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Trial record 1 of 1 for:    EFC14828
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Effect of Efpeglenatide on Cardiovascular Outcomes (AMPLITUDE-O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496298
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE April 27, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Time to first Major Adverse Cardiovascular Event (MACE) [ Time Frame: Baseline to approximately 36 months ]
Time to the first occurrence of any of the following clinical events: cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Time to first expanded cardiovascular outcome event [ Time Frame: Baseline to approximately 36 months ]
    Time to the first occurrence of any of the following clinical events, positively adjudicated by the clinical endpoint committee (CEC): cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, hospitalization for unstable angina.
  • Time to first composite renal event [ Time Frame: Baseline to approximately 36 months ]
    Time to the first occurrence of any of the following clinical events: new onset or progression to macro albuminuria (>300 mg/g) accompanied by a UACR value increase of ≥30% from baseline, sustained ≥40% decrease in eGFR from baseline (for ≥30 days), chronic dialysis (for ≥90 days), renal transplant, sustained eGFR <15 mL/min/1.73 m2 (for ≥30 days).
  • Adverse Events (AEs) [ Time Frame: Baseline to approximately 36 months ]
    Number of patients with AEs
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • Time to first expanded cardiovascular outcome event [ Time Frame: Baseline to approximately 36 months ]
    Time to the first occurrence of any of the following clinical events, positively adjudicated by the clinical endpoint committee (CEC): cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, hospitalization for unstable angina.
  • Time to first composite renal event [ Time Frame: Baseline to approximately 36 months ]
    Time to the first occurrence of any of the following clinical events: new onset or progression to macro albuminuria (>300 mg/g) accompanied by a urinary albumin-creatinine ratio (UACR) value increase of ≥30% from baseline, sustained ≥40% decrease in eGFR from baseline (for ≥30 days), chronic dialysis (for ≥90 days), renal transplant, sustained eGFR <15 mL/min/1.73 m2 (for ≥30 days).
  • Adverse Events (AEs) [ Time Frame: Baseline to approximately 36 months ]
    Number of patients with AEs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Efpeglenatide on Cardiovascular Outcomes
Official Title  ICMJE 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
Brief Summary

Primary Objective:

-To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk.

Secondary Objectives:

  • To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients 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 doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.
Detailed Description The estimated study duration per participant is up to approximately 36 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Efpeglenatide (SAR439977)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Drug: Placebo

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

Study Arms  ICMJE
  • Experimental: Efpeglenatide Dose 1
    Efpeglenatide dose 1 once weekly
    Intervention: Drug: Efpeglenatide (SAR439977)
  • Experimental: Efpeglenatide Dose 2
    Efpeglenatide dose 2 once weekly
    Intervention: Drug: Efpeglenatide (SAR439977)
  • Placebo Comparator: Placebo
    Placebo once weekly
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 6, 2019)
4076
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
4000
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) > 7%.
  • Age 18 years or older with established cardiovascular disease or age 50 years (male), 55 years (female) or older with eGFR ≥25 and <60 mL/min and at least one cardiovascular risk factor.
  • Female patients must agree 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 (MTC).
  • Hypertension (with a systolic blood pressure >180 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 (GLP-1) receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
  • Use of any DPP4 inhibitor within 3 months prior to screening.
  • Antihyperglycemic treatment has not been stable within 3 months prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Canada,   Chile,   Denmark,   Estonia,   Finland,   Germany,   Hungary,   India,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03496298
Other Study ID Numbers  ICMJE EFC14828
2017-002954-35 ( EudraCT Number )
U1111-1186-2533 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP