Trial Outcomes & Findings for Pharmacokinetics/Pharmacodynamics of Albiglutide (NCT NCT01357889)

Last Updated: 2017-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

283 participants

Primary outcome timeframe

Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Results posted on

2017-01-09

Participant Flow

The enrollment number reflects the 283 participants starting the Multiple-dose Phase.

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.

Participant milestones

Participant milestones
Measure	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.
Single-dose Phase (BE Phase: 28 Days) STARTED	86	81
Single-dose Phase (BE Phase: 28 Days) COMPLETED	82	79
Single-dose Phase (BE Phase: 28 Days) NOT COMPLETED	4	2
Multiple-dose Phase (MDP) (Overall) STARTED	141	142
Multiple-dose Phase (MDP) (Overall) COMPLETED	125	126
Multiple-dose Phase (MDP) (Overall) NOT COMPLETED	16	16
Follow-up Phase (FUP) (8 Weeks) STARTED	141	142
Follow-up Phase (FUP) (8 Weeks) COMPLETED	138	138
Follow-up Phase (FUP) (8 Weeks) NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Single-dose Phase (BE Phase: 28 Days) Withdrawal by Subject	2	1
Single-dose Phase (BE Phase: 28 Days) Persistent Hyperglycemia	1	1
Single-dose Phase (BE Phase: 28 Days) Physician Decision	1	0
Multiple-dose Phase (MDP) (Overall) Adverse Event	2	2
Multiple-dose Phase (MDP) (Overall) Noncompliance	0	2
Multiple-dose Phase (MDP) (Overall) Lost to Follow-up	0	2
Multiple-dose Phase (MDP) (Overall) Withdrawal by Subject	5	2
Multiple-dose Phase (MDP) (Overall) Physician Decision	2	1
Multiple-dose Phase (MDP) (Overall) Withdrawn Due to Hyperglycemia	7	7
Follow-up Phase (FUP) (8 Weeks) Noncompliance	1	0
Follow-up Phase (FUP) (8 Weeks) Lost to Follow-up	0	4
Follow-up Phase (FUP) (8 Weeks) Withdrawal by Subject	1	0
Follow-up Phase (FUP) (8 Weeks) Hyperglycemia	1	0

Baseline Characteristics

Pharmacokinetics/Pharmacodynamics of Albiglutide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albiglutide Process 2 n=141 Participants 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 n=142 Participants 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 n=283 Participants Total of all reporting groups
Age, Continuous	52.6 Years STANDARD_DEVIATION 11.18 • n=5 Participants	54.4 Years STANDARD_DEVIATION 10.53 • n=7 Participants	53.5 Years STANDARD_DEVIATION 10.88 • n=5 Participants
Gender Female	78 Participants n=5 Participants	76 Participants n=7 Participants	154 Participants n=5 Participants
Gender Male	63 Participants n=5 Participants	66 Participants n=7 Participants	129 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	120 Participants n=5 Participants	117 Participants n=7 Participants	237 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=75 Participants 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 n=74 Participants 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.
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 nanograms*hour/milliliter Geometric Coefficient of Variation 42	464985.355 nanograms*hour/milliliter Geometric Coefficient of Variation 40

PRIMARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=85 Participants 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 n=80 Participants 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.
Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase	1881.053 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 58	1743.053 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49

SECONDARY outcome

Timeframe: Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)

Population: 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.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=142 Participants 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.
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Baseline, n=139, 140	1 Participants	0 Participants
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Week 5, n=131, 132	1 Participants	0 Participants
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Week 9, n=124, 120	0 Participants	0 Participants
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Week 13, n=119, 122	1 Participants	3 Participants
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Week 17, n=119, 127	0 Participants	5 Participants
Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase Week 25, n=116, 118	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=85 Participants 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 n=80 Participants 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.
AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase AUC (0-last), n=84, 80	447294.0 nanograms*hour/milliliter Geometric Coefficient of Variation 55.5	426263.5 nanograms*hour/milliliter Geometric Coefficient of Variation 45.2
AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase AUC (0-inf), n=75, 74	496190.2 nanograms*hour/milliliter Geometric Coefficient of Variation 41.8	464985.4 nanograms*hour/milliliter Geometric Coefficient of Variation 39.7

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=85 Participants 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 n=80 Participants 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.
Tmax and Tlag of Albiglutide in the BE Phase tmax, n=85, 80	95.50 Hours Interval 23.4 to 214.3	96.08 Hours Interval 20.5 to 217.8
Tmax and Tlag of Albiglutide in the BE Phase tlag, n=84, 80	0.00 Hours Interval 0.0 to 24.1	0.00 Hours Interval 0.0 to 24.1

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=85 Participants 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 n=80 Participants 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.
Cmax of Albiglutide in the BE Phase	1881.05 ng/mL Geometric Coefficient of Variation 58.3	1743.05 ng/mL Geometric Coefficient of Variation 49.1

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=75 Participants 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 n=74 Participants 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.
t1/2 of Albiglutide in the BE Phase	106.42 Hours Geometric Coefficient of Variation 16.3	113.83 Hours Geometric Coefficient of Variation 22.5

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=75 Participants 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 n=74 Participants 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.
Apparent Clearance of Albiglutide in the BE Phase	0.06046 Liters per hour Geometric Coefficient of Variation 41.8	0.06452 Liters per hour Geometric Coefficient of Variation 39.7

SECONDARY outcome

Timeframe: Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Population: Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=75 Participants 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 n=74 Participants 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.
Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase	9.283 Liters Geometric Coefficient of Variation 44.0	10.595 Liters Geometric Coefficient of Variation 44.3

SECONDARY outcome

Timeframe: Baseline and Week 17

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=135 Participants 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 n=135 Participants 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17	-0.75 Percentage of HbA1c in blood Standard Error 0.082	-0.84 Percentage of HbA1c in blood Standard Error 0.082

SECONDARY outcome

Timeframe: Baseline and Week 17

Population: Efficacy Population - LOCF

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=141 Participants 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.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17	-1.11 millimoles per liter Standard Error 0.231	-1.21 millimoles per liter Standard Error 0.231

SECONDARY outcome

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

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=142 Participants 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.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any AE	106 Participants	91 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any SAE	5 Participants	1 Participants

SECONDARY outcome

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

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=142 Participants 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.
Number of Participants With Indicated Adverse Events of Special Interest Any cardiovascular AE	15 Participants	9 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any hypoglycemic AE	11 Participants	7 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any thyroid AE	2 Participants	1 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any GI AE	36 Participants	32 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any SAR AE	1 Participants	0 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any ISR AE	13 Participants	7 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any hepatobiliary AE	2 Participants	2 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any investigations	5 Participants	10 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any pancreatitis AE	0 Participants	0 Participants
Number of Participants With Indicated Adverse Events of Special Interest Any diabetic retinopathy AE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1 through Week 25

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=140 Participants 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 n=140 Participants 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.
Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit Hematocrit >0.1 decrease	1 Participants	0 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit Hemoglobin >25 g/L	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 1 through Week 25

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=141 Participants 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.
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit SBP, decrease >30 mmHg	18 Participants	16 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit SBP, increase >30 mmHg	10 Participants	10 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit DBP, decrease >20 mmHg	19 Participants	16 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit DBP, increase >20 mmHg	7 Participants	8 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit Heart rate, decrease >30 bpm	1 Participants	4 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit Heart rate, increase >30 bpm	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Screening and Week 17

Population: Safety Population. Only participants analyzed at Week 17 are presented.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: Week 1 through Week 25

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Albiglutide Process 2 n=141 Participants 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 n=142 Participants 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.
Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit QRS, Increase of > 25% or >50%, n=139, 137	1 Participants	0 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit QTcF, >=60 msec, n=139, 137	0 Participants	0 Participants
Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit PR, Increase of > 25% or >50%, n=137, 135	0 Participants	0 Participants

Adverse Events

Albiglutide Process 2

Serious events: 5 serious events

Other events: 84 other events

Deaths: 0 deaths

Albiglutide Process 3

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Albiglutide Process 2 n=141 participants at risk 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 n=142 participants at risk 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.
Hepatobiliary disorders Cholecystitis	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.70% 1/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
General disorders Chest pain	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
General disorders Device malfunction	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Concussion	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.
Nervous system disorders Subarachnoid haemorrhage	0.71% 1/141 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.	0.00% 0/142 • On-therapy SAEs/non-serious AEs (onset on/after study drug start date and within 56 days after last dose) were collected from time of study participation consent through Week 25/final follow-up visit for par. who discontinued active study participation. SAEs and non-serious AEs are reported for members of the Single- and Multiple-dose Phases Safety Population, comprised of all participants who received at least 1 dose of study medication.

Other adverse events

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