Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:6/1/2018
Start Date:March 16, 2016
End Date:May 15, 2017

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A Repeat-dose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product

This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose,
study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic
response of albiglutide liquid drug product relative to the commercial lyophilized drug
product. The study will specifically evaluate the potential for immunogenicity (example
[e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).

Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long
half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent
are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring
reconstitution prior to use. A liquid formulation of albiglutide will enable the
commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an
auto-injector.

The primary hypothesis of this study is to test that liquid drug product will provide
glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug
product for a period of 26 weeks of treatment in subjects with T2DM.

This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and
for those subjects not entering the extension study a follow-up period (8 weeks).
Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active
liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI);
or, Albiglutide lyophilized DCC PI plus Placebo LAI.


Inclusion Criteria:

- 18 to 80 years of age inclusive

- Historical diagnosis of type 2 diabetes mellitus (T2DM) (at least 3 months),
experiencing inadequate glycemic control on current regimen of diet and exercise or on
a stable maximal tolerated dose of metformin, maintained for approximately 8 weeks
prior to screening.

- HbA1c >=7.0 percent (%) and <=10%.

- Hemoglobin >=11 grams per deciliter (g/dL) (>=110 grams per liter [g/L]) for males and
>=10 g/dL (>=100 g/L) for females.

- Body mass index <=40 kilograms per squared meter (kg/m^2)

- Male or female

- Able and willing to provide informed consent.

Exclusion Criteria:

- Type 1 diabetes mellitus

- History of cancer that has not been in full remission for at least 3 years before
screening. (A history of squamous cell or basal cell carcinoma of the skin or treated
cervical intra-epithelial neoplasia I or II is allowed).

- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia type 2.

- History of acute or chronic pancreatitis.

- History of thyroid dysfunction or an abnormal (i.e., outside the normal reference
range) thyroid function test assessed by thyroid stimulating hormone at screening.

- Severe gastroparesis, i.e., requiring regular therapy within 6 months before
screening.

- History of significant gastrointestinal (GI) surgery that in the opinion of the
investigator is likely to significantly affect upper GI or pancreatic function

- History of severe hypoglycemia unawareness

- Diabetic complications or any other clinically significant abnormality .

- Clinically significant Cardiovascular (CV) and/or cerebrovascular disease within 3
months before screening

- QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 470
milliseconds (msec).

- ALT >2.5x upper limit of the normal range (ULN) or bilirubin >1.5xULN (isolated
bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%).

- Current active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones or otherwise stable chronic liver disease per investigator
assessment).

- Estimated glomerular filtration rate (eGFR) <=30 milliliter (mL)/minute (min)/1.73
squared meter (m^2) (calculated using the Modification of Diet in Renal Disease [MDRD]
formula) at screening.

- Fasting triglyceride level >750 milligrams per deciliter (mg/dL) at screening.

- Hemoglobinopathy that may affect proper interpretation of HbA1c.

- Medical or psychiatric disorders that would preclude effective participation in study.

- Use of oral or systemically injected glucocorticoids within the 3 months before
randomization or high likelihood of a requirement for prolonged treatment (>1 week) in
the 6 months following randomization.

- Use of dipeptidyl peptidase-IV inhibitors within the 3 months before randomization.

- History of alcohol or substance abuse within one year before screening.

- Known allergy to albiglutide or any product components (including yeast and human
albumin), any other glucagon-like peptide-1 (GLP-1) analogue, or other study
medication's excipients OR other contraindications (per the prescribing information)
for the use of potential study medications.

- A positive pre-study drug/alcohol screen.

- A positive test for human immunodeficiency virus (HIV) antibody.

