Pharmacokinetics/Pharmacodynamics of Albiglutide
A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide
1 other identifier
interventional
283
1 country
30
Brief Summary
The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jul 2011
Typical duration for phase_2 diabetes-mellitus-type-2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
May 23, 2014
CompletedJanuary 9, 2017
November 1, 2016
1.3 years
May 19, 2011
April 24, 2014
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase
To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase
To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Secondary Outcomes (16)
Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)
Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase
Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)
AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase
Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Tmax and Tlag of Albiglutide in the BE Phase
Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Cmax of Albiglutide in the BE Phase
Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
- +11 more secondary outcomes
Study Arms (2)
process 2 albiglutide
ACTIVE COMPARATORalbiglutide 30mg from process 2 drug substance
process 3 albiglutide
ACTIVE COMPARATORalbiglutide 30mg from process 3 drug substance
Interventions
subcutaneous injection administered once a week
Eligibility Criteria
You may qualify if:
- Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin
- Body mass index ≥20 kg/m2 and ≤45 kg/m2
- Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
- Thyroid-stimulating hormone level is normal or clinically euthyroid
- Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.
You may not qualify if:
- Current ongoing symptomatic biliary disease or history of pancreatitis
- History of significant GI surgery
- Recent clinically significant cardiovascular and/or cerebrovascular disease
- History of human immunodeficiency virus infection
- History of, or current hepatic disease
- History of alcohol or substance abuse
- Female subject is pregnant, lactating, or \<6 weeks postpartum
- History of type 1 diabetes
- Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any GLP-1 agents including albiglutide
- History of, or family history of thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
GSK Investigational Site
Dothan, Alabama, 36301, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Gulfport, Mississippi, 39501, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Greensboro, North Carolina, 27405, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Mason, Ohio, 45040, United States
GSK Investigational Site
Bensalem, Pennsylvania, 19020, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
North Myrtle Beach, South Carolina, 29582, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
McKenzie, Tennessee, 38201, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Irving, Texas, 75039, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78218, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Sugarland, Texas, 77479, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
Lewisburg, West Virginia, 24901, United States
Related Publications (1)
Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
PMID: 25387217DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 23, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 9, 2017
Results First Posted
May 23, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.