Effect of Efpeglenatide on Cardiovascular Outcomes

NCT03496298 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC148282017-002954-35U1111-1186-2533
• Study Type: interventional
• Target: 4,076
• Locations: 26 countries
• Sites: 344

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis

  From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

• 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

  From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

• Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint

  From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Efpeglenatide 4 mg

EXPERIMENTAL

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

Drug: Efpeglenatide (SAR439977)

Efpeglenatide 6 mg

EXPERIMENTAL

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.

Drug: Efpeglenatide (SAR439977)

Interventions

Efpeglenatide (SAR439977) DRUG

Pharmaceutical form: Solution for injection, Route of administration: SC

Efpeglenatide 4 mg; Efpeglenatide 6 mg

Placebo DRUG

Pharmaceutical form: Solution for injection Route of administration: SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Hanmi Pharmaceutical Company Limited: collaborator

Study Sites (353)

Investigational Site Number 8400032

Sheffield, Alabama, 35660, United States

Location

Investigational Site Number 8400014

Gilbert, Arizona, 85295, United States

Location

Investigational Site Number 8400012

Surprise, Arizona, 85374, United States

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Investigational Site Number 8400046

Tucson, Arizona, 85745, United States

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Investigational Site Number 8400022

Beverly Hills, California, 90211, United States

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Investigational Site Number 8400065

Concord, California, 94520, United States

Location

Investigational Site Number 8400060

Greenbrae, California, 94904, United States

Location

Investigational Site Number 8400084

Long Beach, California, 90807, United States

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Investigational Site Number 8400002

Los Gatos, California, 95032, United States

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Investigational Site Number 8400085

Northridge, California, 91325, United States

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Investigational Site Number 8400082

Pomona, California, 91767, United States

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Investigational Site Number 8400025

Sacramento, California, 95821, United States

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Investigational Site Number 8400064

Englewood, Colorado, 80113, United States

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Investigational Site Number 8400019

Hamden, Connecticut, 06517, United States

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Investigational Site Number 8400023

Waterbury, Connecticut, 06708-3346, United States

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Investigational Site Number 8400091

Hialeah, Florida, 33012, United States

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Investigational Site Number 8400040

Hollywood, Florida, 33024, United States

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Investigational Site Number 8400073

Hudson, Florida, 34667, United States

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Investigational Site Number 8400011

Jacksonville, Florida, 32204, United States

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Investigational Site Number 8400017

Jacksonville, Florida, 32204, United States

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Investigational Site Number 8400042

Jacksonville, Florida, 32277, United States

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Investigational Site Number 8400027

Miami, Florida, 33126, United States

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Investigational Site Number 8400051

Miami, Florida, 33136, United States

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Investigational Site Number 8400041

New Port Richey, Florida, 34652, United States

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Investigational Site Number 8400059

Ormond Beach, Florida, 32174, United States

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Investigational Site Number 8400006

Macon, Georgia, 31210-1359, United States

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Investigational Site Number 8400008

Roswell, Georgia, 30076, United States

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Investigational Site Number 8400081

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 8400095

Arlington Heights, Illinois, 60005, United States

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Investigational Site Number 8400070

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 8400036

Crystal Lake, Illinois, 60012, United States

Location

Investigational Site Number 8400030

New Albany, Indiana, 46113, United States

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Investigational Site Number 8400074

Topeka, Kansas, 66606, United States

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Investigational Site Number 8400077

Owensboro, Kentucky, 42303, United States

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Investigational Site Number 8400043

Paris, Kentucky, 40361, United States

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Investigational Site Number 8400034

Alexandria, Louisiana, 71301, United States

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Investigational Site Number 8400079

Monroe, Louisiana, 71203, United States

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Investigational Site Number 8400013

New Orleans, Louisiana, 70112, United States

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Investigational Site Number 8400047

Oxon Hill, Maryland, 20745, United States

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Investigational Site Number 8400001

Flint, Michigan, 48504, United States

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Investigational Site Number 8400061

Flint, Michigan, 48532-3447, United States

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Investigational Site Number 8400010

Troy, Michigan, 48085, United States

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Investigational Site Number 8400005

Troy, Michigan, 48098, United States

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Investigational Site Number 8400024

Saint Paul, Minnesota, 55102, United States

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Investigational Site Number 8400045

St Louis, Missouri, 63136, United States

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Investigational Site Number 8400071

Billings, Montana, 59103, United States

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Investigational Site Number 8400028

Great Falls, Montana, 59405-4507, United States

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Investigational Site Number 8400086

Kalispell, Montana, 59901, United States

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Investigational Site Number 8400037

Las Vegas, Nevada, 89128, United States

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Investigational Site Number 8400087

Raritan, New Jersey, 08869, United States

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Investigational Site Number 8400056

Staten Island, New York, 10301, United States

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Investigational Site Number 8400018

The Bronx, New York, 00000, United States

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Investigational Site Number 8400076

Greenville, North Carolina, 27834-5704, United States

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Investigational Site Number 8400007

Morehead City, North Carolina, 28557, United States

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Investigational Site Number 8400093

Morehead City, North Carolina, 28557, United States

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Investigational Site Number 8400094

Morganton, North Carolina, 28655, United States

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Investigational Site Number 8400029

Fargo, North Dakota, 58104, United States

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Investigational Site Number 8400031

Columbus, Ohio, 43203, United States

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Investigational Site Number 8400078

Lorain, Ohio, 44053, United States

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Investigational Site Number 8400072

Bend, Oregon, 97702, United States

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Investigational Site Number 8400067

Beaver, Pennsylvania, 15009-1957, United States

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Investigational Site Number 8400096

Philadelphia, Pennsylvania, 19107, United States

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Investigational Site Number 8400021

Pittsburgh, Pennsylvania, 15212, United States

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Investigational Site Number 8400015

Greer, South Carolina, 29651, United States

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Investigational Site Number 8400063

Murrells Inlet, South Carolina, 29576, United States

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Investigational Site Number 8400044

Rapid City, South Dakota, 57702, United States

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Investigational Site Number 8400016

Memphis, Tennessee, 38163, United States

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Investigational Site Number 8400009

Nashville, Tennessee, 37203, United States

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Investigational Site Number 8400055

Corpus Christi, Texas, 78814, United States

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Investigational Site Number 8400097

Dallas, Texas, 75230, United States

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Investigational Site Number 8400088

El Paso, Texas, 79935, United States

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Investigational Site Number 8400058

Fort Worth, Texas, 76132, United States

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Investigational Site Number 8400069

Houston, Texas, 77004, United States

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Investigational Site Number 8400089

Houston, Texas, 77030, United States

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Investigational Site Number 8400092

Richmond, Texas, 77469, United States

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Investigational Site Number 8400033

Waco, Texas, 76710, United States

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Investigational Site Number 8400039

Salt Lake City, Utah, 84102, United States

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Investigational Site Number 8400052

Norfolk, Virginia, 23510, United States

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Investigational Site Number 8400049

Manitowoc, Wisconsin, 54220, United States

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Investigational Site Number 0320009

Buenos Aires, 1430, Argentina

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Investigational Site Number 0320002

Caba, 1120, Argentina

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Investigational Site Number 0320013

Caba, 1425DES, Argentina

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Investigational Site Number 0320010

Caba, 1425, Argentina

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Investigational Site Number 0320005

Caba, C1119ACN, Argentina

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Investigational Site Number 0320008

Capital Federal, C1056ABJ, Argentina

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Investigational Site Number 0320001

Capital Federal, C1179AAB, Argentina

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Investigational Site Number 0320004

Corrientes, W3400AMZ, Argentina

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Investigational Site Number 0320012

Corrientes, W3410AVV, Argentina

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Investigational Site Number 0320011

Godoy Cruz, M5501ARP, Argentina

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Investigational Site Number 0320007

Mar del Plata, B7600FZN, Argentina

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Investigational Site Number 0320006

Merlo, B1722COV, Argentina

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Investigational Site Number 0320015

Rosario, 2000, Argentina

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Investigational Site Number 0320017

Rosario, S2002OJP, Argentina

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Investigational Site Number 0320003

Salta, 4400, Argentina

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Investigational Site Number 0320018

Salta, 4400, Argentina

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Investigational Site Number 0320016

San Isidro, B1642DCB, Argentina

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Investigational Site Number 0320014

Santa Rosa, Argentina

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Investigational Site Number 1000011

Blagoevgrad, 2700, Bulgaria

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Investigational Site Number 1000014

Dimitrovgrad, Bulgaria

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Investigational Site Number 1000017

Gabrovo, 5300, Bulgaria

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Investigational Site Number 1000007

Kazanlak, 6100, Bulgaria

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Investigational Site Number 1000013

Kyustendil, Bulgaria

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Investigational Site Number 1000010

Lovech, 5500, Bulgaria

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Investigational Site Number 1000008

Plovdiv, 4000, Bulgaria

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Investigational Site Number 1000002

Plovdiv, 4002, Bulgaria

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Investigational Site Number 1000012

Rousse, 7002, Bulgaria

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Investigational Site Number 1000003

Sofia, 1233, Bulgaria

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Investigational Site Number 1000001

Sofia, 1431, Bulgaria

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Investigational Site Number 1000005

Sofia, 1750, Bulgaria

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Investigational Site Number 1000006

Stara Zagora, 6000, Bulgaria

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Investigational Site Number 1000009

Varna, 9000, Bulgaria

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Investigational Site Number 1000016

Yambol, 8600, Bulgaria

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Investigational Site Number 1240001

Barrie, L4N 7L3, Canada

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Investigational Site Number 1240002

Brampton, L6S 0C6, Canada

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Investigational Site Number 1240018

Burlington, L7M 1K9, Canada

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Investigational Site Number 1240021

Burlington, L7R 1E2, Canada

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Investigational Site Number 1240007

Calgary, T2H 2G4, Canada

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Investigational Site Number 1240020

Calgary, T2V 4J2, Canada

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Investigational Site Number 1240024

Chicoutimi, G7H 7K9, Canada

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Investigational Site Number 1240004

Concord, L4K 4M2, Canada

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Investigational Site Number 1240005

Etobicoke, M9R 4E1, Canada

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Investigational Site Number 1240022

Greater Sudbury, P3E 4H5, Canada

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Investigational Site Number 1240011

Lévis, G6W 0M5, Canada

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Investigational Site Number 1240025

London, N5W 6A2, Canada

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Investigational Site Number 1240028

London, N6A 5R8, Canada

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Investigational Site Number 1240029

Mirabel, J7J 2K8, Canada

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Investigational Site Number 1240008

Montreal, H1M 1B1, Canada

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Investigational Site Number 1240031

Montreal, H1T 1C8, Canada

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Investigational Site Number 1240014

Montreal, H4A 2C6, Canada

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Investigational Site Number 1240023

Montreal, H4A 3T2, Canada

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Investigational Site Number 1240017

Montreal, H4N 2W2, Canada

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Investigational Site Number 1240015

Oakville, L6M 1M1, Canada

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Investigational Site Number 1240012

Oshawa, L1J 2K1, Canada

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Investigational Site Number 1240030

Ottawa, K2J 0V2, Canada

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Investigational Site Number 1240027

Peterborough, K9J 0B2, Canada

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Investigational Site Number 1240016

Pointe-Claire, H9R 4S3, Canada

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Investigational Site Number 1240010

Québec, G1N 4V3, Canada

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Investigational Site Number 1240019

Red Deer, T4N 6V7, Canada

Location

Investigational Site Number 1240006

Sherbrooke, J1L 0H8, Canada

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Investigational Site Number 1240013

Toronto, M4G 3E8, Canada

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Investigational Site Number 1240003

Vancouver, V5Y 3W2, Canada

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Investigational Site Number 1240026

Victoria, V8V 4A1, Canada

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Investigational Site Number 1240009

Victoriaville, G6P 6P6, Canada

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Investigational Site Number 1520012

Antofagasta, 1270013, Chile

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Investigational Site Number 1520008

Concepción, 4070566, Chile

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Investigational Site Number 1520013

Santiago, 7500571, Chile

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Investigational Site Number 1520002

Santiago, 7500710, Chile

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Investigational Site Number 1520007

Santiago, 7500710, Chile

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Investigational Site Number 1520011

Santiago, 7770086, Chile

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Investigational Site Number 1520010

Santiago, 8053095, Chile

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Investigational Site Number 1520001

Santiago, 8330336, Chile

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Investigational Site Number 1520003

Santiago, 8380456, Chile

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Investigational Site Number 1520014

Santiago, 8900132, Chile

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Investigational Site Number 1520005

Santiago, Chile

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Investigational Site Number 1520006

Temuco, 4813299, Chile

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Investigational Site Number 1520004

Viña del Mar, Chile

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Investigational Site Number 2080004

Aarhus N, 8200, Denmark

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Investigational Site Number 2080005

Esbjerg, 6700, Denmark

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Investigational Site Number 2080001

Hellerup, 2900, Denmark

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Investigational Site Number 2080003

Hvidovre, 2650, Denmark

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Investigational Site Number 2080002

København NV, 2400, Denmark

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Investigational Site Number 2330002

Pärnu, 80018, Estonia

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Investigational Site Number 2330001

Tallinn, 13419, Estonia

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Investigational Site Number 2330003

Viljandi, 71024, Estonia

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Investigational Site Number 2460002

Helsinki, 00100, Finland

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Investigational Site Number 2460001

Jyväskylä, 40620, Finland

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Investigational Site Number 2460003

Kuopio, 70100, Finland

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Investigational Site Number 2460004

Oulu, 90220, Finland

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Investigational Site Number 2760006

Berlin, 10437, Germany

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Investigational Site Number 2760009

Berlin, 12627, Germany

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Investigational Site Number 2760004

Essen, 45355, Germany

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Investigational Site Number 2760008

Frankfurt am Main, 60313, Germany

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Investigational Site Number 2760005

Münster, 48145, Germany

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Investigational Site Number 2760003

Oldenburg in Holstein, 23758, Germany

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Investigational Site Number 2760002

Pirna, 01796, Germany

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Investigational Site Number 2760007

Rotenburg an der Fulda, 36199, Germany

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Investigational Site Number 3480012

Balatonfüred, 8230, Hungary

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Investigational Site Number 3480011

Budapest, 1036, Hungary

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Investigational Site Number 3480003

Budapest, 1042, Hungary

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Investigational Site Number 3480005

Budapest, 1106, Hungary

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Investigational Site Number 3480001

Budapest, 1122, Hungary

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Investigational Site Number 3480006

Budapest, 1134, Hungary

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Investigational Site Number 3480002

Debrecen, 4032, Hungary

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Investigational Site Number 3480009

Komárom, 2900, Hungary

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Investigational Site Number 3480008

Mosonmagyaróvár, 9200, Hungary

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Investigational Site Number 3480007

Székesfehérvár, 8000, Hungary

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Investigational Site Number 3480004

Zalaegerszeg, 8900, Hungary

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Investigational Site Number 3560001

Belagavi, 590010, India

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Investigational Site Number 3560002

Gūrgaon, 122001, India

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Investigational Site Number 3560007

Kolkata, 700073, India

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Investigational Site Number 3560006

Lucknow, 226002, India

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Investigational Site Number 3560003

New Delhi, 110 029, India

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Investigational Site Number 3560009

New Delhi, 110060, India

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Investigational Site Number 3560010

Pune, 411001, India

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Investigational Site Number 3560005

Pune, 411010, India

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Investigational Site Number 3560004

Vellore, 632004, India

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Investigational Site Number 3800006

Catania, 95123, Italy

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Investigational Site Number 3800003

Catanzaro, 88100, Italy

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Investigational Site Number 3800005

Catanzaro, 88100, Italy

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Investigational Site Number 3800002

Chieti, 66013, Italy

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Investigational Site Number 3800001

Milan, 20132, Italy

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Investigational Site Number 3800004

Roma, 00133, Italy

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Investigational Site Number 4280004

Daugavpils, LV-5417, Latvia

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Investigational Site Number 4280002

Liepāja, LV3414, Latvia

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Investigational Site Number 4280001

Riga, LV-1011, Latvia

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Investigational Site Number 4280003

Sigulda, LV-2150, Latvia

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Investigational Site Number 4400001

Kaunas, 49449, Lithuania

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Investigational Site Number 4400002

Kaunas, 50161, Lithuania

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Investigational Site Number 4400003

Klaipėda, 92111, Lithuania

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Investigational Site Number 4400004

Vilnius, 08661, Lithuania

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Investigational Site Number 4840004

Actopan, 42500, Mexico

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Investigational Site Number 4840007

Aguascalientes, 20230, Mexico

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Investigational Site Number 4840009

Aguascalientes, 20230, Mexico

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Investigational Site Number 4840013

Aguascalientes, 20230, Mexico

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Investigational Site Number 4840014

Chihuahua City, 31000, Mexico

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Investigational Site Number 4840002

Cuernavaca, 62250, Mexico

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Investigational Site Number 4840016

Durango, 34000, Mexico

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Investigational Site Number 4840015

Durango, 34080, Mexico

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Investigational Site Number 4840006

Guadalajara, 44210, Mexico

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Investigational Site Number 4840003

Guadalajara, 44600, Mexico

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Investigational Site Number 4840005

Guadalajara, 44650, Mexico

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Investigational Site Number 4840011

Monterrey, 64020, Mexico

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Investigational Site Number 4840010

Monterrey, 64060, Mexico

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Investigational Site Number 4840001

Monterrey, 64460, Mexico

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Investigational Site Number 5780002

Hamar, 2317, Norway

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Investigational Site Number 5780001

Oslo, Norway

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Investigational Site Number 5780003

Stavanger, 4011, Norway

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Investigational Site Number 6040007

Lima, LIMA 01, Peru

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Investigational Site Number 6040004

Lima, LIMA 11, Peru

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Investigational Site Number 6040003

Lima, LIMA 27, Peru

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Investigational Site Number 6040006

Lima, LIMA 31, Peru

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Investigational Site Number 6040001

Lima, Peru

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Investigational Site Number 6040005

Lima, Peru

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Investigational Site Number 6040002

Piura, 20000, Peru

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Investigational Site Number 6160017

Bialystok, 15-404, Poland

Location

Investigational Site Number 6160018

Bydgoszcz, 80-095, Poland

Location

Investigational Site Number 6160015

Bydgoszcz, 85-090, Poland

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Investigational Site Number 6160016

Gdansk, 80-546, Poland

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Investigational Site Number 6160012

Gdansk, 80-858, Poland

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Investigational Site Number 6160005

Katowice, 40-530, Poland

Location

Investigational Site Number 6160006

Płock, 09-402, Poland

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Investigational Site Number 6160011

Skierniewice, 96-100, Poland

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Investigational Site Number 6160013

Skorzewo, 60-185, Poland

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Investigational Site Number 6160010

Szczecin, 70-506, Poland

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Investigational Site Number 6160007

Torun, 87-100, Poland

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Investigational Site Number 6160009

Torun, 87-100, Poland

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Investigational Site Number 6160014

Tychy, 43-100, Poland

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Investigational Site Number 6160002

Warsaw, 02-507, Poland

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Investigational Site Number 6160004

Wroclaw, 50-315, Poland

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Investigational Site Number 6420007

Bacau, 600154, Romania

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Investigational Site Number 6420001

Brasov, 500097, Romania

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Investigational Site Number 6420011

Brasov, 500365, Romania

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Investigational Site Number 6420009

Bucharest, 020475, Romania

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Investigational Site Number 6420012

Oradea, 410151, Romania

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Investigational Site Number 6420005

Oradea, 410159, Romania

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Investigational Site Number 6420010

Oradea, 410169, Romania

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Investigational Site Number 6420008

Ploieşti, 100561, Romania

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Investigational Site Number 6420002

Târgu Mureş, 540142, Romania

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Investigational Site Number 6420003

Târgu Mureş, 540142, Romania

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Investigational Site Number 6430018

Kaliningrad, 236035, Russia

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Investigational Site Number 6430014

Kazan', 420087, Russia

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Investigational Site Number 6430001

Kemerovo, 650002, Russia

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Investigational Site Number 6430017

Krasnogorsk, 143408, Russia

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Investigational Site Number 6430004

Moscow, 111539, Russia

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Investigational Site Number 6430005

Moscow, 117292, Russia

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Investigational Site Number 6430002

Moscow, 121374, Russia

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Investigational Site Number 6430015

Moscow, 121552, Russia

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Investigational Site Number 6430009

Novosibirsk, 630055, Russia

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Investigational Site Number 6430019

Novosibirsk, 630087, Russia

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Investigational Site Number 6430006

Saint Petersburg, 190013, Russia

Location

Investigational Site Number 6430010

Saint Petersburg, 193312, Russia

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Investigational Site Number 6430011

Saint Petersburg, 193312, Russia

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Investigational Site Number 6430013

Saint Petersburg, 194156, Russia

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Investigational Site Number 6430016

Saint Petersburg, 195067, Russia

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Investigational Site Number 6430012

Saint Petersburg, 198205, Russia

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Investigational Site Number 6430003

Saratov, 410028, Russia

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Investigational Site Number 6430020

Saratov, 410039, Russia

Location

Investigational Site Number 6880001

Belgrade, 11000, Serbia

Location

Investigational Site Number 6880002

Belgrade, 11000, Serbia

Location

Investigational Site Number 6880003

Belgrade, 11050, Serbia

Location

Investigational Site Number 6880005

Belgrade, 11050, Serbia

Location

Investigational Site Number 6880004

Kragujevac, 34000, Serbia

Location

Investigational Site Number 6880006

Novi Sad, 21000, Serbia

Location

Investigational Site Number 7030007

Bratislava, 85101, Slovakia

Location

Investigational Site Number 7030001

Košice, 040 01, Slovakia

Location

Investigational Site Number 7030004

Košice, 040 01, Slovakia

Location

Investigational Site Number 7030003

Kráľovský Chlmec, 077 01, Slovakia

Location

Investigational Site Number 7030009

Moldava nad Bodvou, 04525, Slovakia

Location

Investigational Site Number 7030010

Pezinok, 90201, Slovakia

Location

Investigational Site Number 7030006

Považská Bystrica, 01701, Slovakia

Location

Investigational Site Number 7030005

Prešov, 080 01, Slovakia

Location

Investigational Site Number 7030008

Rožňava, 04801, Slovakia

Location

Investigational Site Number 7030011

Štúrovo, 943 01, Slovakia

Location

Investigational Site Number 7030002

Trebišov, 075 01, Slovakia

Location

Investigational Site Number 7030012

Trenčín, 91101, Slovakia

Location

Investigational Site Number 7100007

Bloemfontein, 9301, South Africa

Location

Investigational Site Number 7100005

Cape Town, 7130, South Africa

Location

Investigational Site Number 7100006

Cape Town, South Africa

Location

Investigational Site Number 7100003

Johannesburg, 1752, South Africa

Location

Investigational Site Number 7100001

Johannesburg, 2198, South Africa

Location

Investigational Site Number 7100002

Parow, 7500, South Africa

Location

Investigational Site Number 7100004

Rivonia, 2128, South Africa

Location

Investigational Site Number 7100008

Umhlanga Rocks Suburb, South Africa

Location

Investigational Site Number 4100006

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Investigational Site Number 4100007

Busan, 49241, South Korea

Location

Investigational Site Number 4100005

Seoul, 02841, South Korea

Location

Investigational Site Number 4100002

Seoul, 03080, South Korea

Location

Investigational Site Number 4100009

Seoul, 03181, South Korea

Location

Investigational Site Number 4100001

Seoul, 03722, South Korea

Location

Investigational Site Number 4100011

Seoul, 06351, South Korea

Location

Investigational Site Number 4100003

Seoul, 06591, South Korea

Location

Investigational Site Number 4100010

Seoul, 08308, South Korea

Location

Investigational Site Number 4100008

Wŏnju, 26426, South Korea

Location

Investigational Site Number 7240008

Alcorcón, 28922, Spain

Location

Investigational Site Number 7240002

Barcelona, 08035, Spain

Location

Investigational Site Number 7240009

Barcelona, 08041, Spain

Location

Investigational Site Number 7240007

Granada, 18014, Spain

Location

Investigational Site Number 7240010

Madrid, 28023, Spain

Location

Investigational Site Number 7240001

Madrid, 28040, Spain

Location

Investigational Site Number 7240006

Majadahonda, 28222, Spain

Location

Investigational Site Number 7240011

Málaga, 29010, Spain

Location

Investigational Site Number 7240005

Olot, 17800, Spain

Location

Investigational Site Number 7240003

San Sebastián de los Reyes, 28702, Spain

Location

Investigational Site Number 7240013

Seville, 41014, Spain

Location

Investigational Site Number 7240004

Valencia, 46010, Spain

Location

Investigational Site Number 7240014

Valencia, 46026, Spain

Location

Investigational Site Number 7520006

Gothenburg, 41345, Sweden

Location

Investigational Site Number 7520003

Helsingborg, 252 20, Sweden

Location

Investigational Site Number 7520004

Kristianstad, 291 85, Sweden

Location

Investigational Site Number 7520002

Malmo, 211 52, Sweden

Location

Investigational Site Number 7520005

Skövde, 541 40, Sweden

Location

Investigational Site Number 7520001

Stockholm, 171 76, Sweden

Location

Investigational Site Number 7920005

Adana, 01250, Turkey (Türkiye)

Location

Investigational Site Number 7920010

Ankara, 06490, Turkey (Türkiye)

Location

Investigational Site Number 7920012

Antalya, 07070, Turkey (Türkiye)

Location

Investigational Site Number 7920015

Aydin, 09100, Turkey (Türkiye)

Location

Investigational Site Number 7920002

Bursa, 16059, Turkey (Türkiye)

Location

Investigational Site Number 7920013

Eskişehir, 26040, Turkey (Türkiye)

Location

Investigational Site Number 7920001

Istanbul, 34393, Turkey (Türkiye)

Location

Investigational Site Number 7920006

Istanbul, 34843, Turkey (Türkiye)

Location

Investigational Site Number 7920011

İzmit, 41380, Turkey (Türkiye)

Location

Investigational Site Number 7920014

Kütahya, 43040, Turkey (Türkiye)

Location

Investigational Site Number 7920007

Samsun, 55139, Turkey (Türkiye)

Location

Investigational Site Number 7920009

Sivas, 58140, Turkey (Türkiye)

Location

Investigational Site Number 8040006

Dnipro, 49005, Ukraine

Location

Investigational Site Number 8040009

Ivano-Frankivsk, 76008, Ukraine

Location

Investigational Site Number 8040001

Ivano-Frankivsk, 76018, Ukraine

Location

Investigational Site Number 8040003

Kharkiv, 61124, Ukraine

Location

Investigational Site Number 8040002

Kharkiv, 61166, Ukraine

Location

Investigational Site Number 8040007

Kiev, 02091, Ukraine

Location

Investigational Site Number 8040008

Kyiv, 01004, Ukraine

Location

Investigational Site Number 8040004

Ternopil, 46000, Ukraine

Location

Investigational Site Number 8040005

Vinnytsia, 21001, Ukraine

Location

Related Publications (5)

• 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.

  PMID: 34215025 RESULT

• 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.

  PMID: 39963952 DERIVED

• 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.

  PMID: 36802715 DERIVED

• 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.

  PMID: 34775781 DERIVED

• 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.

  PMID: 33026143 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

efpeglenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was terminated early by the Sponsor but not due to any safety concerns.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: April 27, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (18); SE (6); KR (10); FI (4); TU (12); ME (14); PL (15); ZA (8); RU (18); SL (12); ES (13); LI (4); US (79); HU (11); CL (13); DE (8); BU (15); PE (7); RO (10); IN (9); NO (3); LA (4); UA (9); CA (31); IT (6); DK (5)