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
We found this trial at
72
sites
Hialeah, Florida 33013
2724
mi
from 98109
Hialeah, FL
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Albuquerque, New Mexico 87109
1183
mi
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Albuquerque, NM
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Altoona, Pennsylvania 16602
2204
mi
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Altoona, PA
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Anaheim, California 92807
981
mi
from 98109
Anaheim, CA
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Anderson, South Carolina 29621
2227
mi
from 98109
Anderson, SC
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Arlington, Texas 76014
1673
mi
from 98109
Arlington, TX
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Birmingham, Alabama 35249
2072
mi
from 98109
Birmingham, AL
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Bradenton, Florida 34208
2543
mi
from 98109
Bradenton, FL
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Brooksville, Florida 34613
2501
mi
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Brooksville, FL
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Canyon Country, California 91351
934
mi
from 98109
Canyon Country, CA
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Chandler, Arizona 85224
1128
mi
from 98109
Chandler, AZ
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Chesterfield, Missouri 63017
1704
mi
from 98109
Chesterfield, MO
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Chicago, Illinois 60611
1733
mi
from 98109
Chicago, IL
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Chula Vista, California 91911
1074
mi
from 98109
Chula Vista, CA
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Clearwater, Florida 33759
2515
mi
from 98109
Clearwater, FL
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Columbia, South Carolina 29203
2316
mi
from 98109
Columbia, SC
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Columbus, Ohio 43219
2009
mi
from 98109
Columbus, OH
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Conyers, Georgia 30094
2199
mi
from 98109
Conyers, GA
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Dallas, Texas 75230
1675
mi
from 98109
Dallas, TX
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Elgin, Illinois 60123
1698
mi
from 98109
Elgin, IL
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Evansville, Indiana 47714
1868
mi
from 98109
Evansville, IN
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Federal Way, Washington 98003
21
mi
from 98109
Federal Way, WA
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Fleming Island, Florida 32003
2460
mi
from 98109
Fleming Island, FL
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Fort Worth, Texas 76104
1662
mi
from 98109
Fort Worth, TX
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Fresno, California 93720
755
mi
from 98109
Fresno, CA
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Glendale, Arizona 85304
1104
mi
from 98109
Glendale, AZ
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Greensboro, North Carolina 27403
2295
mi
from 98109
Greensboro, NC
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Hallandale Beach, Florida 33009
2723
mi
from 98109
Hallandale Beach, FL
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
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Kalamazoo, Michigan 49007
1816
mi
from 98109
Kalamazoo, MI
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Katy, Texas 77450
1876
mi
from 98109
Katy, TX
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Lake Charles, Louisiana 70601
1954
mi
from 98109
Lake Charles, LA
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Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
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Lexington, Kentucky 40504
2003
mi
from 98109
Lexington, KY
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Littleton, Colorado 80120
1024
mi
from 98109
Littleton, CO
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Lomita, California 90717
978
mi
from 98109
Lomita, CA
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Los Angeles, California 90025
960
mi
from 98109
Los Angeles, CA
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Maumee, Ohio 43537
1927
mi
from 98109
Maumee, OH
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Meridian, Idaho 83642
399
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from 98109
Meridian, ID
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Mooresville, North Carolina 28117
2268
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Mooresville, NC
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Murray, Utah 84107
706
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Murray, UT
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Muscle Shoals, Alabama 35662
1988
mi
from 98109
Muscle Shoals, AL
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New Hyde Park, New York 11040
2416
mi
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New Hyde Park, NY
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New Orleans, Louisiana 70112
2099
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New Orleans, LA
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New Port Richey, Florida 34655
2505
mi
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New Port Richey, FL
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Norwood, Ohio 45212
1967
mi
from 98109
Norwood, OH
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Oceanside, California 92056
1031
mi
from 98109
Oceanside, CA
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Omaha, Nebraska 68131
1365
mi
from 98109
Omaha, NE
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Orlando, Florida 32806
2549
mi
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Orlando, FL
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Perrysburg, Ohio 43551
1929
mi
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Perrysburg, OH
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Pharr, Texas 78577
1977
mi
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Pharr, TX
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Phoenix, Arizona 85012
1112
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Phoenix, AZ
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Sacramento, California 95815
626
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Sacramento, CA
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Saint Louis, Missouri 63110
1718
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Saint Louis, MO
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Saint Petersburg, Florida 33713
2525
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Saint Petersburg, FL
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San Antonio, Texas 78258
1776
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San Antonio, TX
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San Diego, California 92111
1058
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San Diego, CA
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Schertz, Texas 78215
1788
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Schertz, TX
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Searcy, Arkansas 72143
1784
mi
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Searcy, AR
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Shelby, North Carolina 28152
Phone: 877-379-3718
2246
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Shelby, NC
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Snellville, Georgia 30078
2191
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Snellville, GA
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Spokane, Washington 99208
226
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Spokane, WA
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Spring, Texas 77379
1870
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Spring, TX
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Spring Valley, California 91978
656
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Spring Valley, CA
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Tacoma, Washington 98405
27
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Tacoma, WA
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Topeka, Kansas 66604
1453
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Topeka, KS
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Troy, Michigan 48085
1922
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Troy, MI
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Tustin, California 92780
988
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Tustin, CA
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Van Nuys, California 91405
949
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Van Nuys, CA
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Walnut Creek, California 94596
673
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Walnut Creek, CA
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