Effect of Efpeglenatide on Cardiovascular Outcomes

NCT ID: NCT03496298

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4076 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-27
• Study Completion Date: 2020-12-10

Brief Summary

Primary Objective:

To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.

Secondary Objectives:

To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:

• 3-point MACE.
• Expanded CV outcome.
• Composite outcome of new or worsening nephropathy.

To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

Detailed Description

The study duration per participant was up to approximately 36 months.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution for injection

Route of administration: SC

Efpeglenatide 4 mg

Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.

Group Type: EXPERIMENTAL

Efpeglenatide (SAR439977)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection,

Route of administration: SC

Efpeglenatide 6 mg

Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.

Group Type: EXPERIMENTAL

Efpeglenatide (SAR439977)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection,

Route of administration: SC

Interventions

Efpeglenatide (SAR439977)

Pharmaceutical form: Solution for injection,

Route of administration: SC

Intervention Type: DRUG

Placebo

Pharmaceutical form: Solution for injection

Route of administration: SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage.
• Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.
• Female participants agreed to follow contraceptive guidance.
• Signed written informed consent.

Exclusion Criteria

• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
• History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
• Personal or family history of medullary thyroid cancer.
• Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
• Hospitalization for hypertensive emergency within 3 months prior to randomization.
• Planned coronary procedure or surgery after randomization.
• No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
• Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
• Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
• Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.
• Antihyperglycemic treatment had not been stable within 3 months prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 8400032

