Last updated: 11/07/2018 08:20:36
Pharmacokinetics/pharmacodynamics of albiglutide
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multidose study in subjects with type 2 diabetes mellitus to assess the pharmacokinetics and pharmacodynamics of albiglutide
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Area under the plasma concentration versus time curve (AUC) from time zero to infinity (0-inf) of albiglutide in the Bioequivalence (BE) Phase
Timeframe: 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
Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Secondary outcomes:
Trough (pre-dose) plasma concentrations of albiglutide in the Mutiple-dose Phase (MDP)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
t1/2 of albiglutide in the BE Phase
Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Apparent clearance of albiglutide in the BE Phase
Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Apparent volume of distribution in the terminal phase of albiglutide in BE Phase
Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 17
Timeframe: Baseline and Week 17
Change from Baseline in fasting plasma glucose (FPG) at Week 17
Timeframe: Baseline and Week 17
Number of participants with any adverse event (AE) or serious adverse event (SAE)
Timeframe: From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study
Number of participants with indicated adverse events of special interest
Timeframe: From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study
Number of participants with a change from Baseline of clinical concern in hematology values by any on-therapy visit
Timeframe: Week 1 through Week 25
Number of participants with a change from Baseline of clinical concern in vital signs by any on-therapy visit
Timeframe: Week 1 through Week 25
Number of participants with the indicated change from the Screening assessment in physical examination at Week 17
Timeframe: Screening and Week 17
Number of participants with a change from Baseline of clinical concern in electrocardiogram (ECG) values by any on-therapy visit
Timeframe: Week 1 through Week 25
Interventions:
Biological/vaccine: albiglutide (GSK716155)
Enrollment:
283
Observational study model:
Not applicable
Primary completion date:
2012-31-10
Time perspective:
Not applicable
Clinical publications:
Malcolm A. Young, Jeffrey A. Wald Jessica E. Matthews, Rhona Scott, Hui Zhi, Rebecca Hodge, Rickey R. Reinhardt. Clinical Pharmacokinetics and Pharmacodynamics of Albiglutide, a GLP-1 Receptor Agonist . Postgrad Med. 2014;7:84-97.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
July 2011 to October 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- 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
- Current ongoing symptomatic biliary disease or history of pancreatitis
- History of significant GI surgery
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Bountiful, Utah, United States, 84010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42003
Status
Will Be Recruiting
Location
GSK Investigational Site
McKenzie, Tennessee, United States, 38201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Will Be Recruiting
Location
GSK Investigational Site
Gulfport, Mississippi, United States, 39501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, Texas, United States, 77074
Status
Will Be Recruiting
Location
GSK Investigational Site
Columbus, Ohio, United States, 43213
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lewisburg, West Virginia, United States, 24901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Myrtle Beach, South Carolina, United States, 29582
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mason, Ohio, United States, 45040
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27405
Status
Study Complete
Location
GSK Investigational Site
Dothan, Alabama, United States, 36301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78218
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Picayune, Mississippi, United States, 39466
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
2012-31-10
Actual study completion date
2012-31-10
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website