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Pharmacokinetics/Pharmacodynamics of Albiglutide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01357889
First received: May 19, 2011
Last updated: May 29, 2014
Last verified: April 2014
Results First Received: April 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Biological: albiglutide (GSK716155)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The enrollment number reflects the 283 participants starting the Multiple-dose Phase.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was comprised of a Screening Period (up to 2 weeks), a Run-in Period (4 weeks), a Treatment Period (TP: 17 weeks), and a Follow-up (8 weeks) Period. The TP had a Single-dose Phase (Bioequivalence [BE] Phase: 28 days) and a 12-week Multiple-dose Phase. In the BE Phase, 186 participants were randomized; 167 received >=1 treatment dose.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Participant Flow for 3 periods

Period 1:   Single-dose Phase (BE Phase: 28 Days)
    Albiglutide Process 2     Albiglutide Process 3  
STARTED     86     81  
COMPLETED     82     79  
NOT COMPLETED     4     2  
Withdrawal by Subject                 2                 1  
Persistent Hyperglycemia                 1                 1  
Physician Decision                 1                 0  

Period 2:   Multiple-dose Phase (MDP) (Overall)
    Albiglutide Process 2     Albiglutide Process 3  
STARTED     141 [1]   142 [1]
COMPLETED     125     126  
NOT COMPLETED     16     16  
Adverse Event                 2                 2  
Noncompliance                 0                 2  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 5                 2  
Physician Decision                 2                 1  
Withdrawn Due to Hyperglycemia                 7                 7  
[1] After completion of the BE Phase, additional participants were randomized to the Overall Phase.

Period 3:   Follow-up Phase (FUP) (8 Weeks)
    Albiglutide Process 2     Albiglutide Process 3  
STARTED     141 [1]   142 [1]
COMPLETED     138     138  
NOT COMPLETED     3     4  
Noncompliance                 1                 0  
Lost to Follow-up                 0                 4  
Withdrawal by Subject                 1                 0  
Hyperglycemia                 1                 0  
[1] All participants who started the MDP entered the FUP, regardless of MDP completion status.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Total Total of all reporting groups

Baseline Measures
    Albiglutide Process 2     Albiglutide Process 3     Total  
Number of Participants  
[units: participants]
  141     142     283  
Age [1]
[units: Years]
Mean ± Standard Deviation
  52.6  ± 11.18     54.4  ± 10.53     53.5  ± 10.88  
Gender [1]
[units: Participants]
     
Female     78     76     154  
Male     63     66     129  
Race/Ethnicity, Customized [1]
[units: Participants]
     
African American/African Heritage     15     20     35  
American Indian or Alaskan Native     0     1     1  
Asian - Central/South Asian Heritage     2     0     2  
Asian - East Asian Heritage     1     2     3  
Asian - South East Asian Heritage     3     1     4  
Native Hawaiian or Other Pacific Islander     0     1     1  
White - White/Caucasian/European Heritage     120     117     237  
[1] Baseline data are reported for participants randomized to the Single- and Multiple-dose Phases (Overall).



  Outcome Measures
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1.  Primary:   Area 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 ]

Measure Type Primary
Measure Title Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase
Measure Description 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.
Time Frame Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  75     74  
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase  
[units: nanograms*hour/milliliter]
Geometric Mean ( Geometric Coefficient of Variation )
  496190.200  
  ( 42% )  
  464985.355  
  ( 40% )  


Statistical Analysis 1 for Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] ANOVA
Ratio of Geometric LSMs (P3:P2) [4] 0.937
90% Confidence Interval ( 0.842 to 1.042 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   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 ]

Measure Type Primary
Measure Title Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase
Measure Description 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.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  85     80  
Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase  
[units: nanograms per milliliter (ng/mL)]
Geometric Mean ( Geometric Coefficient of Variation )
  1881.053  
  ( 58% )  
  1743.053  
  ( 49% )  


Statistical Analysis 1 for Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] ANOVA
Ratio of Geometric LSMs (P3:P2) [4] 0.927
90% Confidence Interval ( 0.813 to 1.056 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   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) ]

Measure Type Secondary
Measure Title Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)
Measure Description The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.
Time Frame Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  136     138  
Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)  
[units: ng/mL]
Mean ± Standard Deviation
   
Week 5, n=131, 135     10.55  ± 34.847     8.70  ± 25.547  
Week 9, n=127, 130     2420.95  ± 1064.204     2519.62  ± 911.794  
Week 13, n=126, 127     2352.94  ± 984.488     2356.27  ± 987.143  
Week 17 (EOT), n=123, 125     2360.19  ± 1005.598     2436.63  ± 1089.381  
Week 25 (follow-up), n=121, 123     28.20  ± 291.287     14.45  ± 160.245  

