivier
South Africa	GSK Investigational Site	Paarl
South Africa	GSK Investigational Site	Pinelands
South Africa	GSK Investigational Site	Tongaat	KwaZulu- Natal
South Africa	GSK Investigational Site	Umhlanga
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Almeria
Spain	GSK Investigational Site	Alzira/Valencia
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Badalona / Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Boadilla Del Monte (Madrid)
Spain	GSK Investigational Site	Canet De Mar - Barcelona
Spain	GSK Investigational Site	Cangas Del Narcea/Asturias
Spain	GSK Investigational Site	Centelles (Barcelona)
Spain	GSK Investigational Site	Córdoba
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	León
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Pontevedra
Spain	GSK Investigational Site	Pozuelo De Alarcón/Madrid
Spain	GSK Investigational Site	Sagunto/Valencia
Spain	GSK Investigational Site	San Juan (Alicante)
Spain	GSK Investigational Site	Sanlucar De Barrameda - Cádiz
Spain	GSK Investigational Site	Santa Coloma De Gramanet (Barcelona)
Spain	GSK Investigational Site	Santiago De Compostela
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Tarrasa, Barcelona
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo-Pontevedra
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Eksjö
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Härnösand
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Kristianstad
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Ljungby
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Rättvik
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Umeå
Sweden	GSK Investigational Site	Uppsala
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Hualien
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai
Thailand	GSK Investigational Site	Pathumthani
Thailand	GSK Investigational Site	Songkla
Ukraine	GSK Investigational Site	Chernivtsi
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kherson
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Mykolaiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Poltava
Ukraine	GSK Investigational Site	Uzhgorod
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Zaporizhzhya
United Kingdom	GSK Investigational Site	Aberdeen
United Kingdom	GSK Investigational Site	Axbridge, Somerset
United Kingdom	GSK Investigational Site	Ayr
United Kingdom	GSK Investigational Site	Blackpool
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Chesterfield	Derbyshire
United Kingdom	GSK Investigational Site	Dumfries
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Fife
United Kingdom	GSK Investigational Site	Fife
United Kingdom	GSK Investigational Site	Gloucester
United Kingdom	GSK Investigational Site	Lancaster
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Newport
United Kingdom	GSK Investigational Site	Northwood	Middlesex
United Kingdom	GSK Investigational Site	Oxford
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United Kingdom	GSK Investigational Site	Sidcup, Kent
United Kingdom	GSK Investigational Site	Soham	Cambridgeshire
United Kingdom	GSK Investigational Site	Trowbridge
United Kingdom	GSK Investigational Site	Trowbridge	Wiltshire
United Kingdom	GSK Investigational Site	Wigan
United States	GSK Investigational Site	Albuquerque	New Mexico
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United States	GSK Investigational Site	Bradenton	Florida
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United States	GSK Investigational Site	Dallas	Texas
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United States	GSK Investigational Site	Lomita	California
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United States	GSK Investigational Site	Los Angeles	California
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United States	GSK Investigational Site	Madison	Wisconsin
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United States	GSK Investigational Site	Memphis	Tennessee
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United States	GSK Investigational Site	Myrtle Beach	South Carolina
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United States	GSK Investigational Site	New Haven	Connecticut
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United States	GSK Investigational Site	North Massapequa	New York
United States	GSK Investigational Site	Northridge	California
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United States	GSK Investigational Site	Omaha	Nebraska
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United States	GSK Investigational Site	Penndel	Pennsylvania
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United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Ponte Vedra	Florida
United States	GSK Investigational Site	Port Charlotte	Florida
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Rocky Mount	North Carolina
United States	GSK Investigational Site	Saint Cloud	Minnesota
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Paul	Minnesota
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Marino	California
United States	GSK Investigational Site	San Ramon	California
United States	GSK Investigational Site	Sandusky	Ohio
United States	GSK Investigational Site	Schertz	Texas
United States	GSK Investigational Site	Searcy	Arkansas
United States	GSK Investigational Site	Sellersville	Pennsylvania
United States	GSK Investigational Site	Simi Valley	California
United States	GSK Investigational Site	Snellville	Georgia
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Ohio
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Suite 101	Texas
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Tucker	Georgia
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Wellington	Florida
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period	Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction [MI] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.	Median of 1.65 person years for CV follow-up time period
Secondary	Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina	Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Median of 1.65 person years for CV follow-up time period
Secondary	Time to Adjudicated CV Death	Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Median of 1.65 person years for the CV follow-up time period
Secondary	Time to First Occurrence of Adjudicated MI	Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Median of 1.65 person years for CV follow-up time period
Secondary	Time to First Occurrence of Adjudicated Stroke	Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Median of 1.65 person years for CV follow-up time period
Secondary	Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)	Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Median of 1.65 person years for CV follow-up time period
Secondary	Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start	Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline.	Up to 2.7 years
Secondary	Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start	Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin).	Up to 2.7 years
Secondary	Percentage of Participants Achieving Composite Metabolic Endpoint	Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin [HbA1c] <=7% ) with no severe hypoglycemic incidents and weight gain < 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight.	Months 8, 16, 24 and final assessment (up to 2.7 years)
Secondary	Time to First Occurrence of a Clinically Important Microvascular Event	Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period.	Up to 2.7 years
Secondary	Change From Baseline in HbA1c	Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented.	Baseline and Months 8 and 16
Secondary	Change From Baseline in Body Weight	Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.	Baseline and Months 8 and 16
Secondary	Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score	The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as [(raw score minus lowest possible raw score)/possible raw score range] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.	Baseline and Months 8 and 16
Secondary	Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score	The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.	Baseline and Months 8 and 16
Secondary	Time to Death	Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period.	Median of 1.73 years for the Vital Status follow-up time period
Secondary	Number of Participants With Non-fatal Serious Adverse Events (SAEs)	SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.	Up to 2.7 years
Secondary	Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)	The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.	Up to 2.7 years
Secondary	Number of Participants With AEs of Special Interest	The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee [PAC]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase [GGT]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported.	Up to 2.7 years
Secondary	Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula	Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented.	Baseline and Months 8 and 16
Secondary	Change From Baseline in Blood Pressure	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.	Baseline and Months 8,16,24 and end of study (up to 2.7 years)
Secondary	Change From Baseline in Heart Rate	Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.	Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)