Search / Trial NCT03496298

Effect of Efpeglenatide on Cardiovascular Outcomes
Launched by SANOFI · Apr 5, 2018

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Trial Information

Current as of June 30, 2025

Terminated

Keywords

ClinConnect Summary

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

Gender

ALL

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.

About Sanofi

Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.

Locations

Székesfehérvár, , Hungary

Monterrey, , Mexico

Belgrade, , Serbia

Pärnu, , Estonia

Tallinn, , Estonia

Oldenburg In Holstein, , Germany

Milano, , Italy

Oslo, , Norway

Kemerovo, , Russian Federation

Stockholm, , Sweden

Vancouver, , Canada

Actopan, , Mexico

Barcelona, , Spain

Valencia, , Spain

Debrecen, , Hungary

Pirna, , Germany

Balatonfüred, , Hungary

Budapest, , Hungary

Warszawa, , Poland

Sacramento, California, United States

Sofia, , Bulgaria

Santiago, , Chile

København Nv, , Denmark

Budapest, , Hungary

Roma, , Italy

Daugavpils, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Sigulda, , Latvia

Aguascalientes, , Mexico

Cuernavaca, , Mexico

Moscow, , Russian Federation

Vinnytsya, , Ukraine

Flint, Michigan, United States

Sheffield, Alabama, United States

Gilbert, Arizona, United States

Surprise, Arizona, United States

Tucson, Arizona, United States

Beverly Hills, California, United States

Concord, California, United States

Greenbrae, California, United States

Long Beach, California, United States

Los Gatos, California, United States

Northridge, California, United States

Pomona, California, United States

Englewood, Colorado, United States

Hamden, Connecticut, United States

Waterbury, Connecticut, United States

Hialeah, Florida, United States

Hollywood, Florida, United States

Hudson, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Ormond Beach, Florida, United States

Macon, Georgia, United States

Roswell, Georgia, United States

Idaho Falls, Idaho, United States

Arlington Heights, Illinois, United States

Chicago, Illinois, United States

Crystal Lake, Illinois, United States

New Albany, Indiana, United States

Topeka, Kansas, United States

Owensboro, Kentucky, United States

Paris, Kentucky, United States

Alexandria, Louisiana, United States

Monroe, Louisiana, United States

New Orleans, Louisiana, United States

Oxon Hill, Maryland, United States

Flint, Michigan, United States

Troy, Michigan, United States

Saint Paul, Minnesota, United States

Saint Louis, Missouri, United States

Billings, Montana, United States

Great Falls, Montana, United States

Kalispell, Montana, United States

Las Vegas, Nevada, United States

Raritan, New Jersey, United States

Bronx, New York, United States

Staten Island, New York, United States

Greenville, North Carolina, United States

Morehead City, North Carolina, United States

Morganton, North Carolina, United States

Fargo, North Dakota, United States

Columbus, Ohio, United States

Lorain, Ohio, United States

Bend, Oregon, United States

Beaver, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Greer, South Carolina, United States

Murrells Inlet, South Carolina, United States

Rapid City, South Dakota, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

El Paso, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Richmond, Texas, United States

Waco, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Manitowoc, Wisconsin, United States

Buenos Aires, , Argentina

Caba, , Argentina

Capital Federal, , Argentina

Corrientes, , Argentina

Godoy Cruz, , Argentina

Mar Del Plata, , Argentina

Merlo, , Argentina

Rosario, , Argentina

Salta, , Argentina

San Isidro, , Argentina

Santa Rosa, , Argentina

Blagoevgrad, , Bulgaria

Dimitrovgrad, , Bulgaria

Gabrovo, , Bulgaria

Kazanlak, , Bulgaria

Kyustendil, , Bulgaria

Lovech, , Bulgaria

Plovdiv, , Bulgaria

Ruse, , Bulgaria

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Varna, , Bulgaria

Yambol, , Bulgaria

Barrie, , Canada

Brampton, , Canada

Burlington, , Canada

Calgary, , Canada

Chicoutimi, , Canada

Concord, , Canada

Etobicoke, , Canada

Levis, , Canada

London, , Canada

Mirabel, , Canada

Montreal, , Canada

Oakville, , Canada

Oshawa, , Canada

Ottawa, , Canada

Peterborough, , Canada

Pointe Claire, , Canada

Quebec, , Canada

Red Deer, , Canada

Sherbrooke, , Canada

Sudbury, , Canada

Toronto, , Canada

Victoriaville, , Canada

Victoria, , Canada

Antofagasta, , Chile

Concepción, , Chile

Santiago, , Chile

Temuco, , Chile

Viña Del Mar, , Chile

Aarhus N, , Denmark

Esbjerg, , Denmark

Hellerup, , Denmark

Hvidovre, , Denmark

Viljandi, , Estonia

Helsinki, , Finland

Jyväskylä, , Finland

Kuopio, , Finland

Oulu, , Finland

Berlin, , Germany

Essen, , Germany

Frankfurt Am Main, , Germany

Münster, , Germany

Rotenburg An Der Fulda, , Germany

Budapest, , Hungary

Komárom, , Hungary

Mosonmagyaróvár, , Hungary

Zalaegerszeg, , Hungary

Belgaum, , India

Gurgaon, , India

Kolkata, , India

Lucknow, , India

New Delhi, , India

Pune, , India

Vellore, , India

Catania, , Italy

Catanzaro, , Italy

Chieti, , Italy

Guri Si, Gyeonggi Do, Korea, Republic Of

Busan, , Korea, Republic Of

Seoul, , Korea, Republic Of

Wonju, , Korea, Republic Of

Kaunas, , Lithuania

Klaipeda, , Lithuania

Vilnius, , Lithuania

Aguascalientes, , Mexico

Chihuahua, , Mexico

Durango, , Mexico

Guadalajara, , Mexico

Monterrey, , Mexico

Hamar, , Norway

Stavanger, , Norway

Lima, , Peru

Piura, , Peru

Bialystok, , Poland

Bydgoszcz, , Poland

Gdansk, , Poland

Katowice, , Poland

Plock, , Poland

Skierniewice, , Poland

Skorzewo, , Poland

Szczecin, , Poland

Torun, , Poland

Tychy, , Poland

Wroclaw, , Poland

Bacau, , Romania

Brasov, , Romania

Bucuresti, , Romania

Oradea, , Romania

Ploiesti, , Romania

Târgu Mureş, , Romania

Kaliningrad, , Russian Federation

Kazan, , Russian Federation

Krasnogorsk, , Russian Federation

Moscow, , Russian Federation

Novosibirsk, , Russian Federation

Saint Petersburg, , Russian Federation

Saratov, , Russian Federation

St Petersburg, , Russian Federation

St. Petersburg, , Russian Federation

Belgrade, , Serbia

Kragujevac, , Serbia

Novi Sad, , Serbia

Bratislava, , Slovakia

Kosice, , Slovakia

Kralovsky Chlmec, , Slovakia

Moldava Nad Bodvou, , Slovakia

Pezinok, , Slovakia

Povazska Bystrica, , Slovakia

Presov, , Slovakia

Roznava, , Slovakia

Sturovo, , Slovakia

Trebisov, , Slovakia

Trencin, , Slovakia

Bloemfontein, , South Africa

Cape Town, , South Africa

Johannesburg, , South Africa

Parow, , South Africa

Rivonia, , South Africa

Umhlanga Rocks Suburb, , South Africa

Alcorcón, , Spain

Barcelona, , Spain

Granada, , Spain

Madrid, , Spain

Majadahonda, , Spain

Málaga, , Spain

Olot, , Spain

San Sebastián De Los Reyes, , Spain

Sevilla, , Spain

Valencia, , Spain

Goteborg, , Sweden

Helsingborg, , Sweden

Kristianstad, , Sweden

Malmö, , Sweden

Skövde, , Sweden

Adana, , Turkey

Ankara, , Turkey

Antalya, , Turkey

Aydin, , Turkey

Bursa, , Turkey

Eskisehir, , Turkey

Istanbul, , Turkey

Izmit, , Turkey

Kutahya, , Turkey

Samsun, , Turkey

Sivas, , Turkey

Dnipro, , Ukraine

Ivano Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Ternopil, , Ukraine

Patients applied

0 patients applied

Trial Officials

Clinical Sciences & Operations

Study Director

Sanofi

Timeline

First submit

April 05, 2018

Trial launched

April 27, 2018

Trial updated

September 16, 2021

Estimated completion

Not reported

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