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Pharmacokinetics/Pharmacodynamics of Albiglutide
A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide
Lead sponsor
Asset
Albiglutide
Subcutaneous · GLP-1 agonist
Listed sites
30
Recruiting sites
—
Enrollment
283
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI 20-45
Primary endpoints
•AUC•Cmax of Albiglutide in the BE Phase
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
2 endpointsChange From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17
Time frame:Baseline and Week 17
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), Percentage of HbA1c in blood | 95% CI |
|---|---|---|
| Albiglutide Process 2 | -0.75 | — |
| Albiglutide Process 3 | -0.84 | — |
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17
Time frame:Baseline and Week 17
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), millimoles per liter | 95% CI |
|---|---|---|
| Albiglutide Process 2 | -1.11 | — |
| Albiglutide Process 3 | -1.21 | — |
Safety / tolerability / PK
16 endpointsArea Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase
Time frame:Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms*hour/milliliter | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 496190.200 | — |
| Albiglutide Process 3 | 464985.355 | — |
Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms per milliliter (ng/mL) | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 1881.053 | — |
| Albiglutide Process 3 | 1743.053 | — |
Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)
Time frame:Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Value (mean), ng/mL | 95% CI |
|---|---|---|
| Albiglutide Process 2Week 5, n=131, 135 | 10.55 | — |
| Week 9, n=127, 130 | 2420.95 | — |
| Week 13, n=126, 127 | 2352.94 | — |
| Week 17 (EOT), n=123, 125 | 2360.19 | — |
| Week 25 (follow-up), n=121, 123 | 28.20 | — |
| Albiglutide Process 3Week 5, n=131, 135 | 8.70 | — |
| Week 9, n=127, 130 | 2519.62 | — |
| Week 13, n=126, 127 | 2356.27 | — |
| Week 17 (EOT), n=123, 125 | 2436.63 | — |
| Week 25 (follow-up), n=121, 123 | 14.45 | — |
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase
Time frame:Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)
Immunogenicity (ADA)
descriptive
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2Baseline, n=139, 140 | 1 | — |
| Week 5, n=131, 132 | 1 | — |
| Week 9, n=124, 120 | 0 | — |
| Week 13, n=119, 122 | 1 | — |
| Week 17, n=119, 127 | 0 | — |
| Week 25, n=116, 118 | 0 | — |
| Albiglutide Process 3Baseline, n=139, 140 | 0 | — |
| Week 5, n=131, 132 | 0 | — |
| Week 9, n=124, 120 | 0 | — |
| Week 13, n=119, 122 | 3 | — |
| Week 17, n=119, 127 | 5 | — |
| Week 25, n=116, 118 | 2 | — |
AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms*hour/milliliter | 95% CI |
|---|---|---|
| Albiglutide Process 2AUC (0-last), n=84, 80 | 447294.0 | — |
| AUC (0-inf), n=75, 74 | 496190.2 | — |
| Albiglutide Process 3AUC (0-last), n=84, 80 | 426263.5 | — |
| AUC (0-inf), n=75, 74 | 464985.4 | — |
Tmax and Tlag of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Tmax
descriptive
Posted result
| Group | Value (median), Hours | 95% CI |
|---|---|---|
| Albiglutide Process 2tmax, n=85, 80 | 95.50 | 23.4 – 214.3 |
| tlag, n=84, 80 | 0.00 | 0.0 – 24.1 |
| Albiglutide Process 3tmax, n=85, 80 | 96.08 | 20.5 – 217.8 |
| tlag, n=84, 80 | 0.00 | 0.0 – 24.1 |
Cmax of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 1881.05 | — |
| Albiglutide Process 3 | 1743.05 | — |
t1/2 of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
Half-life
descriptive
Posted result
| Group | Value (geometric_mean), Hours | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 106.42 | — |
| Albiglutide Process 3 | 113.83 | — |
Apparent Clearance of Albiglutide in the BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
descriptive
Posted result
| Group | Value (geometric_mean), Liters per hour | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 0.06046 | — |
| Albiglutide Process 3 | 0.06452 | — |
Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase
Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose
descriptive
Posted result
| Group | Value (geometric_mean), Liters | 95% CI |
|---|---|---|
| Albiglutide Process 2 | 9.283 | — |
| Albiglutide Process 3 | 10.595 | — |
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: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
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2Any AE | 106 | — |
| Any SAE | 5 | — |
| Albiglutide Process 3Any AE | 91 | — |
| Any SAE | 1 | — |
Number of Participants With Indicated Adverse Events of Special Interest
Time frame: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
event count, event
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2Any cardiovascular AE | 15 | — |
| Any hypoglycemic AE | 11 | — |
| Any thyroid AE | 2 | — |
| Any GI AE | 36 | — |
| Any SAR AE | 1 | — |
| Any ISR AE | 13 | — |
| Any hepatobiliary AE | 2 | — |
| Any investigations | 5 | — |
| Any pancreatitis AE | 0 | — |
| Any diabetic retinopathy AE | 0 | — |
| Albiglutide Process 3Any cardiovascular AE | 9 | — |
| Any hypoglycemic AE | 7 | — |
| Any thyroid AE | 1 | — |
| Any GI AE | 32 | — |
| Any SAR AE | 0 | — |
| Any ISR AE | 7 | — |
| Any hepatobiliary AE | 2 | — |
| Any investigations | 10 | — |
| Any pancreatitis AE | 0 | — |
| Any diabetic retinopathy AE | 0 | — |
Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit
Time frame:Week 1 through Week 25
threshold achievement, event
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2Hematocrit >0.1 decrease | 1 | — |
| Hemoglobin >25 g/L | 1 | — |
| Albiglutide Process 3Hematocrit >0.1 decrease | 0 | — |
| Hemoglobin >25 g/L | 1 | — |
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit
Time frame:Week 1 through Week 25
threshold achievement, event
componentsSystolic BP, change, Diastolic BP, change, Heart rate, change
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2SBP, decrease >30 mmHg | 18 | — |
| SBP, increase >30 mmHg | 10 | — |
| DBP, decrease >20 mmHg | 19 | — |
| DBP, increase >20 mmHg | 7 | — |
| Heart rate, decrease >30 bpm | 1 | — |
| Heart rate, increase >30 bpm | 5 | — |
| Albiglutide Process 3SBP, decrease >30 mmHg | 16 | — |
| SBP, increase >30 mmHg | 10 | — |
| DBP, decrease >20 mmHg | 16 | — |
| DBP, increase >20 mmHg | 8 | — |
| Heart rate, decrease >30 bpm | 4 | — |
| Heart rate, increase >30 bpm | 4 | — |
Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17
Time frame:Screening and Week 17
categorical status, descriptive
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2Skin, Improved | 2 | — |
| Skin, No Change | 112 | — |
| Skin, Worsened | 6 | — |
| Skin, Not done | 0 | — |
| Head, Eyes, ENT, Improved | 3 | — |
| Head, Eyes, ENT, No Change | 115 | — |
| Head, Eyes, ENT, Worsened | 2 | — |
| Head, Eyes, ENT, Not done | 0 | — |
| Cardiovascular system, Improved | 1 | — |
| Cardiovascular system, No Change | 119 | — |
| Cardiovascular system, Worsened | 0 | — |
| Cardiovascular system, Not done | 0 | — |
| Respiratory system, Improved | 0 | — |
| Respiratory system, No Change | 120 | — |
| Respiratory system, Worsened | 0 | — |
| Respiratory system, Not done | 0 | — |
| Abdomen (Liver and Spleen), Improved | 0 | — |
| Abdomen (Liver and Spleen), No Change | 120 | — |
| Abdomen (Liver and Spleen), Worsened | 0 | — |
| Abdomen (Liver and Spleen), Not done | 0 | — |
| Lymph Nodes, Improved | 0 | — |
| Lymph Nodes, No Change | 120 | — |
| Lymph Nodes, Worsened | 0 | — |
| Lymph Nodes, Not done | 0 | — |
| CNS, Improved | 1 | — |
| CNS, No Change | 118 | — |
| CNS, Worsened | 1 | — |
| CNS, Not done | 0 | — |
| Extremities, Improved | 4 | — |
| Extremities, No Change | 114 | — |
| Extremities, Worsened | 2 | — |
| Extremities, Not done | 0 | — |
| Thyroid, Improved | 0 | — |
| Thyroid, No Change | 120 | — |
| Thyroid, Worsened | 0 | — |
| Thyroid, Not done | 0 | — |
| Albiglutide Process 3Skin, Improved | 3 | — |
| Skin, No Change | 117 | — |
| Skin, Worsened | 4 | — |
| Skin, Not done | 1 | — |
| Head, Eyes, ENT, Improved | 0 | — |
| Head, Eyes, ENT, No Change | 122 | — |
| Head, Eyes, ENT, Worsened | 2 | — |
| Head, Eyes, ENT, Not done | 1 | — |
| Cardiovascular system, Improved | 0 | — |
| Cardiovascular system, No Change | 124 | — |
| Cardiovascular system, Worsened | 0 | — |
| Cardiovascular system, Not done | 1 | — |
| Respiratory system, Improved | 1 | — |
| Respiratory system, No Change | 123 | — |
| Respiratory system, Worsened | 0 | — |
| Respiratory system, Not done | 1 | — |
| Abdomen (Liver and Spleen), Improved | 0 | — |
| Abdomen (Liver and Spleen), No Change | 121 | — |
| Abdomen (Liver and Spleen), Worsened | 3 | — |
| Abdomen (Liver and Spleen), Not done | 1 | — |
| Lymph Nodes, Improved | 0 | — |
| Lymph Nodes, No Change | 123 | — |
| Lymph Nodes, Worsened | 0 | — |
| Lymph Nodes, Not done | 2 | — |
| CNS, Improved | 2 | — |
| CNS, No Change | 122 | — |
| CNS, Worsened | 0 | — |
| CNS, Not done | 1 | — |
| Extremities, Improved | 1 | — |
| Extremities, No Change | 118 | — |
| Extremities, Worsened | 4 | — |
| Extremities, Not done | 2 | — |
| Thyroid, Improved | 0 | — |
| Thyroid, No Change | 123 | — |
| Thyroid, Worsened | 0 | — |
| Thyroid, Not done | 2 | — |
Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit
Time frame:Week 1 through Week 25
threshold achievement, event
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Albiglutide Process 2QRS, Increase of > 25% or >50%, n=139, 137 | 1 | — |
| QTcF, >=60 msec, n=139, 137 | 0 | — |
| PR, Increase of > 25% or >50%, n=137, 135 | 0 | — |
| Albiglutide Process 3QRS, Increase of > 25% or >50%, n=139, 137 | 0 | — |
| QTcF, >=60 msec, n=139, 137 | 0 | — |
| PR, Increase of > 25% or >50%, n=137, 135 | 0 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.