Sheffield, Alabama, United States

Investigational Site Number 8400014

Gilbert, Arizona, United States

Investigational Site Number 8400012

Surprise, Arizona, United States

Investigational Site Number 8400046

Tucson, Arizona, United States

Investigational Site Number 8400022

Beverly Hills, California, United States

Investigational Site Number 8400065

Concord, California, United States

Investigational Site Number 8400060

Greenbrae, California, United States

Investigational Site Number 8400084

Long Beach, California, United States

Investigational Site Number 8400002

Los Gatos, California, United States

Investigational Site Number 8400085

Northridge, California, United States

Investigational Site Number 8400082

Pomona, California, United States

Investigational Site Number 8400025

Sacramento, California, United States

Investigational Site Number 8400064

Englewood, Colorado, United States

Investigational Site Number 8400019

Hamden, Connecticut, United States

Investigational Site Number 8400023

Waterbury, Connecticut, United States

Investigational Site Number 8400091

Hialeah, Florida, United States

Investigational Site Number 8400040

Hollywood, Florida, United States

Investigational Site Number 8400073

Hudson, Florida, United States

Investigational Site Number 8400011

Jacksonville, Florida, United States

Investigational Site Number 8400017

Jacksonville, Florida, United States

Investigational Site Number 8400042

Jacksonville, Florida, United States

Investigational Site Number 8400027

Miami, Florida, United States

Investigational Site Number 8400051

Miami, Florida, United States

Investigational Site Number 8400041

New Port Richey, Florida, United States

Investigational Site Number 8400059

Ormond Beach, Florida, United States

Investigational Site Number 8400006

Macon, Georgia, United States

Investigational Site Number 8400008

Roswell, Georgia, United States

Investigational Site Number 8400081

Idaho Falls, Idaho, United States

Investigational Site Number 8400095

Arlington Heights, Illinois, United States

Investigational Site Number 8400070

Chicago, Illinois, United States

Investigational Site Number 8400036

Crystal Lake, Illinois, United States

Investigational Site Number 8400030

New Albany, Indiana, United States

Investigational Site Number 8400074

Topeka, Kansas, United States

Investigational Site Number 8400077

Owensboro, Kentucky, United States

Investigational Site Number 8400043

Paris, Kentucky, United States

Investigational Site Number 8400034

Alexandria, Louisiana, United States

Investigational Site Number 8400079

Monroe, Louisiana, United States

Investigational Site Number 8400013

New Orleans, Louisiana, United States

Investigational Site Number 8400047

Oxon Hill, Maryland, United States

Investigational Site Number 8400001

Flint, Michigan, United States

Investigational Site Number 8400061

Flint, Michigan, United States

Investigational Site Number 8400010

Troy, Michigan, United States

Investigational Site Number 8400005

Troy, Michigan, United States

Investigational Site Number 8400024

Saint Paul, Minnesota, United States

Investigational Site Number 8400045

St Louis, Missouri, United States

Investigational Site Number 8400071

Billings, Montana, United States

Investigational Site Number 8400028

Great Falls, Montana, United States

Investigational Site Number 8400086

Kalispell, Montana, United States

Investigational Site Number 8400037

Las Vegas, Nevada, United States

Investigational Site Number 8400087

Raritan, New Jersey, United States

Investigational Site Number 8400056

Staten Island, New York, United States

Investigational Site Number 8400018

The Bronx, New York, United States

Investigational Site Number 8400076

Greenville, North Carolina, United States

Investigational Site Number 8400007

Morehead City, North Carolina, United States

Investigational Site Number 8400093

Morehead City, North Carolina, United States

Investigational Site Number 8400094

Morganton, North Carolina, United States

Investigational Site Number 8400029

Fargo, North Dakota, United States

Investigational Site Number 8400031

Columbus, Ohio, United States

Investigational Site Number 8400078

Lorain, Ohio, United States

Investigational Site Number 8400072

Bend, Oregon, United States

Investigational Site Number 8400067

Beaver, Pennsylvania, United States

Investigational Site Number 8400096

Philadelphia, Pennsylvania, United States

Investigational Site Number 8400021

Pittsburgh, Pennsylvania, United States

Investigational Site Number 8400015

Greer, South Carolina, United States

Investigational Site Number 8400063

Murrells Inlet, South Carolina, United States

Investigational Site Number 8400044

Rapid City, South Dakota, United States

Investigational Site Number 8400016

Memphis, Tennessee, United States

Investigational Site Number 8400009

Nashville, Tennessee, United States

Investigational Site Number 8400055

Corpus Christi, Texas, United States

Investigational Site Number 8400097

Dallas, Texas, United States

Investigational Site Number 8400088

El Paso, Texas, United States

Investigational Site Number 8400058

Fort Worth, Texas, United States

Investigational Site Number 8400069

Houston, Texas, United States

Investigational Site Number 8400089

Houston, Texas, United States

Investigational Site Number 8400092

Richmond, Texas, United States

Investigational Site Number 8400033

Waco, Texas, United States

Investigational Site Number 8400039

Salt Lake City, Utah, United States

Investigational Site Number 8400052

Norfolk, Virginia, United States

Investigational Site Number 8400049

Manitowoc, Wisconsin, United States

Investigational Site Number 0320009

Buenos Aires, , Argentina

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Caba, , Argentina

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Caba, , Argentina

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Caba, , Argentina

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Caba, , Argentina

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Capital Federal, , Argentina

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Capital Federal, , Argentina

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Corrientes, , Argentina

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Corrientes, , Argentina

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Godoy Cruz, , Argentina

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Mar del Plata, , Argentina

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Merlo, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Salta, , Argentina

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Salta, , Argentina

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San Isidro, , Argentina

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Santa Rosa, , Argentina

Investigational Site Number 1000011

Blagoevgrad, , Bulgaria

Investigational Site Number 1000014

Dimitrovgrad, , Bulgaria

Investigational Site Number 1000017

Gabrovo, , Bulgaria

Investigational Site Number 1000007

Kazanlak, , Bulgaria

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Kyustendil, , Bulgaria

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Lovech, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

Investigational Site Number 1000016

Yambol, , Bulgaria

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Barrie, , Canada

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Brampton, , Canada

Investigational Site Number 1240018

Burlington, , Canada

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Burlington, , Canada

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Calgary, , Canada

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Calgary, , Canada

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Chicoutimi, , Canada

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Concord, , Canada

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Etobicoke, , Canada

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Greater Sudbury, , Canada

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Lévis, , Canada

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London, , Canada

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London, , Canada

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Mirabel, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Oakville, , Canada

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Oshawa, , Canada

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Ottawa, , Canada

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Peterborough, , Canada

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Pointe-Claire, , Canada

Investigational Site Number 1240010

Québec, , Canada

Investigational Site Number 1240019

Red Deer, , Canada

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Sherbrooke, , Canada

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Toronto, , Canada

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Vancouver, , Canada

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Victoria, , Canada

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Victoriaville, , Canada

Investigational Site Number 1520012

Antofagasta, , Chile

Investigational Site Number 1520008

Concepción, , Chile

Investigational Site Number 1520013

Santiago, , Chile

Investigational Site Number 1520002

Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

Investigational Site Number 1520006

Temuco, , Chile

Investigational Site Number 1520004

Viña del Mar, , Chile

Investigational Site Number 2080004

Aarhus N, , Denmark

Investigational Site Number 2080005

Esbjerg, , Denmark

Investigational Site Number 2080001

Hellerup, , Denmark

Investigational Site Number 2080003

Hvidovre, , Denmark

Investigational Site Number 2080002

København NV, , Denmark

Investigational Site Number 2330002

Pärnu, , Estonia

Investigational Site Number 2330001

Tallinn, , Estonia

Investigational Site Number 2330003

Viljandi, , Estonia

Investigational Site Number 2460002

Helsinki, , Finland

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Jyväskylä, , Finland

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Kuopio, , Finland

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Oulu, , Finland

Investigational Site Number 2760006

Berlin, , Germany

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Berlin, , Germany

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Essen, , Germany

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Frankfurt am Main, , Germany

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Münster, , Germany

Investigational Site Number 2760003

Oldenburg in Holstein, , Germany

Investigational Site Number 2760002

Pirna, , Germany

Investigational Site Number 2760007

Rotenburg an der Fulda, , Germany

Investigational Site Number 3480012

Balatonfüred, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Komárom, , Hungary

