Effect of Efpeglenatide on Cardiovascular Outcomes

Type 2 Diabetes Mellitus Clinical Trial

— AMPLITUDE-O  

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03496298
• Other study ID #: EFC14828
• Secondary ID: 2017-002954-35U1
• Status: Terminated
• Phase: Phase 3
• Start date: April 27, 2018
• Est. completion date: December 10, 2020

Study information

• Verified date: August 2021
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4076
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Efpeglenatide (SAR439977)
Pharmaceutical form: Solution for injection, Route of administration: SC
• Placebo
Pharmaceutical form: Solution for injection Route of administration: SC

Locations

Country	Name	City	State
Argentina	Investigational Site Number 0320009	Buenos Aires
Argentina	Investigational Site Number 0320002	Caba
Argentina	Investigational Site Number 0320005	Caba
Argentina	Investigational Site Number 0320010	Caba
Argentina	Investigational Site Number 0320013	Caba
Argentina	Investigational Site Number 0320001	Capital Federal
Argentina	Investigational Site Number 0320008	Capital Federal
Argentina	Investigational Site Number 0320004	Corrientes
Argentina	Investigational Site Number 0320012	Corrientes
Argentina	Investigational Site Number 0320011	Godoy Cruz
Argentina	Investigational Site Number 0320007	Mar Del Plata
Argentina	Investigational Site Number 0320006	Merlo
Argentina	Investigational Site Number 0320015	Rosario
Argentina	Investigational Site Number 0320017	Rosario
Argentina	Investigational Site Number 0320003	Salta
Argentina	Investigational Site Number 0320018	Salta
Argentina	Investigational Site Number 0320016	San Isidro
Argentina	Investigational Site Number 0320014	Santa Rosa
Bulgaria	Investigational Site Number 1000011	Blagoevgrad
Bulgaria	Investigational Site Number 1000014	Dimitrovgrad
Bulgaria	Investigational Site Number 1000017	Gabrovo
Bulgaria	Investigational Site Number 1000007	Kazanlak
Bulgaria	Investigational Site Number 1000013	Kyustendil
Bulgaria	Investigational Site Number 1000010	Lovech
Bulgaria	Investigational Site Number 1000002	Plovdiv
Bulgaria	Investigational Site Number 1000008	Plovdiv
Bulgaria	Investigational Site Number 1000012	Ruse
Bulgaria	Investigational Site Number 1000001	Sofia
Bulgaria	Investigational Site Number 1000003	Sofia
Bulgaria	Investigational Site Number 1000005	Sofia
Bulgaria	Investigational Site Number 1000006	Stara Zagora
Bulgaria	Investigational Site Number 1000009	Varna
Bulgaria	Investigational Site Number 1000016	Yambol
Canada	Investigational Site Number 1240001	Barrie
Canada	Investigational Site Number 1240002	Brampton
Canada	Investigational Site Number 1240018	Burlington
Canada	Investigational Site Number 1240021	Burlington
Canada	Investigational Site Number 1240007	Calgary
Canada	Investigational Site Number 1240020	Calgary
Canada	Investigational Site Number 1240024	Chicoutimi
Canada	Investigational Site Number 1240004	Concord
Canada	Investigational Site Number 1240005	Etobicoke
Canada	Investigational Site Number 1240011	Levis
Canada	Investigational Site Number 1240025	London
Canada	Investigational Site Number 1240028	London
Canada	Investigational Site Number 1240029	Mirabel
Canada	Investigational Site Number 1240008	Montreal
Canada	Investigational Site Number 1240014	Montreal
Canada	Investigational Site Number 1240017	Montreal
Canada	Investigational Site Number 1240023	Montreal
Canada	Investigational Site Number 1240031	Montreal
Canada	Investigational Site Number 1240015	Oakville
Canada	Investigational Site Number 1240012	Oshawa
Canada	Investigational Site Number 1240030	Ottawa
Canada	Investigational Site Number 1240027	Peterborough
Canada	Investigational Site Number 1240016	Pointe-Claire
Canada	Investigational Site Number 1240010	Quebec
Canada	Investigational Site Number 1240019	Red Deer
Canada	Investigational Site Number 1240006	Sherbrooke
Canada	Investigational Site Number 1240022	Sudbury
Canada	Investigational Site Number 1240013	Toronto
Canada	Investigational Site Number 1240003	Vancouver
Canada	Investigational Site Number 1240026	Victoria
Canada	Investigational Site Number 1240009	Victoriaville
Chile	Investigational Site Number 1520012	Antofagasta
Chile	Investigational Site Number 1520008	Concepción
Chile	Investigational Site Number 1520001	Santiago
Chile	Investigational Site Number 1520002	Santiago
Chile	Investigational Site Number 1520003	Santiago
Chile	Investigational Site Number 1520005	Santiago
Chile	Investigational Site Number 1520007	Santiago
Chile	Investigational Site Number 1520010	Santiago
Chile	Investigational Site Number 1520011	Santiago
Chile	Investigational Site Number 1520013	Santiago
Chile	Investigational Site Number 1520014	Santiago
Chile	Investigational Site Number 1520006	Temuco
Chile	Investigational Site Number 1520004	Viña Del Mar
Denmark	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
Estonia	Investigational Site Number 2330002	Pärnu
Estonia	Investigational Site Number 2330001	Tallinn
Estonia	Investigational Site Number 2330003	Viljandi
Finland	Investigational Site Number 2460002	Helsinki
Finland	Investigational Site Number 2460001	Jyväskylä
Finland	Investigational Site Number 2460003	Kuopio
Finland	Investigational Site Number 2460004	Oulu
Germany	Investigational Site Number 2760006	Berlin
Germany	Investigational Site Number 2760009	Berlin
Germany	Investigational Site Number 2760004	Essen
Germany	Investigational Site Number 2760008	Frankfurt Am Main
Germany	Investigational Site Number 2760005	Münster
Germany	Investigational Site Number 2760003	Oldenburg In Holstein
Germany	Investigational Site Number 2760002	Pirna
Germany	Investigational Site Number 2760007	Rotenburg An Der Fulda
Hungary	Investigational Site Number 3480012	Balatonfüred
Hungary	Investigational Site Number 3480001	Budapest
Hungary	Investigational Site Number 3480003	Budapest
Hungary	Investigational Site Number 3480005	Budapest
Hungary	Investigational Site Number 3480006	Budapest
Hungary	Investigational Site Number 3480011	Budapest
Hungary	Investigational Site Number 3480002	Debrecen
Hungary	Investigational Site Number 3480009	Komárom
Hungary	Investigational Site Number 3480008	Mosonmagyaróvár
Hungary	Investigational Site Number 3480007	Székesfehérvár
Hungary	Investigational Site Number 3480004	Zalaegerszeg
India	Investigational Site Number 3560001	Belgaum
India	Investigational Site Number 3560002	Gurgaon
India	Investigational Site Number 3560007	Kolkata
India	Investigational Site Number 3560006	Lucknow
India	Investigational Site Number 3560003	New Delhi
India	Investigational Site Number 3560009	New Delhi
India	Investigational Site Number 3560005	Pune
India	Investigational Site Number 3560010	Pune
India	Investigational Site Number 3560004	Vellore
Italy	Investigational Site Number 3800006	Catania
Italy	Investigational Site Number 3800003	Catanzaro
Italy	Investigational Site Number 3800005	Catanzaro
Italy	Investigational Site Number 3800002	Chieti
Italy	Investigational Site Number 3800001	Milano
Italy	Investigational Site Number 3800004	Roma
Korea, Republic of	Investigational Site Number 4100007	Busan
Korea, Republic of	Investigational Site Number 4100006	Guri-si	Gyeonggi-Do
Korea, Republic of	Investigational Site Number 4100001	Seoul
Korea, Republic of	Investigational Site Number 4100002	Seoul
Korea, Republic of	Investigational Site Number 4100003	Seoul
Korea, Republic of	Investigational Site Number 4100005	Seoul
Korea, Republic of	Investigational Site Number 4100009	Seoul
Korea, Republic of	Investigational Site Number 4100010	Seoul
Korea, Republic of	Investigational Site Number 4100011	Seoul
Korea, Republic of	Investigational Site Number 4100008	Wonju
Latvia	Investigational Site Number 4280004	Daugavpils
Latvia	Investigational Site Number 4280002	Liepaja
Latvia	Investigational Site Number 4280001	Riga
Latvia	Investigational Site Number 4280003	Sigulda
Lithuania	Investigational Site Number 4400001	Kaunas
Lithuania	Investigational Site Number 4400002	Kaunas
Lithuania	Investigational Site Number 4400003	Klaipeda
Lithuania	Investigational Site Number 4400004	Vilnius
Mexico	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
Mexico	Investigational Site Number 4840002	Cuernavaca
Mexico	Investigational Site Number 4840015	Durango
Mexico	Investigational Site Number 4840016	Durango
Mexico	Investigational Site Number 4840003	Guadalajara
Mexico	Investigational Site Number 4840005	Guadalajara
Mexico	Investigational Site Number 4840006	Guadalajara
Mexico	Investigational Site Number 4840001	Monterrey
Mexico	Investigational Site Number 4840010	Monterrey
Mexico	Investigational Site Number 4840011	Monterrey
Norway	Investigational Site Number 5780002	Hamar
Norway	Investigational Site Number 5780001	Oslo
Norway	Investigational Site Number 5780003	Stavanger
Peru	Investigational Site Number 6040001	Lima
Peru	Investigational Site Number 6040003	Lima
Peru	Investigational Site Number 6040004	Lima
Peru	Investigational Site Number 6040005	Lima
Peru	Investigational Site Number 6040006	Lima
Peru	Investigational Site Number 6040007	Lima
Peru	Investigational Site Number 6040002	Piura
Poland	Investigational Site Number 6160017	Bialystok
Poland	Investigational Site Number 6160015	Bydgoszcz
Poland	Investigational Site Number 6160018	Bydgoszcz
Poland	Investigational Site Number 6160012	Gdansk
Poland	Investigational Site Number 6160016	Gdansk
Poland	Investigational Site Number 6160005	Katowice
Poland	Investigational Site Number 6160006	Plock
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	Warszawa
Poland	Investigational Site Number 6160004	Wroclaw
Romania	Investigational Site Number 6420007	Bacau
Romania	Investigational Site Number 6420001	Brasov
Romania	Investigational Site Number 6420011	Brasov
Romania	Investigational Site Number 6420009	Bucuresti
Romania	Investigational Site Number 6420005	Oradea
Romania	Investigational Site Number 6420010	Oradea
Romania	Investigational Site Number 6420012	Oradea
Romania	Investigational Site Number 6420008	Ploiesti
Romania	Investigational Site Number 6420002	Târgu-Mures
Romania	Investigational Site Number 6420003	Târgu-Mures
Russian Federation	Investigational Site Number 6430018	Kaliningrad
Russian Federation	Investigational Site Number 6430014	Kazan
Russian Federation	Investigational Site Number 6430001	Kemerovo
Russian Federation	Investigational Site Number 6430017	Krasnogorsk
Russian Federation	Investigational Site Number 6430002	Moscow
Russian Federation	Investigational Site Number 6430004	Moscow
Russian Federation	Investigational Site Number 6430005	Moscow
Russian Federation	Investigational Site Number 6430015	Moscow
Russian Federation	Investigational Site Number 6430009	Novosibirsk
Russian Federation	Investigational Site Number 6430019	Novosibirsk
Russian Federation	Investigational Site Number 6430006	Saint-Petersburg
Russian Federation	Investigational Site Number 6430012	Saint-Petersburg
Russian Federation	Investigational Site Number 6430003	Saratov
Russian Federation	Investigational Site Number 6430020	Saratov
Russian Federation	Investigational Site Number 6430010	St-Petersburg
Russian Federation	Investigational Site Number 6430011	St-Petersburg
Russian Federation	Investigational Site Number 6430013	St. Petersburg
Russian Federation	Investigational Site Number 6430016	St. Petersburg
Serbia	Investigational Site Number 6880001	Belgrade
Serbia	Investigational Site Number 6880002	Belgrade
Serbia	Investigational Site Number 6880003	Belgrade
Serbia	Investigational Site Number 6880005	Belgrade
Serbia	Investigational Site Number 6880004	Kragujevac
Serbia	Investigational Site Number 6880006	Novi Sad
Slovakia	Investigational Site Number 7030007	Bratislava
Slovakia	Investigational Site Number 7030001	Kosice
Slovakia	Investigational Site Number 7030004	Kosice
Slovakia	Investigational Site Number 7030003	Kralovsky Chlmec
Slovakia	Investigational Site Number 7030009	Moldava Nad Bodvou
Slovakia	Investigational Site Number 7030010	Pezinok
Slovakia	Investigational Site Number 7030006	Povazska Bystrica
Slovakia	Investigational Site Number 7030005	Presov
Slovakia	Investigational Site Number 7030008	Roznava
Slovakia	Investigational Site Number 7030011	Sturovo
Slovakia	Investigational Site Number 7030002	Trebisov
Slovakia	Investigational Site Number 7030012	Trencin
South Africa	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 7100001	Johannesburg
South Africa	Investigational Site Number 7100003	Johannesburg
South Africa	Investigational Site Number 7100002	Parow
South Africa	Investigational Site Number 7100004	Rivonia
South Africa	Investigational Site Number 7100008	Umhlanga Rocks Suburb
Spain	Investigational Site Number 7240008	Alcorcón
Spain	Investigational Site Number 7240002	Barcelona
Spain	Investigational Site Number 7240009	Barcelona
Spain	Investigational Site Number 7240007	Granada
Spain	Investigational Site Number 7240001	Madrid
Spain	Investigational Site Number 7240010	Madrid
Spain	Investigational Site Number 7240006	Majadahonda
Spain	Investigational Site Number 7240011	Málaga
Spain	Investigational Site Number 7240005	Olot
Spain	Investigational Site Number 7240003	San Sebastián De Los Reyes
Spain	Investigational Site Number 7240013	Sevilla
Spain	Investigational Site Number 7240004	Valencia
Spain	Investigational Site Number 7240014	Valencia
Sweden	Investigational Site Number 7520006	Goteborg
Sweden	Investigational Site Number 7520003	Helsingborg
Sweden	Investigational Site Number 7520004	Kristianstad
Sweden	Investigational Site Number 7520002	Malmö
Sweden	Investigational Site Number 7520005	Skövde
Sweden	Investigational Site Number 7520001	Stockholm
Turkey	Investigational Site Number 7920005	Adana
Turkey	Investigational Site Number 7920010	Ankara
Turkey	Investigational Site Number 7920012	Antalya
Turkey	Investigational Site Number 7920015	Aydin
Turkey	Investigational Site Number 7920002	Bursa
Turkey	Investigational Site Number 7920013	Eskisehir
Turkey	Investigational Site Number 7920001	Istanbul
Turkey	Investigational Site Number 7920006	Istanbul
Turkey	Investigational Site Number 7920011	Izmit
Turkey	Investigational Site Number 7920014	Kutahya
Turkey	Investigational Site Number 7920007	Samsun
Turkey	Investigational Site Number 7920009	Sivas
Ukraine	Investigational Site Number 8040006	Dnipro
Ukraine	Investigational Site Number 8040001	Ivano-Frankivsk
Ukraine	Investigational Site Number 8040009	Ivano-Frankivsk
Ukraine	Investigational Site Number 8040002	Kharkiv
Ukraine	Investigational Site Number 8040003	Kharkiv
Ukraine	Investigational Site Number 8040007	Kiev
Ukraine	Investigational Site Number 8040008	Kyiv
Ukraine	Investigational Site Number 8040004	Ternopil
Ukraine	Investigational Site Number 8040005	Vinnytsya
United States	Investigational Site Number 8400034	Alexandria	Louisiana
United States	Investigational Site Number 8400095	Arlington Heights	Illinois
United States	Investigational Site Number 8400067	Beaver	Pennsylvania
United States	Investigational Site Number 8400072	Bend	Oregon
United States	Investigational Site Number 8400022	Beverly Hills	California
United States	Investigational Site Number 8400071	Billings	Montana
United States	Investigational Site Number 8400018	Bronx	New York
United States	Investigational Site Number 8400070	Chicago	Illinois
United States	Investigational Site Number 8400031	Columbus	Ohio
United States	Investigational Site Number 8400065	Concord	California
United States	Investigational Site Number 8400055	Corpus Christi	Texas
United States	Investigational Site Number 8400036	Crystal Lake	Illinois
United States	Investigational Site Number 8400097	Dallas	Texas
United States	Investigational Site Number 8400088	El Paso	Texas
United States	Investigational Site Number 8400064	Englewood	Colorado
United States	Investigational Site Number 8400029	Fargo	North Dakota
United States	Investigational Site Number 8400001	Flint	Michigan
United States	Investigational Site Number 8400061	Flint	Michigan
United States	Investigational Site Number 8400058	Fort Worth	Texas
United States	Investigational Site Number 8400014	Gilbert	Arizona
United States	Investigational Site Number 8400028	Great Falls	Montana
United States	Investigational Site Number 8400060	Greenbrae	California
United States	Investigational Site Number 8400076	Greenville	North Carolina
United States	Investigational Site Number 8400015	Greer	South Carolina
United States	Investigational Site Number 8400019	Hamden	Connecticut
United States	Investigational Site Number 8400091	Hialeah	Florida
United States	Investigational Site Number 8400040	Hollywood	Florida
United States	Investigational Site Number 8400069	Houston	Texas
United States	Investigational Site Number 8400089	Houston	Texas
United States	Investigational Site Number 8400073	Hudson	Florida
United States	Investigational Site Number 8400081	Idaho Falls	Idaho
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 8400086	Kalispell	Montana
United States	Investigational Site Number 8400037	Las Vegas	Nevada
United States	Investigational Site Number 8400084	Long Beach	California
United States	Investigational Site Number 8400078	Lorain	Ohio
United States	Investigational Site Number 8400002	Los Gatos	California
United States	Investigational Site Number 8400006	Macon	Georgia
United States	Investigational Site Number 8400049	Manitowoc	Wisconsin
United States	Investigational Site Number 8400016	Memphis	Tennessee
United States	Investigational Site Number 8400027	Miami	Florida
United States	Investigational Site Number 8400051	Miami	Florida
United States	Investigational Site Number 8400079	Monroe	Louisiana
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 8400063	Murrells Inlet	South Carolina
United States	Investigational Site Number 8400009	Nashville	Tennessee
United States	Investigational Site Number 8400030	New Albany	Indiana
United States	Investigational Site Number 8400013	New Orleans	Louisiana
United States	Investigational Site Number 8400041	New Port Richey	Florida
United States	Investigational Site Number 8400052	Norfolk	Virginia
United States	Investigational Site Number 8400085	Northridge	California
United States	Investigational Site Number 8400059	Ormond Beach	Florida
United States	Investigational Site Number 8400077	Owensboro	Kentucky
United States	Investigational Site Number 8400047	Oxon Hill	Maryland
United States	Investigational Site Number 8400043	Paris	Kentucky
United States	Investigational Site Number 8400096	Philadelphia	Pennsylvania
United States	Investigational Site Number 8400021	Pittsburgh	Pennsylvania
United States	Investigational Site Number 8400082	Pomona	California
United States	Investigational Site Number 8400044	Rapid City	South Dakota
United States	Investigational Site Number 8400087	Raritan	New Jersey
United States	Investigational Site Number 8400092	Richmond	Texas
United States	Investigational Site Number 8400008	Roswell	Georgia
United States	Investigational Site Number 8400025	Sacramento	California
United States	Investigational Site Number 8400045	Saint Louis	Missouri
United States	Investigational Site Number 8400024	Saint Paul	Minnesota
United States	Investigational Site Number 8400039	Salt Lake City	Utah
United States	Investigational Site Number 8400032	Sheffield	Alabama
United States	Investigational Site Number 8400056	Staten Island	New York
United States	Investigational Site Number 8400012	Surprise	Arizona
United States	Investigational Site Number 8400074	Topeka	Kansas
United States	Investigational Site Number 8400005	Troy	Michigan
United States	Investigational Site Number 8400010	Troy	Michigan
United States	Investigational Site Number 8400046	Tucson	Arizona
United States	Investigational Site Number 8400033	Waco	Texas
United States	Investigational Site Number 8400023	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Chile,  Denmark,  Estonia,  Finland,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis	All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Secondary	Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis	All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Secondary	Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event	All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Secondary	Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint	Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, as measured in mg of albumin to grams of creatinine, or >33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.	From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)