Last updated: 07/17/2024 17:05:18
Safety and Efficacy study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Repeat-dose Study in Subjects with Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycated hemoglobin (HbA1c) at Week 26
Timeframe: Baseline and Week 26
Secondary outcomes:
Number of participants with on-therapy adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to Week 26
Number of participants with clinical chemistry parameters of potential clinical concern (PCC)
Timeframe: Up to Week 26
Number of participants with hematology parameters of PCC
Timeframe: Up to Week 26
Number of participants with vital signs of PCC
Timeframe: Up to Week 34
Number of participants with electrocardiogram (ECG) parameters of PCC
Timeframe: Up to Week 26
Number of participants with positive result for anti-albiglutide Antibody
Timeframe: Up to Week 34
Number of participants with injection site reactions (ISR)
Timeframe: Up to Week 34
Change from Baseline in fasting plasma glucose (FPG) at Week 26
Timeframe: Baseline and Week 26
Change from Baseline in HbA1c over time
Timeframe: Baseline and up to Week 26
Change from Baseline in FPG over time
Timeframe: Baseline and up to Week 26
Trough plasma concentration of albiglutide over time
Timeframe: Pre-dose at Week 12 and Week 26
Interventions:
Drug: Lyophilized albiglutide DCC pen injector
Drug: Lyophilized albiglutide DCC pen injector matching placebo
Drug: Albiglutide liquid auto-injector
Drug: Albiglutide liquid auto-injector matching placebo
Enrollment:
308
Observational study model:
Not applicable
Primary completion date:
2017-03-04
Time perspective:
Not applicable
Clinical publications:
Bonnie C. Shaddinger, Joseph Soffer, Georgios Vlasakakis, Mayadah Shabbout, Cynthia Weston, Antonio Nino. Efficacy and Safety of an Albiglutide Liquid Formulation Compared With the Lyophilized Formulation: A 26-Week Randomized, Double-Blind, Repeat-Dose Study in Patients With Type 2 Diabetes Mellitus. Diabetes Res Clin Pract. 2019;31627-9
DOI: 10.1016/j.diabres.2019.04.018
PMID: 31004676
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
March 2016 to May 2017
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion criteria
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).
Trial location(s)
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
Status
Study Complete
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76012
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35216
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Bradenton, Florida, United States, 34208
Status
Study Complete
Location
GSK Investigational Site
Brooksville, Florida, United States, 34601
Status
Study Complete
Location
GSK Investigational Site
Canyon Country, California, United States, 91351
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Chula Vista, California, United States, 91911
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765-2616
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Study Complete
Location
GSK Investigational Site
Conyers, Georgia, United States, 30094
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Federal Way, Washington, United States, 98003
Status
Study Complete
Location
GSK Investigational Site
Fleming Island, Florida, United States, 32003
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27405
Status
Study Complete
Location
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33016
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Lake Charles, Louisiana, United States, 70601
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89123
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80128
Status
Study Complete
Location
GSK Investigational Site
Lomita, California, United States, 90717
Status
Study Complete
Location
GSK Investigational Site
Maumee, Ohio, United States, 43537-9402
Status
Study Complete
Location
GSK Investigational Site
New Hyde Park, New York, United States, 11042
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70119
Status
Study Complete
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34652
Status
Study Complete
Location
GSK Investigational Site
Oceanside, California, United States, 92056
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32825
Status
Study Complete
Location
GSK Investigational Site
Perrysburg, Ohio, United States, 43551
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95821
Status
Study Complete
Location
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78231
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28150
Status
Study Complete
Location
GSK Investigational Site
Snellville, Georgia, United States, 30078
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33709
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
Van Nuys, California, United States, 91405
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2017-03-04
Actual study completion date
2017-15-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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