Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:7/5/2018
Start Date:January 2013
End Date:August 2014

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

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once
weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with
type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of
exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.


Inclusion Criteria:

- At least 18 years old

- Diagnosed with type 2 diabetes mellitus

- HbA1c 7.1 to 11%, inclusive, at screening

- Fasting plasma glucose <280 mg/dL (15.5 mmol/L)

- Body mass index (BMI) <=45 kg/m2, inclusive, at screening

- Treated with diet and exercise or a stable regimen of metformin, sulfonylurea,
pioglitazone or any 2 of these agents

Exclusion Criteria:

- History of pancreatitis or triglycerides >=500 mg/dL

- Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of
either

- Active cardiovascular disease

- Presence of congestive heart failure

- Liver disease

- History of severe gastrointestinal diseases

- Repeated severe hypoglycemia within the last 6 months

- Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog

- Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
We found this trial at
55
sites
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Butte, MT
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
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
Columbia, MD
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Edina, MN
Click here to add this to my saved trials
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
?
mi
from
Endwell, NY
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Harleysville, PA
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Lomita, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Manassas, VA
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
?
mi
from
Murray, UT
Click here to add this to my saved trials
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
New Bedford, Massachusetts 02740
?
mi
from
New Bedford, MA
Click here to add this to my saved trials
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Olympia, WA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Oviedo, FL
Click here to add this to my saved trials
?
mi
from
Paducah, KY
Click here to add this to my saved trials
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Ponte Vedra, FL
Click here to add this to my saved trials
?
mi
from
Port Gibson, MS
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Richmond, VA
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
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials