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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 : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Efpeglenatide (SAR439977) Drug: Placebo Phase 3

Detailed Description:
The estimated study duration per participant is up to approximately 36 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4076 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Efpeglenatide Dose 1
Efpeglenatide dose 1 once weekly
Drug: Efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Experimental: Efpeglenatide Dose 2
Efpeglenatide dose 2 once weekly
Drug: Efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Placebo Comparator: Placebo
Placebo once weekly
Drug: Placebo

Pharmaceutical form: solution for injection

Route of administration: subcutaneous





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Adverse Events (AEs) [ Time Frame: Baseline to approximately 36 months ]
    Number of patients with AEs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496298


  Show 355 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03496298     History of Changes
Other Study ID Numbers: EFC14828
2017-002954-35 ( EudraCT Number )
U1111-1186-2533 ( Other Identifier: UTN )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases