Phase 2
Completed N=167
Pharmacokinetics/Pharmacodynamics of Albiglutide
Source: ClinicalTrials.gov NCT01357889 ↗Enrolled (actual)
167
Serious AEs
2.1%
Results posted
May 2014
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase — 496190.200; 464985.355 nanograms*hour/milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase |
496190.200; 464985.355 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase |
1881.053; 1743.053 | — |
| SECONDARY Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP) |
10.55; 8.70; 2420.95; 2519.62; 2352.94; 2356.27 | — |
| SECONDARY Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase |
447294.0; 426263.5; 496190.2; 464985.4 | — |
| SECONDARY Tmax and Tlag of Albiglutide in the BE Phase |
95.50; 96.08; 0.00; 0.00 | — |
| SECONDARY Cmax of Albiglutide in the BE Phase |
1881.05; 1743.05 | — |
| SECONDARY t1/2 of Albiglutide in the BE Phase |
106.42; 113.83 | — |
| SECONDARY Apparent Clearance of Albiglutide in the BE Phase |
0.06046; 0.06452 | — |
| SECONDARY Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase |
9.283; 10.595 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17 |
-0.75; -0.84 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17 |
-1.11; -1.21 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) |
106; 91; 5; 1 | — |
| SECONDARY Number of Participants With Indicated Adverse Events of Special Interest |
15; 9; 11; 7; 2; 1 | — |
| SECONDARY Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit |
1; 0; 1; 1 | — |
| SECONDARY Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit |
18; 16; 10; 10; 19; 16 | — |
| SECONDARY Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17 |
2; 3; 112; 117; 6; 4 | — |
| SECONDARY Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit |
1; 0; 0; 0; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01357889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.