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
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Miami, Florida 33136
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Albuquerque, New Mexico 87109
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Altoona, Pennsylvania 16602
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Anaheim, California 92807
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Anderson, South Carolina 29621
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Arlington, Texas 76014
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Birmingham, Alabama 35249
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Bradenton, Florida 34208
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Brooksville, Florida 34613
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Canyon Country, California 91351
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Chandler, Arizona 85224
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Chesterfield, Missouri 63017
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Chicago, Illinois 60611
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Chula Vista, California 91911
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Clearwater, Florida 33759
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Columbia, South Carolina 29203
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Columbus, Ohio 43219
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Conyers, Georgia 30094
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Dallas, Texas 75230
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Elgin, Illinois 60123
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Evansville, Indiana 47714
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Federal Way, Washington 98003
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Fleming Island, Florida 32003
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Fort Worth, Texas 76104
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Fresno, California 93720
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Glendale, Arizona 85304
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Greensboro, North Carolina 27403
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Hallandale Beach, Florida 33009
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Hialeah, Florida 33013
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Houston, Texas 77030
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Kalamazoo, Michigan 49007
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Katy, Texas 77450
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Lake Charles, Louisiana 70601
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Lexington, Kentucky 40504
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Littleton, Colorado 80120
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Lomita, California 90717
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Maumee, Ohio 43537
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Meridian, Idaho 83642
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Mooresville, North Carolina 28117
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Murray, Utah 84107
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Muscle Shoals, Alabama 35662
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New Port Richey, Florida 34655
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Norwood, Ohio 45212
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Oceanside, California 92056
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Perrysburg, Ohio 43551
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Pharr, Texas 78577
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Sacramento, California 95815
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Saint Louis, Missouri 63110
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Searcy, Arkansas 72143
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Shelby, North Carolina 28152
Phone: 877-379-3718
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Troy, Michigan 48085
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Tustin, California 92780
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Van Nuys, California 91405
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