Clincosm LogoSign in Get a demo

Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02683746
Collaborator
(none)
308
Enrollment
70
Locations
2
Arms
14
Actual Duration (Months)
4.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose, study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic response of albiglutide liquid drug product relative to the commercial lyophilized drug product. The study will specifically evaluate the potential for immunogenicity (example [e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).

Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will enable the commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an auto-injector.

The primary hypothesis of this study is to test that liquid drug product will provide glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug product for a period of 26 weeks of treatment in subjects with T2DM.

This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and for those subjects not entering the extension study a follow-up period (8 weeks). Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI); or, Albiglutide lyophilized DCC PI plus Placebo LAI.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lyophilized albiglutide DCC pen injector
  • Drug: Lyophilized albiglutide DCC pen injector matching placebo
  • Drug: Albiglutide liquid auto-injector
  • Drug: Albiglutide liquid auto-injector matching placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
308 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Repeat-dose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product
Actual Study Start Date :
Mar 16, 2016
Actual Primary Completion Date :
Apr 3, 2017
Actual Study Completion Date :
May 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Albiglutide active LAI plus Placebo lyophilized DCC PI

Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.

Drug: Lyophilized albiglutide DCC pen injector matching placebo
A fixed-dose, fully disposable pen injector system with a prefilled DCC containing matching placebo delivering an injection volume of 0.5mL

Drug: Albiglutide liquid auto-injector
A fixed-dose, single use, disposable auto-injector containing albiglutide liquid (30mg or 50mg) in a prefilled glass syringe. The auto-injector delivers the albiglutide liquid in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.
Experimental: Albiglutide lyophilized DCC PI plus Placebo LAI

Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.

Drug: Lyophilized albiglutide DCC pen injector
A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL.

Drug: Albiglutide liquid auto-injector matching placebo
A fixed-dose, single use, disposable auto-injector containing matching placebo in a prefilled glass syringe. The auto-injector delivers the matching placebo in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 [Baseline and Week 26]

    Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.

Secondary Outcome Measures

  1. Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs) [Up to Week 26]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.

  2. Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) [Up to Week 26]

    Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.

  3. Number of Participants With Hematology Parameters of PCC [Up to Week 26]

    Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.

  4. Number of Participants With Vital Signs of PCC [Up to Week 34]

    Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.

  5. Number of Participants With Electrocardiogram (ECG) Parameters of PCC [Up to Week 26]

    Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.

  6. Number of Participants With Positive Result for Anti-albiglutide Antibody [Up to Week 34]

    Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.

  7. Number of Participants With Injection Site Reactions (ISR) [Up to Week 34]

    Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.

  8. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [Baseline and Week 26]

    Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.

  9. Change From Baseline in HbA1c Over Time [Baseline and up to Week 26]

    Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

  10. Change From Baseline in FPG Over Time [Baseline and up to Week 26]

    Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

  11. Trough Plasma Concentration of Albiglutide Over Time [Pre-dose at Week 12 and Week 26]

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18 to 80 years of age inclusive

  • Historical diagnosis of type 2 diabetes mellitus (T2DM) (at least 3 months), experiencing inadequate glycemic control on current regimen of diet and exercise or on a stable maximal tolerated dose of metformin, maintained for approximately 8 weeks prior to screening.

  • HbA1c >=7.0 percent (%) and <=10%.

  • Hemoglobin >=11 grams per deciliter (g/dL) (>=110 grams per liter [g/L]) for males and

=10 g/dL (>=100 g/L) for females.

  • Body mass index <=40 kilograms per squared meter (kg/m^2)

  • Male or female

  • Able and willing to provide informed consent.

Exclusion Criteria:

  • Type 1 diabetes mellitus

  • History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed).

  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

  • History of acute or chronic pancreatitis.

  • History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening.

  • Severe gastroparesis, i.e., requiring regular therapy within 6 months before screening.

  • History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function

  • History of severe hypoglycemia unawareness

  • Diabetic complications or any other clinically significant abnormality .

  • Clinically significant Cardiovascular (CV) and/or cerebrovascular disease within 3 months before screening

  • QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 470 milliseconds (msec).

  • ALT >2.5x upper limit of the normal range (ULN) or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).

  • Estimated glomerular filtration rate (eGFR) <=30 milliliter (mL)/minute (min)/1.73 squared meter (m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at screening.

  • Fasting triglyceride level >750 milligrams per deciliter (mg/dL) at screening.

  • Hemoglobinopathy that may affect proper interpretation of HbA1c.

  • Medical or psychiatric disorders that would preclude effective participation in study.

  • Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization.

  • Use of dipeptidyl peptidase-IV inhibitors within the 3 months before randomization.

  • History of alcohol or substance abuse within one year before screening.

  • Known allergy to albiglutide or any product components (including yeast and human albumin), any other glucagon-like peptide-1 (GLP-1) analogue, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications.

  • A positive pre-study drug/alcohol screen.

  • A positive test for human immunodeficiency virus (HIV) antibody.

  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Birmingham Alabama United States 35216
2 GSK Investigational Site Birmingham Alabama United States 35235
3 GSK Investigational Site Chandler Arizona United States 85224
4 GSK Investigational Site Glendale Arizona United States 85306
5 GSK Investigational Site Phoenix Arizona United States 85018
6 GSK Investigational Site Anaheim California United States 92801
7 GSK Investigational Site Canyon Country California United States 91351
8 GSK Investigational Site Chula Vista California United States 91911
9 GSK Investigational Site Fresno California United States 93720
10 GSK Investigational Site Lomita California United States 90717
11 GSK Investigational Site Oceanside California United States 92056
12 GSK Investigational Site Sacramento California United States 95821
13 GSK Investigational Site San Diego California United States 92120
14 GSK Investigational Site Spring Valley California United States 91978
15 GSK Investigational Site Tustin California United States 92780
16 GSK Investigational Site Van Nuys California United States 91405
17 GSK Investigational Site Walnut Creek California United States 94598
18 GSK Investigational Site Littleton Colorado United States 80128
19 GSK Investigational Site Bradenton Florida United States 34208
20 GSK Investigational Site Brooksville Florida United States 34601
21 GSK Investigational Site Clearwater Florida United States 33765-2616
22 GSK Investigational Site Fleming Island Florida United States 32003
23 GSK Investigational Site Hallandale Beach Florida United States 33009
24 GSK Investigational Site Hialeah Florida United States 33016
25 GSK Investigational Site Miami Florida United States 33156
26 GSK Investigational Site Miami Florida United States 33176
27 GSK Investigational Site New Port Richey Florida United States 34652
28 GSK Investigational Site Orlando Florida United States 32825
29 GSK Investigational Site Saint Petersburg Florida United States 33709
30 GSK Investigational Site Conyers Georgia United States 30094
31 GSK Investigational Site Snellville Georgia United States 30078
32 GSK Investigational Site Meridian Idaho United States 83642
33 GSK Investigational Site Chicago Illinois United States 60612
34 GSK Investigational Site Elgin Illinois United States 60124
35 GSK Investigational Site Evansville Indiana United States 47714
36 GSK Investigational Site Topeka Kansas United States 66606
37 GSK Investigational Site Lexington Kentucky United States 40503
38 GSK Investigational Site Lake Charles Louisiana United States 70601
39 GSK Investigational Site New Orleans Louisiana United States 70119
40 GSK Investigational Site Kalamazoo Michigan United States 49009
41 GSK Investigational Site Troy Michigan United States 48098
42 GSK Investigational Site Chesterfield Missouri United States 63017
43 GSK Investigational Site Saint Louis Missouri United States 63141
44 GSK Investigational Site Las Vegas Nevada United States 89123
45 GSK Investigational Site Albuquerque New Mexico United States 87102
46 GSK Investigational Site New Hyde Park New York United States 11042
47 GSK Investigational Site Greensboro North Carolina United States 27405
48 GSK Investigational Site Shelby North Carolina United States 28150
49 GSK Investigational Site Columbus Ohio United States 43201
50 GSK Investigational Site Maumee Ohio United States 43537-9402
51 GSK Investigational Site Norwood Ohio United States 45212
52 GSK Investigational Site Perrysburg Ohio United States 43551
53 GSK Investigational Site Altoona Pennsylvania United States 16602
54 GSK Investigational Site Anderson South Carolina United States 29621
55 GSK Investigational Site Columbia South Carolina United States 29204
56 GSK Investigational Site Arlington Texas United States 76012
57 GSK Investigational Site Dallas Texas United States 75230
58 GSK Investigational Site Houston Texas United States 77051
59 GSK Investigational Site Houston Texas United States 77058
60 GSK Investigational Site Houston Texas United States 77074
61 GSK Investigational Site Katy Texas United States 77079
62 GSK Investigational Site Pharr Texas United States 78577
63 GSK Investigational Site San Antonio Texas United States 78229
64 GSK Investigational Site San Antonio Texas United States 78231
65 GSK Investigational Site Schertz Texas United States 78154
66 GSK Investigational Site Spring Texas United States 77379
67 GSK Investigational Site Murray Utah United States 84123
68 GSK Investigational Site Federal Way Washington United States 98003
69 GSK Investigational Site Spokane Washington United States 99208
70 GSK Investigational Site Tacoma Washington United States 98405

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02683746
Other Study ID Numbers:
  • 200952
First Posted:
Feb 17, 2016
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Pharmacodynamics
Safety
Albiglutide
Tolerability
Type 2 Diabetes Mellitus
Efficacy
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
rGLP-1 protein
Glucagon-Like Peptide 1