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Mosonmagyaróvár, , Hungary

Investigational Site Number 3480007

Székesfehérvár, , Hungary

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Zalaegerszeg, , Hungary

Investigational Site Number 3560001

Belagavi, , India

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Gurgaon, , India

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Kolkata, , India

Investigational Site Number 3560006

Lucknow, , India

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New Delhi, , India

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New Delhi, , India

Investigational Site Number 3560010

Pune, , India

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Pune, , India

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Vellore, , India

Investigational Site Number 3800006

Catania, , Italy

Investigational Site Number 3800003

Catanzaro, , Italy

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Catanzaro, , Italy

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Chieti, , Italy

Investigational Site Number 3800001

Milan, , Italy

Investigational Site Number 3800004

Roma, , Italy

Investigational Site Number 4280004

Daugavpils, , Latvia

Investigational Site Number 4280002

Liepāja, , Latvia

Investigational Site Number 4280001

Riga, , Latvia

Investigational Site Number 4280003

Sigulda, , Latvia

Investigational Site Number 4400001

Kaunas, , Lithuania

Investigational Site Number 4400002

Kaunas, , Lithuania

Investigational Site Number 4400003

Klaipėda, , Lithuania

Investigational Site Number 4400004

Vilnius, , Lithuania

Investigational Site Number 4840004

Actopan, , Mexico

Investigational Site Number 4840007

Aguascalientes, , Mexico

Investigational Site Number 4840009

Aguascalientes, , Mexico

Investigational Site Number 4840013

Aguascalientes, , Mexico

Investigational Site Number 4840014

Chihuahua City, , Mexico

Investigational Site Number 4840002

Cuernavaca, , Mexico

Investigational Site Number 4840016

Durango, , Mexico

Investigational Site Number 4840015

Durango, , Mexico

Investigational Site Number 4840006

Guadalajara, , Mexico

Investigational Site Number 4840003

Guadalajara, , Mexico

Investigational Site Number 4840005

Guadalajara, , Mexico

Investigational Site Number 4840011

Monterrey, , Mexico

Investigational Site Number 4840010

Monterrey, , Mexico

Investigational Site Number 4840001

Monterrey, , Mexico

Investigational Site Number 5780002

Hamar, , Norway

Investigational Site Number 5780001

Oslo, , Norway

Investigational Site Number 5780003

Stavanger, , Norway

Investigational Site Number 6040007

Lima, , Peru

Investigational Site Number 6040004

Lima, , Peru

Investigational Site Number 6040003

Lima, , Peru

Investigational Site Number 6040006

Lima, , Peru

Investigational Site Number 6040001

Lima, , Peru

Investigational Site Number 6040005

Lima, , Peru

Investigational Site Number 6040002

Piura, , Peru

Investigational Site Number 6160017

Bialystok, , Poland

Investigational Site Number 6160018

Bydgoszcz, , Poland

Investigational Site Number 6160015

Bydgoszcz, , Poland

Investigational Site Number 6160016

Gdansk, , Poland

Investigational Site Number 6160012

Gdansk, , Poland

Investigational Site Number 6160005

Katowice, , Poland

Investigational Site Number 6160006

Płock, , Poland

Investigational Site Number 6160011

Skierniewice, , Poland

Investigational Site Number 6160013

Skorzewo, , Poland

Investigational Site Number 6160010

Szczecin, , Poland

Investigational Site Number 6160007

Torun, , Poland

Investigational Site Number 6160009

Torun, , Poland

Investigational Site Number 6160014

Tychy, , Poland

Investigational Site Number 6160002

Warsaw, , Poland

Investigational Site Number 6160004

Wroclaw, , Poland

Investigational Site Number 6420007

Bacau, , Romania

Investigational Site Number 6420001

Brasov, , Romania

Investigational Site Number 6420011

Brasov, , Romania

Investigational Site Number 6420009

Bucharest, , Romania

Investigational Site Number 6420012

Oradea, , Romania

Investigational Site Number 6420005

Oradea, , Romania

Investigational Site Number 6420010

Oradea, , Romania

Investigational Site Number 6420008

Ploieşti, , Romania

Investigational Site Number 6420002

Târgu Mureş, , Romania

Investigational Site Number 6420003

Târgu Mureş, , Romania

Investigational Site Number 6430018

Kaliningrad, , Russia

Investigational Site Number 6430014

Kazan', , Russia

Investigational Site Number 6430001

Kemerovo, , Russia

Investigational Site Number 6430017

Krasnogorsk, , Russia

Investigational Site Number 6430004

Moscow, , Russia

Investigational Site Number 6430005

Moscow, , Russia

Investigational Site Number 6430002

Moscow, , Russia

Investigational Site Number 6430015

Moscow, , Russia

Investigational Site Number 6430009

Novosibirsk, , Russia

Investigational Site Number 6430019

Novosibirsk, , Russia

Investigational Site Number 6430006

Saint Petersburg, , Russia

Investigational Site Number 6430010

Saint Petersburg, , Russia

Investigational Site Number 6430011

Saint Petersburg, , Russia

Investigational Site Number 6430013

Saint Petersburg, , Russia

Investigational Site Number 6430016

Saint Petersburg, , Russia

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Saint Petersburg, , Russia

Investigational Site Number 6430003

Saratov, , Russia

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Saratov, , Russia

Investigational Site Number 6880001

Belgrade, , Serbia

Investigational Site Number 6880002

Belgrade, , Serbia

Investigational Site Number 6880003

Belgrade, , Serbia

Investigational Site Number 6880005

Belgrade, , Serbia

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Kragujevac, , Serbia

Investigational Site Number 6880006

Novi Sad, , Serbia

Investigational Site Number 7030007

Bratislava, , Slovakia

Investigational Site Number 7030001

Košice, , Slovakia

Investigational Site Number 7030004

Košice, , Slovakia

Investigational Site Number 7030003

Kráľovský Chlmec, , Slovakia

Investigational Site Number 7030009

Moldava nad Bodvou, , Slovakia

Investigational Site Number 7030010

Pezinok, , Slovakia

Investigational Site Number 7030006

Považská Bystrica, , Slovakia

Investigational Site Number 7030005

Prešov, , Slovakia

Investigational Site Number 7030008

Rožňava, , Slovakia

Investigational Site Number 7030011

Štúrovo, , Slovakia

Investigational Site Number 7030002

Trebišov, , Slovakia

Investigational Site Number 7030012

Trenčín, , Slovakia

Investigational Site Number 7100007

Bloemfontein, , South Africa

Investigational Site Number 7100005

Cape Town, , South Africa

Investigational Site Number 7100006

Cape Town, , South Africa

Investigational Site Number 7100003

Johannesburg, , South Africa

Investigational Site Number 7100001

Johannesburg, , South Africa

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Parow, , South Africa

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Rivonia, , South Africa

Investigational Site Number 7100008

Umhlanga Rocks Suburb, , South Africa

Investigational Site Number 4100006

Guri-si, Gyeonggi-do, South Korea

Investigational Site Number 4100007

Busan, , South Korea

Investigational Site Number 4100005

Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Wŏnju, , South Korea

Investigational Site Number 7240008

Alcorcón, , Spain

Investigational Site Number 7240002

Barcelona, , Spain

Investigational Site Number 7240009

Barcelona, , Spain

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Granada, , Spain

Investigational Site Number 7240010

Madrid, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

Investigational Site Number 7240011

Málaga, , Spain

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Olot, , Spain

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San Sebastián de los Reyes, , Spain

Investigational Site Number 7240013

Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Kristianstad, , Sweden

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Malmo, , Sweden

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Skövde, , Sweden

Investigational Site Number 7520001

Stockholm, , Sweden

Investigational Site Number 7920005

Adana, , Turkey (Türkiye)

Investigational Site Number 7920010

Ankara, , Turkey (Türkiye)

Investigational Site Number 7920012

Antalya, , Turkey (Türkiye)

Investigational Site Number 7920015

Aydin, , Turkey (Türkiye)

Investigational Site Number 7920002

Bursa, , Turkey (Türkiye)

Investigational Site Number 7920013

Eskişehir, , Turkey (Türkiye)

Investigational Site Number 7920001

Istanbul, , Turkey (Türkiye)

Investigational Site Number 7920006

Istanbul, , Turkey (Türkiye)

Investigational Site Number 7920011

İzmit, , Turkey (Türkiye)

Investigational Site Number 7920014

Kütahya, , Turkey (Türkiye)

Investigational Site Number 7920007

Samsun, , Turkey (Türkiye)

Investigational Site Number 7920009

Sivas, , Turkey (Türkiye)

Investigational Site Number 8040006

Dnipro, , Ukraine

Investigational Site Number 8040009

Ivano-Frankivsk, , Ukraine

Investigational Site Number 8040001

Ivano-Frankivsk, , Ukraine

Investigational Site Number 8040003

Kharkiv, , Ukraine

Investigational Site Number 8040002

Kharkiv, , Ukraine

Investigational Site Number 8040007

Kiev, , Ukraine

Investigational Site Number 8040008

Kyiv, , Ukraine

Investigational Site Number 8040004

Ternopil, , Ukraine

Investigational Site Number 8040005

Vinnytsia, , Ukraine

Countries

United States; Argentina; Bulgaria; Canada; Chile; Denmark; Estonia; Finland; Germany; Hungary; India; Italy; Latvia; Lithuania; Mexico; Norway; Peru; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Sweden; Turkey (Türkiye); Ukraine

References

Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.

Reference Type: RESULT

PMID: 34215025 (View on PubMed)

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

Reference Type: DERIVED

PMID: 39963952 (View on PubMed)

Gerstein HC, Li Z, Ramasundarahettige C, Baek S, Branch KRH, Del Prato S, Lam CSP, Lopes RD, Pratley R, Rosenstock J, Sattar N. Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Circulation. 2023 Mar 28;147(13):1004-1013. doi: 10.1161/CIRCULATIONAHA.122.063716. Epub 2023 Feb 20.

Reference Type: DERIVED

PMID: 36802715 (View on PubMed)

Lam CSP, Ramasundarahettige C, Branch KRH, Sattar N, Rosenstock J, Pratley R, Del Prato S, Lopes RD, Niemoeller E, Khurmi NS, Baek S, Gerstein HC. Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Circulation. 2022 Feb 22;145(8):565-574. doi: 10.1161/CIRCULATIONAHA.121.057934. Epub 2021 Nov 14.

Reference Type: DERIVED

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Gerstein HC, Branch K, Heenan L, Del Prato S, Khurmi NS, Lam CSP, Pratley R, Rosenstock J, Sattar N. Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Diabetes Obes Metab. 2021 Feb;23(2):318-323. doi: 10.1111/dom.14223. Epub 2020 Oct 22.

Reference Type: DERIVED

PMID: 33026143 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002954-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1186-2533

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14828

Identifier Type: -

Identifier Source: org_study_id