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TerminatedNCT03496298AMPLITUDE-OUpdated Oct 15, 2021Results posted

Effect of Efpeglenatide on Cardiovascular Outcomes

A Phase 3 interventional study of Efpeglenatide (SAR439977) and Placebo in Type 2 Diabetes Mellitus, sponsored by Sanofi. Terminated at 353 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor decision to cancel TRIAL, not related to safety concern
Phase
Phase 3
Study type
Interventional
Enrollment
4,076
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,076 participants (actual)

Study arms

  • Placebo comparator
    Placebo

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

    Drug: Placebo

  • Experimental
    Efpeglenatide 4 mg

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

    Drug: Efpeglenatide (SAR439977)

  • Experimental
    Efpeglenatide 6 mg

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

    Drug: Efpeglenatide (SAR439977)

Interventions

  • DrugEfpeglenatide (SAR439977)

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

  • DrugPlacebo

    Pharmaceutical form: Solution for injection Route of administration: SC

05

What researchers measure

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.

    Time frame: 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

  1. 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.

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

  2. 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.

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

  3. 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.

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

06

Results

Posted Oct 15, 2021
Limitations and caveats
The study was terminated early by the Sponsor but not due to any safety concerns.

Participant flow

The study was conducted at 344 active sites in 28 countries. Overall, 5732 participants were screened between 27 April 2018 and 25 April 2019; of whom 4076 participants were randomized by interactive response technology (1:1:1 ratio) to receive placebo, efpeglenatide 4 milligrams (mg) or efpeglenatide 6 mg. Screen failures were mainly due to inclusion criteria not met.

Participant flow — Overall Study
MilestonePlaceboEfpeglenatide 4 mgEfpeglenatide 6 mg
Started135913591358
Randomized and treated135813581357
Safety population135513601358
Completed423623
Not completed131713231335
Withdrew: Adverse event496879
Withdrew: Study terminated by sponsor105010631071
Withdrew: Physician decision (other than adverse event)121710
Withdrew: Withdrawal by subject176154151
Withdrew: Other292023
Withdrew: Randomized and not treated111

Outcome measures

PrimaryTime 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.

Time frame:
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Reported as:
Number · events per 100 participant-years
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
events per 100 participant-yearsEfpeglenatide 4 mg+6 mgPlacebo
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 Analysis3.9 (3.4 to 4.5)5.3 (4.4 to 6.3)
Statistical analysis
  • Efpeglenatide 4 mg+6 mg vs Placebo · Log Rank · p = <.0001 (One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.) · Hazard ratio (hr): 0.732 · 95% CI 0.583 to 0.918
SecondaryTime 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.

Time frame:
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Reported as:
Number · events per 100 participant-years
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis
events per 100 participant-yearsEfpeglenatide 4 mg+6 mgPlacebo
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis3.9 (3.4 to 4.5)5.3 (4.4 to 6.3)
Statistical analysis
  • Efpeglenatide 4 mg+6 mg vs Placebo · Log Rank · p = 0.0069 (Two-sided p-values based on log rank test of hazard ratio.) · Hazard ratio (hr): 0.732 · 95% CI 0.583 to 0.918
SecondaryTime 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.

Time frame:
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Reported as:
Number · events per 100 participant-years
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
events per 100 participant-yearsEfpeglenatide 4 mg+6 mgPlacebo
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 Event5.46.8
Statistical analysis
  • Efpeglenatide 4 mg+6 mg vs Placebo · Log Rank · p = 0.02 (Two-sided p-values based on log rank test of hazard ratio.) · Hazard ratio (hr): 0.79 · 95% CI 0.65 to 0.96
SecondaryTime 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.

Time frame:
From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)
Reported as:
Number · events per 100 participant-years
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint
events per 100 participant-yearsEfpeglenatide 4 mg+6 mgPlacebo
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint7.7 (6.9 to 8.6)11.6 (10.2 to 13.1)
Statistical analysis
  • Efpeglenatide 4 mg+6 mg vs Placebo · Log Rank · p = <.0001 (Two-sided p-values based on log rank test of hazard ratio.) · Hazard ratio (hr): 0.675 · 95% CI 0.574 to 0.794

Adverse events

Collected over From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo49/1,355 (3.6%)298/1,355 (22%)151/1,355 (11.1%)
Efpeglenatide 4 mg40/1,360 (2.9%)312/1,360 (22.9%)348/1,360 (25.6%)
Efpeglenatide 6 mg25/1,358 (1.8%)275/1,358 (20.3%)342/1,358 (25.2%)
Most frequent serious events
Showing 10 of 484
Most frequent serious events
EventPlaceboEfpeglenatide 4 mgEfpeglenatide 6 mg
Angina UnstableCardiac disorders23/135520/136010/1358
Angina PectorisCardiac disorders10/13558/136017/1358
PneumoniaInfections and infestations15/135514/13609/1358
Atrial FibrillationCardiac disorders12/135515/136012/1358
Coronary Artery DiseaseCardiac disorders10/135514/13605/1358
Cardiac FailureCardiac disorders12/13554/13601/1358
Acute Kidney InjuryRenal and urinary disorders9/135510/136010/1358
Peripheral Arterial Occlusive DiseaseVascular disorders8/13557/136010/1358
Myocardial InfarctionCardiac disorders9/13554/13606/1358
SepsisInfections and infestations9/13554/13604/1358
Most frequent other events
Most frequent other events
EventPlaceboEfpeglenatide 4 mgEfpeglenatide 6 mg
NauseaGastrointestinal disorders51/1355196/1360167/1358
DiarrhoeaGastrointestinal disorders64/1355116/1360117/1358
VomitingGastrointestinal disorders18/135585/136075/1358
Decreased AppetiteMetabolism and nutrition disorders15/135568/136077/1358
HypoglycaemiaMetabolism and nutrition disorders37/135573/136053/1358

Baseline characteristics

Analysis was performed on Intent-to-treat (ITT) population that included all randomized participants irrespective of compliance with the study protocol and procedures and were analyzed in the treatment group to which they were randomized.

Age, Continuous
Age, Continuous(years)PlaceboEfpeglenatide 4 mgEfpeglenatide 6 mgTotal
Mean64.4 ± 8.364.6 ± 8.264.7 ± 8.264.5 ± 8.2
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboEfpeglenatide 4 mgEfpeglenatide 6 mgTotal
Female4194424831344
Male9409178752732
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboEfpeglenatide 4 mgEfpeglenatide 6 mgTotal
American Indian or Alaska Native118827
Asian988782267
Native Hawaiian or Other Pacific Islander0123
Black or African American503855143
White1162119211803534
More than one race49518
Unknown or Not Reported34242684
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram meter per square (kg/m^2))PlaceboEfpeglenatide 4 mgEfpeglenatide 6 mgTotal
Mean32.40 ± 6.0132.81 ± 6.2232.90 ± 6.2132.70 ± 6.15
07

Study locations

353 sites
  • Investigational Site Number 8400032
    Sheffield, Alabama 35660, United States
  • Investigational Site Number 8400014
    Gilbert, Arizona 85295, United States
  • Investigational Site Number 8400012
    Surprise, Arizona 85374, United States
  • Investigational Site Number 8400046
    Tucson, Arizona 85745, United States
  • Investigational Site Number 8400022
    Beverly Hills, California 90211, United States
  • Investigational Site Number 8400065
    Concord, California 94520, United States
  • Investigational Site Number 8400060
    Greenbrae, California 94904, United States
  • Investigational Site Number 8400084
    Long Beach, California 90807, United States
  • Investigational Site Number 8400002
    Los Gatos, California 95032, United States
  • Investigational Site Number 8400085
    Northridge, California 91325, United States
  • Investigational Site Number 8400082
    Pomona, California 91767, United States
  • Investigational Site Number 8400025
    Sacramento, California 95821, United States
  • Investigational Site Number 8400064
    Englewood, Colorado 80113, United States
  • Investigational Site Number 8400019
    Hamden, Connecticut 06517, United States
  • Investigational Site Number 8400023
    Waterbury, Connecticut 06708-3346, United States
  • Investigational Site Number 8400091
    Hialeah, Florida 33012, United States
  • Investigational Site Number 8400040
    Hollywood, Florida 33024, United States
  • Investigational Site Number 8400073
    Hudson, Florida 34667, United States
  • Investigational Site Number 8400011
    Jacksonville, Florida 32204, United States
  • Investigational Site Number 8400017
    Jacksonville, Florida 32204, United States
  • Investigational Site Number 8400042
    Jacksonville, Florida 32277, United States
  • Investigational Site Number 8400027
    Miami, Florida 33126, United States
  • Investigational Site Number 8400051
    Miami, Florida 33136, United States
  • Investigational Site Number 8400041
    New Port Richey, Florida 34652, United States
  • Investigational Site Number 8400059
    Ormond Beach, Florida 32174, United States
  • Investigational Site Number 8400006
    Macon, Georgia 31210-1359, United States
  • Investigational Site Number 8400008
    Roswell, Georgia 30076, United States
  • Investigational Site Number 8400081
    Idaho Falls, Idaho 83404, United States
  • Investigational Site Number 8400095
    Arlington Heights, Illinois 60005, United States
  • Investigational Site Number 8400070
    Chicago, Illinois 60607, United States
  • Investigational Site Number 8400036
    Crystal Lake, Illinois 60012, United States
  • Investigational Site Number 8400030
    New Albany, Indiana 46113, United States
  • Investigational Site Number 8400074
    Topeka, Kansas 66606, United States
  • Investigational Site Number 8400077
    Owensboro, Kentucky 42303, United States
  • Investigational Site Number 8400043
    Paris, Kentucky 40361, United States
  • Investigational Site Number 8400034
    Alexandria, Louisiana 71301, United States
  • Investigational Site Number 8400079
    Monroe, Louisiana 71203, United States
  • Investigational Site Number 8400013
    New Orleans, Louisiana 70112, United States
  • Investigational Site Number 8400047
    Oxon Hill, Maryland 20745, United States
  • Investigational Site Number 8400001
    Flint, Michigan 48504, United States
  • Investigational Site Number 8400061
    Flint, Michigan 48532-3447, United States
  • Investigational Site Number 8400010
    Troy, Michigan 48085, United States
  • Investigational Site Number 8400005
    Troy, Michigan 48098, United States
  • Investigational Site Number 8400024
    Saint Paul, Minnesota 55102, United States
  • Investigational Site Number 8400045
    Saint Louis, Missouri 63136, United States
  • Investigational Site Number 8400071
    Billings, Montana 59103, United States
  • Investigational Site Number 8400028
    Great Falls, Montana 59405-4507, United States
  • Investigational Site Number 8400086
    Kalispell, Montana 59901, United States
  • Investigational Site Number 8400037
    Las Vegas, Nevada 89128, United States
  • Investigational Site Number 8400087
    Raritan, New Jersey 08869, United States
  • Investigational Site Number 8400018
    Bronx, New York 00000, United States
  • Investigational Site Number 8400056
    Staten Island, New York 10301, United States
  • Investigational Site Number 8400076
    Greenville, North Carolina 27834-5704, United States
  • Investigational Site Number 8400007
    Morehead City, North Carolina 28557, United States
  • Investigational Site Number 8400093
    Morehead City, North Carolina 28557, United States
  • Investigational Site Number 8400094
    Morganton, North Carolina 28655, United States
  • Investigational Site Number 8400029
    Fargo, North Dakota 58104, United States
  • Investigational Site Number 8400031
    Columbus, Ohio 43203, United States
  • Investigational Site Number 8400078
    Lorain, Ohio 44053, United States
  • Investigational Site Number 8400072
    Bend, Oregon 97702, United States
  • Investigational Site Number 8400067
    Beaver, Pennsylvania 15009-1957, United States
  • Investigational Site Number 8400096
    Philadelphia, Pennsylvania 19107, United States
  • Investigational Site Number 8400021
    Pittsburgh, Pennsylvania 15212, United States
  • Investigational Site Number 8400015
    Greer, South Carolina 29651, United States
  • Investigational Site Number 8400063
    Murrells Inlet, South Carolina 29576, United States
  • Investigational Site Number 8400044
    Rapid City, South Dakota 57702, United States
  • Investigational Site Number 8400016
    Memphis, Tennessee 38163, United States
  • Investigational Site Number 8400009
    Nashville, Tennessee 37203, United States
  • Investigational Site Number 8400055
    Corpus Christi, Texas 78814, United States
  • Investigational Site Number 8400097
    Dallas, Texas 75230, United States
  • Investigational Site Number 8400088
    El Paso, Texas 79935, United States
  • Investigational Site Number 8400058
    Fort Worth, Texas 76132, United States
  • Investigational Site Number 8400069
    Houston, Texas 77004, United States
  • Investigational Site Number 8400089
    Houston, Texas 77030, United States
  • Investigational Site Number 8400092
    Richmond, Texas 77469, United States
  • Investigational Site Number 8400033
    Waco, Texas 76710, United States
  • Investigational Site Number 8400039
    Salt Lake City, Utah 84102, United States
  • Investigational Site Number 8400052
    Norfolk, Virginia 23510, United States
  • Investigational Site Number 8400049
    Manitowoc, Wisconsin 54220, United States
  • Investigational Site Number 0320009
    Buenos Aires, 1430, Argentina
  • Investigational Site Number 0320002
    Caba, 1120, Argentina
  • Investigational Site Number 0320013
    Caba, 1425DES, Argentina
  • Investigational Site Number 0320010
    Caba, 1425, Argentina
  • Investigational Site Number 0320005
    Caba, C1119ACN, Argentina
  • Investigational Site Number 0320008
    Capital Federal, C1056ABJ, Argentina
  • Investigational Site Number 0320001
    Capital Federal, C1179AAB, Argentina
  • Investigational Site Number 0320004
    Corrientes, W3400AMZ, Argentina
  • Investigational Site Number 0320012
    Corrientes, W3410AVV, Argentina
  • Investigational Site Number 0320011
    Godoy Cruz, M5501ARP, Argentina
  • Investigational Site Number 0320007
    Mar Del Plata, B7600FZN, Argentina
  • Investigational Site Number 0320006
    Merlo, B1722COV, Argentina
  • Investigational Site Number 0320015
    Rosario, 2000, Argentina
  • Investigational Site Number 0320017
    Rosario, S2002OJP, Argentina
  • Investigational Site Number 0320003
    Salta, 4400, Argentina
  • Investigational Site Number 0320018
    Salta, 4400, Argentina
  • Investigational Site Number 0320016
    San Isidro, B1642DCB, Argentina
  • Investigational Site Number 0320014
    Santa Rosa, Argentina
  • Investigational Site Number 1000011
    Blagoevgrad, 2700, Bulgaria
  • Investigational Site Number 1000014
    Dimitrovgrad, Bulgaria
  • Investigational Site Number 1000017
    Gabrovo, 5300, Bulgaria

Showing the first 100 of 353 sites across 28 countries.

08

References and documents

Publications

  • 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. PubMed 34215025 ↗
  • 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. Erratum In: Circulation. 2023 Jun 6;147(23):e720. doi: 10.1161/CIR.0000000000001157. PubMed 34775781 ↗
  • 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. PubMed 33026143 ↗

Study documents

  • Study protocol · Jul 30, 2018
  • Statistical analysis plan · Aug 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.

09

Registry details

Key details

Study ID
NCT03496298
Lead sponsor
Sanofi
Collaborators
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
Apr 27, 2018
Primary completion
Dec 10, 2020
Completion
Dec 10, 2020
Results posted
Oct 15, 2021
Last update
Oct 15, 2021

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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