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
Kalamazoo, Michigan 49007
209
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from 43215
Kalamazoo, MI
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Albuquerque, New Mexico 87109
1327
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Albuquerque, NM
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Altoona, Pennsylvania 16602
247
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Altoona, PA
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Anaheim, California 92807
1953
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Anaheim, CA
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Anderson, South Carolina 29621
377
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Anderson, SC
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Arlington, Texas 76014
928
mi
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Arlington, TX
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Birmingham, Alabama 35249
493
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Birmingham, AL
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Bradenton, Florida 34208
861
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Bradenton, FL
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Brooksville, Florida 34613
789
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Brooksville, FL
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Canyon Country, California 91351
1974
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Canyon Country, CA
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Chandler, Arizona 85224
1655
mi
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Chandler, AZ
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Chesterfield, Missouri 63017
411
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Chesterfield, MO
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Chicago, Illinois 60611
274
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Chicago, IL
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Chula Vista, California 91911
1948
mi
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Chula Vista, CA
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Clearwater, Florida 33759
828
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Clearwater, FL
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Columbia, South Carolina 29203
418
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Columbia, SC
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Columbus, Ohio 43219
7
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Columbus, OH
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Conyers, Georgia 30094
438
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Conyers, GA
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Dallas, Texas 75230
905
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Dallas, TX
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Elgin, Illinois 60123
309
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Elgin, IL
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Evansville, Indiana 47714
278
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Evansville, IN
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Federal Way, Washington 98003
2006
mi
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Federal Way, WA
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Fleming Island, Florida 32003
685
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Fleming Island, FL
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Fort Worth, Texas 76104
937
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Fort Worth, TX
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Fresno, California 93720
1986
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Fresno, CA
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Glendale, Arizona 85304
1663
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Glendale, AZ
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Greensboro, North Carolina 27403
320
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Greensboro, NC
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Hallandale Beach, Florida 33009
980
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Hallandale Beach, FL
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Hialeah, Florida 33013
987
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Hialeah, FL
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Houston, Texas 77030
995
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Houston, TX
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Jacksonville, Florida 32207
672
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Jacksonville, FL
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Katy, Texas 77450
1007
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Katy, TX
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Lake Charles, Louisiana 70601
884
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Lake Charles, LA
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Las Vegas, Nevada 89102
1759
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Las Vegas, NV
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Lexington, Kentucky 40504
156
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Lexington, KY
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Littleton, Colorado 80120
1164
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Littleton, CO
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Lomita, California 90717
1982
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Lomita, CA
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Los Angeles, California 90025
1983
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Los Angeles, CA
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Maumee, Ohio 43537
115
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Maumee, OH
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Meridian, Idaho 83642
1725
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Meridian, ID
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Miami, Florida 33136
992
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Mooresville, North Carolina 28117
325
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Murray, Utah 84107
1514
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Muscle Shoals, Alabama 35662
441
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Muscle Shoals, AL
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New Hyde Park, New York 11040
494
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New Orleans, Louisiana 70112
797
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New Port Richey, Florida 34655
814
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Norwood, Ohio 45212
94
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Norwood, OH
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Oceanside, California 92056
1945
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Omaha, Nebraska 68131
683
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Orlando, Florida 32806
797
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Perrysburg, Ohio 43551
114
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Pharr, Texas 78577
1290
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Phoenix, Arizona 85012
1660
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Sacramento, California 95815
2040
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Saint Louis, Missouri 63110
397
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Saint Petersburg, Florida 33713
842
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San Antonio, Texas 78258
1126
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San Diego, California 92111
1948
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Schertz, Texas 78215
1122
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Searcy, Arkansas 72143
577
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Shelby, North Carolina 28152
Phone: 877-379-3718
332
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Snellville, Georgia 30078
425
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Spokane, Washington 99208
1781
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Spring, Texas 77379
984
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Spring Valley, California 91978
2014
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Tacoma, Washington 98405
2013
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Topeka, Kansas 66604
679
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Troy, Michigan 48085
182
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Tustin, California 92780
1957
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Van Nuys, California 91405
1979
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Walnut Creek, California 94596
2084
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