Study Results

Participant Flow

Recruitment Details This repeat-dose study of albiglutide was conducted at 153 sites in the United States (US). A total of 624 participants with type 2 diabetes mellitus (T2DM) were screened; of these 316 were screen failures and 308 were randomized to receive albiglutide liquid drug product or lyophilized drug product in a 1:1 ratio.
Pre-assignment Detail
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Period Title: Overall Study
STARTED 154 154
COMPLETED 138 140
NOT COMPLETED 16 14

Baseline Characteristics

Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized Total
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Total of all reporting groups
Overall Participants 153 154 307
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
57.6
(9.25)
56.6
(10.08)
57.1
(9.67)
Sex: Female, Male (Count of Participants)
Female
70
45.8%
79
51.3%
149
48.5%
Male
83
54.2%
75
48.7%
158
51.5%
Race/Ethnicity, Customized (Count of Participants)
American Indian (AI) or Alaska native Heritage
1
0.7%
3
1.9%
4
1.3%
Asian- Central/ South Asian Heritage
1
0.7%
0
0%
1
0.3%
Asian- Japanese/East Asian (EA)/South EA Heritage
2
1.3%
2
1.3%
4
1.3%
Black or African American (AA) Heritage
15
9.8%
24
15.6%
39
12.7%
Native Hawaiian or Other Pacific Islander Heritage
1
0.7%
1
0.6%
2
0.7%
White Heritage
129
84.3%
122
79.2%
251
81.8%
Multiple- AI or Alaska Native and White Heritage
2
1.3%
1
0.6%
3
1%
Multiple- Black or AA and White Heritage
2
1.3%
1
0.6%
3
1%

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Description Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.
Time Frame Baseline and Week 26

Outcome Measure Data

Analysis Population Description
Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment and have a Baseline assessment.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 154
Least Squares Mean (Standard Error) [Percentage of total hemoglobin]
-1.12
(0.072)
-1.18
(0.072)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Non-Inferiority
Comments The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.
Statistical Test of Hypothesis p-Value 0.0002
Comments P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.13 to 0.24
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)
Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.
Time Frame Up to Week 26

Outcome Measure Data

Analysis Population Description
Safety Population comprised of all enrolled participants who received at least one dose of study treatment.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 154
AEs
101
94
SAEs
7
9
3. Secondary Outcome
Title Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)
Description Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.
Time Frame Up to Week 26

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 153
ALT; >3*ULN
0
0%
1
0.6%
Albumin; >5 g/L below LLN
0
0%
0
0%
Albumin; >5 g/L above ULN
0
0%
0
0%
Alk.phosph.; >3*ULN
0
0%
0
0%
AST; >3*ULN
1
0.7%
1
0.6%
Bilirubin; >1.5*ULN
0
0%
2
1.3%
Calcium; <1.8 mmol/L
0
0%
0
0%
Calcium; >3.0 mmol/L
1
0.7%
0
0%
CO2; <16 mmol/L
1
0.7%
6
3.9%
CO2; >40 mmol/L
0
0%
0
0%
Creatinine; >159 µmol/L
1
0.7%
1
0.6%
Direct bilirubin; >1.35ULN
0
0%
1
0.6%
GGT; >3*ULN
1
0.7%
4
2.6%
Potassium; >0.5 mmol/L below LLN
0
0%
1
0.6%
Potassium; >1.0 mmol/L above ULN
0
0%
1
0.6%
Protein; >15 g/L below LLN
0
0%
0
0%
Protein; >15 g/L above ULN
0
0%
0
0%
Sodium; >5 mmol/L below LLN
1
0.7%
0
0%
Sodium; >5 mmol/L above ULN
0
0%
2
1.3%
Urate; >654 µmol/L
1
0.7%
1
0.6%
Urea; >2*ULN
0
0%
0
0%
4. Secondary Outcome
Title Number of Participants With Hematology Parameters of PCC
Description Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.
Time Frame Up to Week 26

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 153
Hematocrit; >0.05 (fraction of 1) below LLN
2
1.3%
6
3.9%
Hematocrit; >0.04 (fraction of 1) above ULN
5
3.3%
2
1.3%
Hb; >20 g/L below LLN
3
2%
9
5.8%
Hb; >10 g/L above ULN
2
1.3%
2
1.3%
Lymphocytes; <0.5*LLN
0
0%
0
0%
Neutrophils; <1 GI/L
1
0.7%
0
0%
Platelets; <80 GI/L
0
0%
0
0%
Platelets; >500 GI/L
1
0.7%
1
0.6%
5. Secondary Outcome
Title Number of Participants With Vital Signs of PCC
Description Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.
Time Frame Up to Week 34

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 153
SBP: <100 mmHg
18
11.8%
16
10.4%
SBP; >170 mmHg
11
7.2%
13
8.4%
DBP; <50 mmHg
0
0%
0
0%
DBP; > 110 mmHg
3
2%
3
1.9%
Pulse rate; < 50 bpm
5
3.3%
2
1.3%
Pulse rate; > 120 bpm
1
0.7%
0
0%
6. Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Parameters of PCC
Description Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.
Time Frame Up to Week 26

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 152 152
ECG mean heart rate; <50 bpm
2
1.3%
2
1.3%
ECG mean heart rate; >120 bpm
1
0.7%
0
0%
PR interval; >300 msec
1
0.7%
2
1.3%
QRS duration; >200 msec
0
0%
0
0%
QTcF interval; >=500 msec
0
0%
0
0%
7. Secondary Outcome
Title Number of Participants With Positive Result for Anti-albiglutide Antibody
Description Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.
Time Frame Up to Week 34

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 152 152
Number [Participants]
17
11.1%
16
10.4%
8. Secondary Outcome
Title Number of Participants With Injection Site Reactions (ISR)
Description Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.
Time Frame Up to Week 34

Outcome Measure Data

Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 154
Number [Participants]
17
11.1%
18
11.7%
9. Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.
Time Frame Baseline and Week 26

Outcome Measure Data

Analysis Population Description
ITT Population. Only those participants available at Week 26 were analyzed.
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 141 136
Least Squares Mean (Standard Error) [Mmol/L]
-2.22
(0.191)
-1.88
(0.195)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.83 to 0.14
Parameter Dispersion Type:
Value:
Estimation Comments
10. Secondary Outcome
Title Change From Baseline in HbA1c Over Time
Description Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 26

Outcome Measure Data

Analysis Population Description
ITT Population
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 154
Week 4; n= 148, 149
-0.50
(0.045)
-0.54
(0.046)
Week 8; 145, 147
-0.96
(0.057)
-1.02
(0.057)
Week 12; n= 137, 145
-1.15
(0.065)
-1.23
(0.064)
Week 16; n= 136, 144
-1.25
(0.070)
-1.27
(0.070)
Week 20; n= 137, 142
-1.24
(0.067)
-1.26
(0.066)
Week 26; n= 138, 141
-1.16
(0.071)
-1.17
(0.071)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.07 to 0.13
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.07 to 0.20
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.08 to 0.24
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.16 to 0.20
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.15 to 0.19
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.
Method MMRM model
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.17 to 0.20
Parameter Dispersion Type:
Value:
Estimation Comments Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.
11. Secondary Outcome
Title Change From Baseline in FPG Over Time
Description Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 26

Outcome Measure Data

Analysis Population Description
ITT Population
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 153 154
Week 1; n= 148, 144
-1.04
(0.165)
-1.29
(0.167)
Week 2; n= 143, 145
-1.52
(0.180)
-1.77
(0.181)
Week 3; n= 145, 140
-1.71
(0.168)
-1.70
(0.170)
Week 4; n= 142, 145
-1.93
(0.162)
-1.91
(0.164)
Week 5; n= 146, 143
-2.04
(0.160)
-2.23
(0.162)
Week 6; n= 145, 145
-2.07
(0.167)
-2.22
(0.169)
Week 7; n= 146, 144
-1.93
(0.176)
-2.20
(0.179)
Week 8; n= 143, 141
-2.19
(0.169)
-2.38
(0.171)
Week 9; n= 142, 141
-2.05
(0.178)
-2.08
(0.180)
Week 10; n= 141, 142
-2.03
(0.173)
-2.17
(0.175)
Week 11; n= 141, 139
-2.01
(0.181)
-2.12
(0.184)
Week 12; n= 137, 137
-2.16
(0.176)
-2.19
(0.178)
Week 13; n= 140, 136
-2.04
(0.202)
-2.09
(0.205)
Week 16; n= 140, 140
-2.02
(0.189)
-2.09
(0.191)
Week 20; n= 139, 134
-1.87
(0.197)
-1.90
(0.201)
Week 26; n= 141, 136
-2.22
(0.191)
-1.88
(0.195)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.15 to 0.65
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.20 to 0.69
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.42 to 0.40
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.42 to 0.36
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.19 to 0.57
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.26 to 0.55
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.16 to 0.71
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.22 to 0.60
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.41 to 0.47
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.28 to 0.57
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.34 to 0.56
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.41 to 0.46
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.47 to 0.57
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.41 to 0.54
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.47 to 0.53
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Albiglutide Liquid, Albiglutide Lyophilized
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.83 to 0.14
Parameter Dispersion Type:
Value:
Estimation Comments Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.
12. Secondary Outcome
Title Trough Plasma Concentration of Albiglutide Over Time
Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Pre-dose at Week 12 and Week 26

Outcome Measure Data

Analysis Population Description
PK Population
Arm/Group Title Albiglutide Liquid Albiglutide Lyophilized
Arm/Group Description Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period. Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Measure Participants 151 149
Week 12; n= 127, 130
3996.9
(1613.02)
3927.1
(1537.45)
Week 26; n= 127, 127
4196.6
(1500.57)
3929.1
(1338.08)

Adverse Events

Time Frame On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26.
Adverse Event Reporting Description On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Arm/Group Title Albiglutide Active LAI Plus Placebo Lyophilized DCC PI Albiglutide Lyophilized DCC PI Plus Placebo LAI
Arm/Group Description Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm. Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
All Cause Mortality
Albiglutide Active LAI Plus Placebo Lyophilized DCC PI Albiglutide Lyophilized DCC PI Plus Placebo LAI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/153 (0%) 0/154 (0%)
Serious Adverse Events
Albiglutide Active LAI Plus Placebo Lyophilized DCC PI Albiglutide Lyophilized DCC PI Plus Placebo LAI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/153 (4.6%) 9/154 (5.8%)
Cardiac disorders
Angina pectoris 1/153 (0.7%) 0/154 (0%)
Coronary artery disease 0/153 (0%) 1/154 (0.6%)
Supraventricular tachycardia 0/153 (0%) 1/154 (0.6%)
Gastrointestinal disorders
Pancreatitis acute 0/153 (0%) 1/154 (0.6%)
General disorders
Chest pain 0/153 (0%) 1/154 (0.6%)
Hepatobiliary disorders
Cholelithiasis 0/153 (0%) 1/154 (0.6%)
Infections and infestations
Diverticulitis 0/153 (0%) 1/154 (0.6%)
Pneumonia 0/153 (0%) 1/154 (0.6%)
Injury, poisoning and procedural complications
Spinal compression fracture 1/153 (0.7%) 0/154 (0%)
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis 0/153 (0%) 1/154 (0.6%)
Musculoskeletal chest pain 0/153 (0%) 1/154 (0.6%)
Osteoarthritis 0/153 (0%) 1/154 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 1/153 (0.7%) 0/154 (0%)
Spindle cell sarcoma 1/153 (0.7%) 0/154 (0%)
Squamous cell carcinoma of skin 1/153 (0.7%) 0/154 (0%)
Nervous system disorders
Syncope 0/153 (0%) 1/154 (0.6%)
Respiratory, thoracic and mediastinal disorders
Asthma 1/153 (0.7%) 0/154 (0%)
Chronic obstructive pulmonary disease 1/153 (0.7%) 0/154 (0%)
Other (Not Including Serious) Adverse Events
Albiglutide Active LAI Plus Placebo Lyophilized DCC PI Albiglutide Lyophilized DCC PI Plus Placebo LAI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 101/153 (66%) 94/154 (61%)
Blood and lymphatic system disorders
Anaemia 1/153 (0.7%) 2/154 (1.3%)
Lymphadenopathy 0/153 (0%) 1/154 (0.6%)
Cardiac disorders
Coronary artery disease 1/153 (0.7%) 0/154 (0%)
Left ventricular hypertrophy 0/153 (0%) 1/154 (0.6%)
Mitral valve calcification 1/153 (0.7%) 0/154 (0%)
Sinus bradycardia 0/153 (0%) 1/154 (0.6%)
Ventricular tachycardia 1/153 (0.7%) 0/154 (0%)
Ear and labyrinth disorders
Motion sickness 0/153 (0%) 1/154 (0.6%)
Tinnitus 0/153 (0%) 1/154 (0.6%)
Eye disorders
Cataract 1/153 (0.7%) 1/154 (0.6%)
Age-related macular degeneration 0/153 (0%) 1/154 (0.6%)
Blepharitis 0/153 (0%) 1/154 (0.6%)
Conjunctival haemorrhage 0/153 (0%) 1/154 (0.6%)
Erythema of eyelid 0/153 (0%) 1/154 (0.6%)
Gastrointestinal disorders
Nausea 17/153 (11.1%) 25/154 (16.2%)
Diarrhoea 15/153 (9.8%) 11/154 (7.1%)
Constipation 13/153 (8.5%) 2/154 (1.3%)
Vomiting 6/153 (3.9%) 6/154 (3.9%)
Toothache 4/153 (2.6%) 6/154 (3.9%)
Abdominal pain 2/153 (1.3%) 6/154 (3.9%)
Abdominal distension 4/153 (2.6%) 3/154 (1.9%)
Abdominal discomfort 1/153 (0.7%) 3/154 (1.9%)
Abdominal pain upper 1/153 (0.7%) 3/154 (1.9%)
Gastrooesophageal reflux disease 2/153 (1.3%) 2/154 (1.3%)
Flatulence 1/153 (0.7%) 2/154 (1.3%)
Dental caries 1/153 (0.7%) 1/154 (0.6%)
Dyspepsia 0/153 (0%) 2/154 (1.3%)
Eructation 1/153 (0.7%) 1/154 (0.6%)
Gastritis 0/153 (0%) 2/154 (1.3%)
Abdominal hernia 1/153 (0.7%) 0/154 (0%)
Epigastric discomfort 0/153 (0%) 1/154 (0.6%)
Inguinal hernia 1/153 (0.7%) 0/154 (0%)
Irritable bowel syndrome 0/153 (0%) 1/154 (0.6%)
Rectal haemorrhage 0/153 (0%) 1/154 (0.6%)
Tongue ulceration 1/153 (0.7%) 0/154 (0%)
Tooth impacted 1/153 (0.7%) 0/154 (0%)
General disorders
Injection site reaction 6/153 (3.9%) 6/154 (3.9%)
Injection site bruising 3/153 (2%) 5/154 (3.2%)
Injection site erythema 1/153 (0.7%) 7/154 (4.5%)
Injection site pruritus 2/153 (1.3%) 5/154 (3.2%)
Injection site rash 3/153 (2%) 3/154 (1.9%)
Fatigue 2/153 (1.3%) 3/154 (1.9%)
Pyrexia 1/153 (0.7%) 2/154 (1.3%)
Oedema peripheral 0/153 (0%) 2/154 (1.3%)
Asthenia 1/153 (0.7%) 0/154 (0%)
Inflammation 1/153 (0.7%) 0/154 (0%)
Injection site discolouration 0/153 (0%) 1/154 (0.6%)
Injection site haematoma 1/153 (0.7%) 0/154 (0%)
Injection site haemorrhage 1/153 (0.7%) 0/154 (0%)
Injection site induration 0/153 (0%) 1/154 (0.6%)
Injection site irritation 1/153 (0.7%) 0/154 (0%)
Injection site pain 0/153 (0%) 1/154 (0.6%)
Injection site swelling 0/153 (0%) 1/154 (0.6%)
Malaise 1/153 (0.7%) 0/154 (0%)
Non-cardiac chest pain 1/153 (0.7%) 0/154 (0%)
Peripheral swelling 0/153 (0%) 1/154 (0.6%)
Vaccination site bruising 0/153 (0%) 1/154 (0.6%)
Vessel puncture site haematoma 0/153 (0%) 1/154 (0.6%)
Vessel puncture site reaction 0/153 (0%) 1/154 (0.6%)
Hepatobiliary disorders
Cholangitis 0/153 (0%) 1/154 (0.6%)
Immune system disorders
Seasonal allergy 2/153 (1.3%) 5/154 (3.2%)
Food allergy 1/153 (0.7%) 0/154 (0%)
Infections and infestations
Upper respiratory tract infection 8/153 (5.2%) 20/154 (13%)
Viral upper respiratory tract infection 10/153 (6.5%) 10/154 (6.5%)
Bronchitis 3/153 (2%) 5/154 (3.2%)
Urinary tract infection 2/153 (1.3%) 5/154 (3.2%)
Gastroenteritis 3/153 (2%) 2/154 (1.3%)
Sinusitis 1/153 (0.7%) 4/154 (2.6%)
Viral infection 4/153 (2.6%) 0/154 (0%)
Conjunctivitis 1/153 (0.7%) 2/154 (1.3%)
Influenza 2/153 (1.3%) 1/154 (0.6%)
Otitis externa 1/153 (0.7%) 2/154 (1.3%)
Tooth abscess 2/153 (1.3%) 1/154 (0.6%)
Tooth infection 2/153 (1.3%) 1/154 (0.6%)
Localised infection 0/153 (0%) 2/154 (1.3%)
Pneumonia 1/153 (0.7%) 1/154 (0.6%)
Respiratory tract infection 1/153 (0.7%) 1/154 (0.6%)
Abscess limb 0/153 (0%) 1/154 (0.6%)
Acarodermatitis 0/153 (0%) 1/154 (0.6%)
Acute sinusitis 0/153 (0%) 1/154 (0.6%)
Cellulitis 1/153 (0.7%) 0/154 (0%)
Folliculitis 1/153 (0.7%) 0/154 (0%)
Gastroenteritis viral 1/153 (0.7%) 0/154 (0%)
Gingivitis 1/153 (0.7%) 0/154 (0%)
Groin abscess 0/153 (0%) 1/154 (0.6%)
Herpes simplex 0/153 (0%) 1/154 (0.6%)
Incision site abscess 0/153 (0%) 1/154 (0.6%)
Laryngitis 0/153 (0%) 1/154 (0.6%)
Oral herpes 0/153 (0%) 1/154 (0.6%)
Otitis media 0/153 (0%) 1/154 (0.6%)
Otitis media chronic 0/153 (0%) 1/154 (0.6%)
Papilloma viral infection 1/153 (0.7%) 0/154 (0%)
Pharyngitis 0/153 (0%) 1/154 (0.6%)
Pharyngitis streptococcal 0/153 (0%) 1/154 (0.6%)
Post procedural infection 1/153 (0.7%) 0/154 (0%)
Respiratory tract infection viral 1/153 (0.7%) 0/154 (0%)
Rhinitis 1/153 (0.7%) 0/154 (0%)
Sepsis 0/153 (0%) 1/154 (0.6%)
Subcutaneous abscess 0/153 (0%) 1/154 (0.6%)
Vaginal abscess 0/153 (0%) 1/154 (0.6%)
Viraemia 1/153 (0.7%) 0/154 (0%)
Vulvovaginal candidiasis 1/153 (0.7%) 0/154 (0%)
Injury, poisoning and procedural complications
Arthropod bite 2/153 (1.3%) 3/154 (1.9%)
Contusion 0/153 (0%) 5/154 (3.2%)
Fall 0/153 (0%) 4/154 (2.6%)
Laceration 1/153 (0.7%) 3/154 (1.9%)
Limb injury 1/153 (0.7%) 2/154 (1.3%)
Ligament sprain 2/153 (1.3%) 0/154 (0%)
Muscle strain 0/153 (0%) 2/154 (1.3%)
Abdominal injury 0/153 (0%) 1/154 (0.6%)
Arthropod sting 1/153 (0.7%) 0/154 (0%)
Burns second degree 1/153 (0.7%) 0/154 (0%)
Extradural haematoma 0/153 (0%) 1/154 (0.6%)
Facial bones fracture 1/153 (0.7%) 0/154 (0%)
Joint injury 1/153 (0.7%) 0/154 (0%)
Patella fracture 0/153 (0%) 1/154 (0.6%)
Procedural complication 0/153 (0%) 1/154 (0.6%)
Skin abrasion 0/153 (0%) 1/154 (0.6%)
Skin injury 0/153 (0%) 1/154 (0.6%)
Skull fractured base 0/153 (0%) 1/154 (0.6%)
Tendon injury 0/153 (0%) 1/154 (0.6%)
Wrist fracture 0/153 (0%) 1/154 (0.6%)
Investigations
Gamma-glutamyltransferase increased 1/153 (0.7%) 0/154 (0%)
Heart sounds abnormal 0/153 (0%) 1/154 (0.6%)
Liver function test increased 0/153 (0%) 1/154 (0.6%)
Metabolism and nutrition disorders
Decreased appetite 5/153 (3.3%) 6/154 (3.9%)
Type 2 diabetes mellitus 2/153 (1.3%) 1/154 (0.6%)
Gout 0/153 (0%) 1/154 (0.6%)
Hyperglycaemia 1/153 (0.7%) 0/154 (0%)
Hyperphagia 1/153 (0.7%) 0/154 (0%)
Hypokalaemia 0/153 (0%) 1/154 (0.6%)
Hypovolaemia 0/153 (0%) 1/154 (0.6%)
Vitamin D deficiency 0/153 (0%) 1/154 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia 6/153 (3.9%) 3/154 (1.9%)
Back pain 4/153 (2.6%) 5/154 (3.2%)
Neck pain 3/153 (2%) 3/154 (1.9%)
Musculoskeletal pain 2/153 (1.3%) 3/154 (1.9%)
Pain in extremity 3/153 (2%) 1/154 (0.6%)
Muscle spasms 3/153 (2%) 0/154 (0%)
Myalgia 2/153 (1.3%) 1/154 (0.6%)
Arthritis 0/153 (0%) 2/154 (1.3%)
Exostosis 0/153 (0%) 2/154 (1.3%)
Intervertebral disc degeneration 0/153 (0%) 2/154 (1.3%)
Osteoarthritis 1/153 (0.7%) 1/154 (0.6%)
Flank pain 0/153 (0%) 1/154 (0.6%)
Intervertebral disc protrusion 0/153 (0%) 1/154 (0.6%)
Joint effusion 0/153 (0%) 1/154 (0.6%)
Joint range of motion decreased 0/153 (0%) 1/154 (0.6%)
Musculoskeletal chest pain 0/153 (0%) 1/154 (0.6%)
Neuropathic arthropathy 0/153 (0%) 1/154 (0.6%)
Osteoporosis 1/153 (0.7%) 0/154 (0%)