No statistical analysis provided for Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)



4.  Secondary:   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) ]

Measure Type Secondary
Measure Title Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase
Measure Description The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.
Time Frame Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     142  
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase  
[units: Participants]
   
Baseline, n=139, 140     1     0  
Week 5, n=131, 132     1     0  
Week 9, n=124, 120     0     0  
Week 13, n=119, 122     1     3  
Week 17, n=119, 127     0     5  
Week 25, n=116, 118     0     2  

No statistical analysis provided for Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase



5.  Secondary:   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 ]

Measure Type Secondary
Measure Title AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase
Measure Description The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  85     80  
AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase  
[units: nanograms*hour/milliliter]
Geometric Mean ( Geometric Coefficient of Variation )
   
AUC (0-last), n=84, 80     447294.0  
  ( 55.5% )  
  426263.5  
  ( 45.2% )  
AUC (0-inf), n=75, 74     496190.2  
  ( 41.8% )  
  464985.4  
  ( 39.7% )  

No statistical analysis provided for AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase



6.  Secondary:   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 ]

Measure Type Secondary
Measure Title Tmax and Tlag of Albiglutide in the BE Phase
Measure Description Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  85     80  
Tmax and Tlag of Albiglutide in the BE Phase  
[units: Hours]
Median ( Full Range )
   
tmax, n=85, 80     95.50  
  ( 23.4 to 214.3 )  
  96.08  
  ( 20.5 to 217.8 )  
tlag, n=84, 80     0.00  
  ( 0.0 to 24.1 )  
  0.00  
  ( 0.0 to 24.1 )  

No statistical analysis provided for Tmax and Tlag of Albiglutide in the BE Phase



7.  Secondary:   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 ]

Measure Type Secondary
Measure Title Cmax of Albiglutide in the BE Phase
Measure Description Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  85     80  
Cmax of Albiglutide in the BE Phase  
[units: ng/mL]
Geometric Mean ( Geometric Coefficient of Variation )
  1881.05  
  ( 58.3% )  
  1743.05  
  ( 49.1% )  

No statistical analysis provided for Cmax of Albiglutide in the BE Phase



8.  Secondary:   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 ]

Measure Type Secondary
Measure Title t1/2 of Albiglutide in the BE Phase
Measure Description The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  75     74  
t1/2 of Albiglutide in the BE Phase  
[units: Hours]
Geometric Mean ( Geometric Coefficient of Variation )
  106.42  
  ( 16.3% )  
  113.83  
  ( 22.5% )  

No statistical analysis provided for t1/2 of Albiglutide in the BE Phase



9.  Secondary:   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 ]

Measure Type Secondary
Measure Title Apparent Clearance of Albiglutide in the BE Phase
Measure Description The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  75     74  
Apparent Clearance of Albiglutide in the BE Phase  
[units: Liters per hour]
Geometric Mean ( Geometric Coefficient of Variation )
  0.06046  
  ( 41.8% )  
  0.06452  
  ( 39.7% )  

No statistical analysis provided for Apparent Clearance of Albiglutide in the BE Phase



10.  Secondary:   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 ]

Measure Type Secondary
Measure Title Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase
Measure Description The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.
Time Frame Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  75     74  
Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase  
[units: Liters]
Geometric Mean ( Geometric Coefficient of Variation )
  9.283  
  ( 44.0% )  
  10.595  
  ( 44.3% )  

No statistical analysis provided for Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase



11.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17   [ Time Frame: Baseline and Week 17 ]

Measure Type Secondary
Measure Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17
Measure Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.
Time Frame Baseline and Week 17  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  135     135  
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17  
[units: Percentage of HbA1c in blood]
Least Squares Mean ± Standard Error
  -0.75  ± 0.082     -0.84  ± 0.082  

No statistical analysis provided for Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17



12.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17   [ Time Frame: Baseline and Week 17 ]

Measure Type Secondary
Measure Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17
Measure Description This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.
Time Frame Baseline and Week 17  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy Population - LOCF

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     141  
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17  
[units: millimoles per liter]
Least Squares Mean ± Standard Error
  -1.11  ± 0.231     -1.21  ± 0.231  

No statistical analysis provided for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17



13.  Secondary:   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 ]

Measure Type Secondary
Measure Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Measure Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.
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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     142  
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)  
[units: Participants]
   
Any AE     106     91  
Any SAE     5     1  

No statistical analysis provided for Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)



14.  Secondary:   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 ]

Measure Type Secondary
Measure Title Number of Participants With Indicated Adverse Events of Special Interest
Measure Description Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).
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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     142  
Number of Participants With Indicated Adverse Events of Special Interest  
[units: Participants]
   
Any cardiovascular AE     15     9  
Any hypoglycemic AE     11     7  
Any thyroid AE     2     1  
Any GI AE     36     32  
Any SAR AE     1     0  
Any ISR AE     13     7  
Any hepatobiliary AE     2     2  
Any investigations     5     10  
Any pancreatitis AE     0     0  
Any diabetic retinopathy AE     0     0  

No statistical analysis provided for Number of Participants With Indicated Adverse Events of Special Interest



15.  Secondary:   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 ]

Measure Type Secondary
Measure Title Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit
Measure Description Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a >0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a >25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.
Time Frame Week 1 through Week 25  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  140     140  
Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit  
[units: Participants]
   
Hematocrit >0.1 decrease     1     0  
Hemoglobin >25 g/L     1     1  

No statistical analysis provided for Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit



16.  Secondary:   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 ]

Measure Type Secondary
Measure Title Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit
Measure Description Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase >30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase >20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase >30 beats per minute (bpm) was considered to be of clinical concern.
Time Frame Week 1 through Week 25  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     141  
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit  
[units: Participants]
   
SBP, decrease >30 mmHg     18     16  
SBP, increase >30 mmHg     10     10  
DBP, decrease >20 mmHg     19     16  
DBP, increase >20 mmHg     7     8  
Heart rate, decrease >30 bpm     1     4  
Heart rate, increase >30 bpm     5     4  

No statistical analysis provided for Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit



17.  Secondary:   Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17   [ Time Frame: Screening and Week 17 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17
Measure Description A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.
Time Frame Screening and Week 17  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only participants analyzed at Week 17 are presented.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  120     125  
Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17  
[units: Participants]
   
Skin, Improved     2     3  
Skin, No Change     112     117  
Skin, Worsened     6     4  
Skin, Not done     0     1  
Head, Eyes, ENT, Improved     3     0  
Head, Eyes, ENT, No Change     115     122  
Head, Eyes, ENT, Worsened     2     2  
Head, Eyes, ENT, Not done     0     1  
Cardiovascular system, Improved     1     0  
Cardiovascular system, No Change     119     124  
Cardiovascular system, Worsened     0     0  
Cardiovascular system, Not done     0     1  
Respiratory system, Improved     0     1  
Respiratory system, No Change     120     123  
Respiratory system, Worsened     0     0  
Respiratory system, Not done     0     1  
Abdomen (Liver and Spleen), Improved     0     0  
Abdomen (Liver and Spleen), No Change     120     121  
Abdomen (Liver and Spleen), Worsened     0     3  
Abdomen (Liver and Spleen), Not done     0     1  
Lymph Nodes, Improved     0     0  
Lymph Nodes, No Change     120     123  
Lymph Nodes, Worsened     0     0  
Lymph Nodes, Not done     0     2  
CNS, Improved     1     2  
CNS, No Change     118     122  
CNS, Worsened     1     0  
CNS, Not done     0     1  
Extremities, Improved     4     1  
Extremities, No Change     114     118  
Extremities, Worsened     2     4  
Extremities, Not done     0     2  
Thyroid, Improved     0     0  
Thyroid, No Change     120     123  
Thyroid, Worsened     0     0  
Thyroid, Not done     0     2  

No statistical analysis provided for Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17



18.  Secondary:   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 ]

Measure Type Secondary
Measure Title Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit
Measure Description ECG parameters include heart rate, QRS interval, QTinterval, QT interval – Bazett correction (QTcB), QT interval – Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of >25% when Baseline QRS >100 milliseconds (msec) and an increase of >50% when Baseline QRS <=100 msec was considered to be of clinical concern. For QTcF, a >=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of >25% when Baseline PR >200 msec and an increase of >50% when Baseline PR <=200 msec was considered to be of clinical concern.
Time Frame Week 1 through Week 25  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.

Reporting Groups
  Description
Albiglutide Process 2 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
Albiglutide Process 3 During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.

Measured Values
    Albiglutide Process 2     Albiglutide Process 3  
Number of Participants Analyzed  
[units: participants]
  141     142  
Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit  
[units: Participants]
   
QRS, Increase of > 25% or >50%, n=139, 137     1     0  
QTcF, >=60 msec, n=139, 137     0     0  
PR, Increase of > 25% or >50%, n=137, 135     0     0  

No statistical analysis provided for Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357889     History of Changes
Other Study ID Numbers: 114856
Study First Received: May 19, 2011
Results First Received: April 24, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration