Pharmacokinetics/pharmacodynamics of albiglutide
Trial overview
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
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
Participation 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
- Current ongoing symptomatic biliary disease or history of pancreatitis
- History of significant GI surgery
- 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.
- 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)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.