Pain in jaw 0/153 (0%) 1/154 (0.6%)
Plantar fasciitis 1/153 (0.7%) 0/154 (0%)
Rotator cuff syndrome 0/153 (0%) 1/154 (0.6%)
Tendon sheath disorder 0/153 (0%) 1/154 (0.6%)
Tendonitis 0/153 (0%) 1/154 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer 1/153 (0.7%) 0/154 (0%)
Nervous system disorders
Headache 12/153 (7.8%) 14/154 (9.1%)
Dizziness 6/153 (3.9%) 6/154 (3.9%)
Neuropathy peripheral 3/153 (2%) 0/154 (0%)
Diabetic neuropathy 0/153 (0%) 1/154 (0.6%)
Dysgeusia 0/153 (0%) 1/154 (0.6%)
Migraine 0/153 (0%) 1/154 (0.6%)
Nerve compression 0/153 (0%) 1/154 (0.6%)
Paraesthesia 1/153 (0.7%) 0/154 (0%)
Periodic limb movement disorder 0/153 (0%) 1/154 (0.6%)
Sciatica 0/153 (0%) 1/154 (0.6%)
Tension headache 0/153 (0%) 1/154 (0.6%)
Psychiatric disorders
Depression 1/153 (0.7%) 3/154 (1.9%)
Insomnia 1/153 (0.7%) 2/154 (1.3%)
Anxiety 1/153 (0.7%) 1/154 (0.6%)
Attention deficit/hyperactivity disorder 0/153 (0%) 1/154 (0.6%)
Binge eating 0/153 (0%) 1/154 (0.6%)
Borderline personality disorder 0/153 (0%) 1/154 (0.6%)
Libido decreased 1/153 (0.7%) 0/154 (0%)
Renal and urinary disorders
Bladder spasm 0/153 (0%) 1/154 (0.6%)
Reproductive system and breast disorders
Breast tenderness 0/153 (0%) 1/154 (0.6%)
Erectile dysfunction 0/153 (0%) 1/154 (0.6%)
Oligomenorrhoea 1/153 (0.7%) 0/154 (0%)
Vaginal haemorrhage 0/153 (0%) 1/154 (0.6%)
Respiratory, thoracic and mediastinal disorders
Cough 4/153 (2.6%) 5/154 (3.2%)
Oropharyngeal pain 3/153 (2%) 5/154 (3.2%)
Sinus congestion 2/153 (1.3%) 4/154 (2.6%)
Paranasal sinus discomfort 1/153 (0.7%) 2/154 (1.3%)
Asthma 1/153 (0.7%) 1/154 (0.6%)
Lower respiratory tract congestion 0/153 (0%) 2/154 (1.3%)
Rhinitis allergic 1/153 (0.7%) 1/154 (0.6%)
Rhinorrhoea 0/153 (0%) 2/154 (1.3%)
Allergic bronchitis 0/153 (0%) 1/154 (0.6%)
Allergic sinusitis 1/153 (0.7%) 0/154 (0%)
Dyspnoea 0/153 (0%) 1/154 (0.6%)
Epistaxis 0/153 (0%) 1/154 (0.6%)
Nasal congestion 0/153 (0%) 1/154 (0.6%)
Pharyngeal ulceration 1/153 (0.7%) 0/154 (0%)
Sleep apnoea syndrome 1/153 (0.7%) 0/154 (0%)
Tonsillar hypertrophy 0/153 (0%) 1/154 (0.6%)
Upper-airway cough syndrome 1/153 (0.7%) 0/154 (0%)
Vasomotor rhinitis 1/153 (0.7%) 0/154 (0%)
Skin and subcutaneous tissue disorders
Rash 2/153 (1.3%) 2/154 (1.3%)
Dermatitis contact 2/153 (1.3%) 1/154 (0.6%)
Alopecia 1/153 (0.7%) 0/154 (0%)
Dermatitis allergic 1/153 (0.7%) 0/154 (0%)
Diabetic ulcer 0/153 (0%) 1/154 (0.6%)
Erythema 1/153 (0.7%) 0/154 (0%)
Ingrowing nail 1/153 (0.7%) 0/154 (0%)
Intertrigo 0/153 (0%) 1/154 (0.6%)
Lichen planus 1/153 (0.7%) 0/154 (0%)
Night sweats 1/153 (0.7%) 0/154 (0%)
Rash erythematous 0/153 (0%) 1/154 (0.6%)
Rash macular 0/153 (0%) 1/154 (0.6%)
Rash maculo-papular 0/153 (0%) 1/154 (0.6%)
Skin lesion 1/153 (0.7%) 0/154 (0%)
Skin mass 1/153 (0.7%) 0/154 (0%)
Vascular disorders
Hypertension 8/153 (5.2%) 7/154 (4.5%)
Hot flush 1/153 (0.7%) 0/154 (0%)
Hypotension 0/153 (0%) 1/154 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02683746
Other Study ID Numbers:
  • 200952
First Posted:
Feb 17, 2016
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019