Effect of Efpeglenatide on Cardiovascular Outcomes



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:April 27, 2018
End Date:April 2021
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

Use our guide to learn which trials are right for you!

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

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.

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

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.
We found this trial at
80
sites
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
?
mi
from
Beaver, PA
Click here to add this to my saved trials
?
mi
from
Bend, OR
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Concord, CA
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hudson, FL
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Lorain, OH
Click here to add this to my saved trials
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Manitowoc, WI
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
?
mi
from
Morganton, NC
Click here to add this to my saved trials
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Albany, IN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Oxon Hill, MD
Click here to add this to my saved trials
?
mi
from
Paris, KY
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Pomona, CA
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Richmond, TX
Click here to add this to my saved trials
?
mi
from
Roswell, GA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Sheffield, AL
Click here to add this to my saved trials
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
?
mi
from
Surprise, AZ
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
?
mi
from
Warren, NJ
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Waterbury, CT
Click here to add this to my saved trials