Clinical trial NCT03496298: Effect of Efpeglenatide on Cardiovascular Outcomes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2018-04-12
Enrollment: 4076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Secondary outcomes:
measure: Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis
timeFrame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
measure: 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
timeFrame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
measure: Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint
timeFrame: From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Investigational Site Number 8400032
state: Alabama
city: Gilbert
country: United States
facility: Investigational Site Number 8400014
state: Arizona
city: Surprise
country: United States
facility: Investigational Site Number 8400012
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 8400046
state: Arizona
city: Beverly Hills
country: United States
facility: Investigational Site Number 8400022
state: California
city: Concord
country: United States
facility: Investigational Site Number 8400065
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 8400060
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 8400084
state: California
city: Los Gatos
country: United States
facility: Investigational Site Number 8400002
state: California
city: Northridge
country: United States
facility: Investigational Site Number 8400085
state: California
city: Pomona
country: United States
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state: California
city: Sacramento
country: United States
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state: California
city: Englewood
country: United States
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state: Colorado
city: Hamden
country: United States
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state: Connecticut
city: Waterbury
country: United States
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state: Connecticut
city: Hialeah
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: Hudson
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
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country: United States
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state: Florida
city: Miami
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state: Florida
city: New Port Richey
country: United States
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state: Florida
city: Ormond Beach
country: United States
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state: Florida
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country: United States
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state: Georgia
city: Roswell
country: United States
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
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country: United States
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state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Crystal Lake
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state: Illinois
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state: Indiana
city: Topeka
country: United States
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state: Kansas
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country: United States
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state: Kentucky
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country: United States
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state: Kentucky
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country: United States
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state: Louisiana
city: Monroe
country: United States
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state: Louisiana
city: New Orleans
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state: Maryland
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city: Flint
country: United States
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country: United States
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state: Montana
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state: New Jersey
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country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
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state: North Carolina
city: Fargo
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state: North Dakota
city: Columbus
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state: Ohio
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state: Ohio
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state: Oregon
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
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state: Pennsylvania
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state: Tennessee
city: Nashville
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state: Tennessee
city: Corpus Christi
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: El Paso
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state: Texas
city: Fort Worth
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state: Texas
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state: Texas
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state: Texas
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state: Texas
city: Waco
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state: Utah
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country: United States
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state: Virginia
city: Manitowoc
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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country: Argentina
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city: Blagoevgrad
country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Canada
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country: Chile
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country: Chile
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city: Warszawa
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country: Romania
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city: Brasov
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city: Bucuresti
country: Romania
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country: Romania
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city: Oradea
country: Romania
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city: Oradea
country: Romania
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city: Ploiesti
country: Romania
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city: Târgu-Mureş
country: Romania
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city: Târgu-Mureş
country: Romania
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city: Kaliningrad
country: Russian Federation
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city: Kazan
country: Russian Federation
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country: Russian Federation
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city: Krasnogorsk
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430019
city: Saint-Petersburg
country: Russian Federation
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city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430012
city: Saratov
country: Russian Federation
facility: Investigational Site Number 6430003
city: Saratov
country: Russian Federation
facility: Investigational Site Number 6430020
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430010
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430011
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 6430013
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 6430016
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880001
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880002
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880003
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880005
city: Kragujevac
country: Serbia
facility: Investigational Site Number 6880004
city: Novi Sad
country: Serbia
facility: Investigational Site Number 6880006
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7030007
city: Kosice
country: Slovakia
facility: Investigational Site Number 7030001
city: Kosice
country: Slovakia
facility: Investigational Site Number 7030004
city: Kralovsky Chlmec
country: Slovakia
facility: Investigational Site Number 7030003
city: Moldava Nad Bodvou
country: Slovakia
facility: Investigational Site Number 7030009
city: Pezinok
country: Slovakia
facility: Investigational Site Number 7030010
city: Povazska Bystrica
country: Slovakia
facility: Investigational Site Number 7030006
city: Presov
country: Slovakia
facility: Investigational Site Number 7030005
city: Roznava
country: Slovakia
facility: Investigational Site Number 7030008
city: Sturovo
country: Slovakia
facility: Investigational Site Number 7030011
city: Trebisov
country: Slovakia
facility: Investigational Site Number 7030002
city: Trencin
country: Slovakia
facility: Investigational Site Number 7030012
city: Bloemfontein
country: South Africa
facility: Investigational Site Number 7100007
city: Cape Town
country: South Africa
facility: Investigational Site Number 7100005
city: Cape Town
country: South Africa
facility: Investigational Site Number 7100006
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7100003
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7100001
city: Parow
country: South Africa
facility: Investigational Site Number 7100002
city: Rivonia
country: South Africa
facility: Investigational Site Number 7100004
city: Umhlanga Rocks Suburb
country: South Africa
facility: Investigational Site Number 7100008
city: Alcorcón
country: Spain
facility: Investigational Site Number 7240008
city: Barcelona
country: Spain
facility: Investigational Site Number 7240002
city: Barcelona
country: Spain
facility: Investigational Site Number 7240009
city: Granada
country: Spain
facility: Investigational Site Number 7240007
city: Madrid
country: Spain
facility: Investigational Site Number 7240010
city: Madrid
country: Spain
facility: Investigational Site Number 7240001
city: Majadahonda
country: Spain
facility: Investigational Site Number 7240006
city: Málaga
country: Spain
facility: Investigational Site Number 7240011
city: Olot
country: Spain
facility: Investigational Site Number 7240005
city: San Sebastián De Los Reyes
country: Spain
facility: Investigational Site Number 7240003
city: Sevilla
country: Spain
facility: Investigational Site Number 7240013
city: Valencia
country: Spain
facility: Investigational Site Number 7240004
city: Valencia
country: Spain
facility: Investigational Site Number 7240014
city: Goteborg
country: Sweden
facility: Investigational Site Number 7520006
city: Helsingborg
country: Sweden
facility: Investigational Site Number 7520003
city: Kristianstad
country: Sweden
facility: Investigational Site Number 7520004
city: Malmö
country: Sweden
facility: Investigational Site Number 7520002
city: Skövde
country: Sweden
facility: Investigational Site Number 7520005
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520001
city: Adana
country: Turkey
facility: Investigational Site Number 7920005
city: Ankara
country: Turkey
facility: Investigational Site Number 7920010
city: Antalya
country: Turkey
facility: Investigational Site Number 7920012
city: Aydin
country: Turkey
facility: Investigational Site Number 7920015
city: Bursa
country: Turkey
facility: Investigational Site Number 7920002
city: Eskisehir
country: Turkey
facility: Investigational Site Number 7920013
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920006
city: Izmit
country: Turkey
facility: Investigational Site Number 7920011
city: Kutahya
country: Turkey
facility: Investigational Site Number 7920014
city: Samsun
country: Turkey
facility: Investigational Site Number 7920007
city: Sivas
country: Turkey
facility: Investigational Site Number 7920009
city: Dnipro
country: Ukraine
facility: Investigational Site Number 8040006
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 8040009
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 8040001
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040003
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040002
city: Kiev
country: Ukraine
facility: Investigational Site Number 8040007
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040008
city: Ternopil
country: Ukraine
facility: Investigational Site Number 8040004
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 8040005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.