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
Greensboro, North Carolina 27403
999
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Greensboro, NC
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Albuquerque, New Mexico 87109
517
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Albuquerque, NM
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Altoona, Pennsylvania 16602
1056
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Anaheim, California 92807
1148
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Anderson, South Carolina 29621
874
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Arlington, Texas 76014
351
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Arlington, TX
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Birmingham, Alabama 35249
676
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Bradenton, Florida 34208
1132
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Brooksville, Florida 34613
1093
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Canyon Country, California 91351
1173
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Chandler, Arizona 85224
846
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Chesterfield, Missouri 63017
400
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Chicago, Illinois 60611
611
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Chicago, IL
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Chula Vista, California 91911
1139
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Clearwater, Florida 33759
1105
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Clearwater, FL
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Columbia, South Carolina 29203
969
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Columbia, SC
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Columbus, Ohio 43219
815
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Conyers, Georgia 30094
823
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Dallas, Texas 75230
340
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Elgin, Illinois 60123
585
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Evansville, Indiana 47714
561
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Evansville, IN
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Federal Way, Washington 98003
1403
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Federal Way, WA
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Fleming Island, Florida 32003
1061
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Fort Worth, Texas 76104
348
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Fresno, California 93720
1205
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Glendale, Arizona 85304
854
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Hallandale Beach, Florida 33009
1313
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Hialeah, Florida 33013
1313
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Houston, Texas 77030
572
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Jacksonville, Florida 32207
1058
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Kalamazoo, Michigan 49007
718
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Katy, Texas 77450
565
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Lake Charles, Louisiana 70601
582
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Las Vegas, Nevada 89102
963
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Lexington, Kentucky 40504
723
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Littleton, Colorado 80120
408
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Lomita, California 90717
1178
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Los Angeles, California 90025
1179
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Maumee, Ohio 43537
797
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Meridian, Idaho 83642
1050
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Miami, Florida 33136
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Mooresville, North Carolina 28117
953
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Murray, Utah 84107
778
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Muscle Shoals, Alabama 35662
602
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70112
697
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New Port Richey, Florida 34655
1096
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Norwood, Ohio 45212
728
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Oceanside, California 92056
1138
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Omaha, Nebraska 68131
262
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Orlando, Florida 32806
1144
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Perrysburg, Ohio 43551
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Pharr, Texas 78577
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Phoenix, Arizona 85012
850
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Sacramento, California 95815
1280
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Saint Louis, Missouri 63110
415
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Saint Petersburg, Florida 33713
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San Antonio, Texas 78258
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San Diego, California 92111
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Schertz, Texas 78215
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Searcy, Arkansas 72143
379
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Shelby, North Carolina 28152
Phone: 877-379-3718
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Snellville, Georgia 30078
817
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Spokane, Washington 99208
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Spring, Texas 77379
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Spring Valley, California 91978
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Tacoma, Washington 98405
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Topeka, Kansas 66604
144
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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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Walnut Creek, California 94596
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