A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Biological: albiglutide; Drug: liraglutide

Detailed Description

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

• Study Type: Interventional
• Enrollment (Actual): 841
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2606
      • GSK Investigational Site
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • GSK Investigational Site
    • St Leonards, New South Wales, Australia, 2065
      • GSK Investigational Site
  • Queensland
    • Herston, Queensland, Australia, 4029
      • GSK Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • GSK Investigational Site
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
    • Heidelberg, Victoria, Australia, 3081
      • GSK Investigational Site
    • Ringwood East, Victoria, Australia, 3135
      • GSK Investigational Site
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • GSK Investigational Site
• Israel
  • Beer-Sheva, Israel, 84101
    • GSK Investigational Site
  • Haifa, Israel, 35251
    • GSK Investigational Site
  • Kfar Saba, Israel, 44281
    • GSK Investigational Site
  • Nahariya, Israel, 22100
    • GSK Investigational Site
• Korea, Republic of
  • Goyang, Korea, Republic of, 414410
    • GSK Investigational Site
  • Seongnam-si, Korea, Republic of, 463712
    • GSK Investigational Site
  • Seongnam-si,, Korea, Republic of, 463-707
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 136-705
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 139-872
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135720
    • GSK Investigational Site
• Peru
  • Ica, Peru, 11
    • GSK Investigational Site
  • Lima, Peru, Lima 1
    • GSK Investigational Site
  • Lima, Peru, 01
    • GSK Investigational Site
  • Lima, Peru, 17
    • GSK Investigational Site
  • Piura, Peru
    • GSK Investigational Site
  • Lima
    • Callao, Lima, Peru, Callao 2
      • GSK Investigational Site
    • Huacho, Lima, Peru
      • GSK Investigational Site
• Philippines
  • Cebu City, Philippines, 6000
    • GSK Investigational Site
  • Iloilo City, Philippines, 5000
    • GSK Investigational Site
  • Makati City, Philippines, 1218
    • GSK Investigational Site
  • Marikina City, Philippines, 1810
    • GSK Investigational Site
  • Pasay, Philippines, 1300
    • GSK Investigational Site
  • Pasig, Philippines, 1600
    • GSK Investigational Site
  • Pasig City, Philippines, 1600
    • GSK Investigational Site
• Spain
  • Alicante, Spain, 03114
    • GSK Investigational Site
  • La Coruña, Spain, 15006
    • GSK Investigational Site
  • Majadahonda (Madrid), Spain, 28222
    • GSK Investigational Site
  • Modulo H, Spain, 07120
    • GSK Investigational Site
  • Sabadell, Spain, 08208
    • GSK Investigational Site
  • Torrevieja (Alicante), Spain, 03186
    • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • GSK Investigational Site
  • Hertfordshire, United Kingdom
    • GSK Investigational Site
  • Livingston, United Kingdom, EH54 6PP
    • GSK Investigational Site
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
  • Swansea, United Kingdom, SA6 6NL
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • GSK Investigational Site
    • Gilbert, Arizona, United States, 85295
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85032
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85712
      • GSK Investigational Site
  • Arkansas
    • Searcy, Arkansas, United States, 72143
      • GSK Investigational Site
  • California
    • Chula Vista, California, United States, 91910
      • GSK Investigational Site
    • Escondido, California, United States, 92026
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92648
      • GSK Investigational Site
    • Indio, California, United States, 92201
      • GSK Investigational Site
    • Irvine, California, United States, 92618
      • GSK Investigational Site
    • Los Angeles, California, United States, 90017
      • GSK Investigational Site
    • Los Angeles, California, United States, 90022
      • GSK Investigational Site
    • Mission Viejo, California, United States, 92691
      • GSK Investigational Site
    • Orange, California, United States, 92868
      • GSK Investigational Site
    • Palm Desert, California, United States, 92260
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • San Diego, California, United States, 92128
      • GSK Investigational Site
    • Satna Monica, California, United States, 90404
      • GSK Investigational Site
    • Spring Valley, California, United States, 91978
      • GSK Investigational Site
    • Tarzana, California, United States, 91356
      • GSK Investigational Site
    • Tustin, California, United States, 92780
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
    • West Hills, California, United States, 91307
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • GSK Investigational Site
    • Cocoa, Florida, United States, 32927
      • GSK Investigational Site
    • Miami, Florida, United States, 33156
      • GSK Investigational Site
    • North Miami, Florida, United States, 33161
      • GSK Investigational Site
    • Ocala, Florida, United States, 34471
      • GSK Investigational Site
    • Orlando, Florida, United States, 32822
      • GSK Investigational Site
    • Pembroke Pines, Florida, United States, 33026
      • GSK Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
    • Winter Park, Florida, United States, 32789
      • GSK Investigational Site
    • Winter Park, Florida, United States, 32792
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30309
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30312
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30338
      • GSK Investigational Site
    • Blue Ridge, Georgia, United States, 30513
      • GSK Investigational Site
    • Roswell, Georgia, United States, 30076
      • GSK Investigational Site
    • Stone Mountain, Georgia, United States, 30088
      • GSK Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • GSK Investigational Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • GSK Investigational Site
  • Illinois
    • La Grange, Illinois, United States, 60525
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • GSK Investigational Site
    • Valparaiso, Indiana, United States, 46383
      • GSK Investigational Site
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • GSK Investigational Site
    • Dubuque, Iowa, United States, 52001
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • GSK Investigational Site
    • Paducah, Kentucky, United States, 42003
      • GSK Investigational Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71101
      • GSK Investigational Site
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • GSK Investigational Site
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • GSK Investigational Site
    • Dearborn, Michigan, United States, 48124
      • GSK Investigational Site
    • Detroit, Michigan, United States, 48235
      • GSK Investigational Site
    • Kalamazoo, Michigan, United States, 49009
      • GSK Investigational Site
    • Kalamazoo, Michigan, United States, 49048
      • GSK Investigational Site
    • St Clair Shores, Michigan, United States, 48081
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55430
      • GSK Investigational Site
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63141
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • GSK Investigational Site
    • Las Vegas, Nevada, United States, 89103
      • GSK Investigational Site
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • GSK Investigational Site
    • Haddon Heights, New Jersey, United States, 08035
      • GSK Investigational Site
  • New York
    • North Massapequa, New York, United States, 11758
      • GSK Investigational Site
    • Staten Island, New York, United States, 10301
      • GSK Investigational Site
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
    • Greensboro, North Carolina, United States, 27405
      • GSK Investigational Site
    • Lenoir, North Carolina, United States, 28645
      • GSK Investigational Site
    • Morehead City, North Carolina, United States, 28557
      • GSK Investigational Site
    • Shelby, North Carolina, United States, 28150
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Canal Fulton, Ohio, United States, 44614
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44122
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43213
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45439
      • GSK Investigational Site
    • Gallipolis, Ohio, United States, 45631
      • GSK Investigational Site
    • Kettering, Ohio, United States, 45429
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • GSK Investigational Site
  • Pennsylvania
    • Downington, Pennsylvania, United States, 19335
      • GSK Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
    • Murrells Inlet, South Carolina, United States, 29576
      • GSK Investigational Site
    • Simpsonville, South Carolina, United States, 29681
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Clarksville, Tennessee, United States, 37043
      • GSK Investigational Site
    • Memphis, Tennessee, United States, 38125
      • GSK Investigational Site
    • Tullahoma, Tennessee, United States, 37398
      • GSK Investigational Site
  • Texas
    • Arlington, Texas, United States, 76012
      • GSK Investigational Site
    • Corpus Christi, Texas, United States, 78404
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Dallas, Texas, United States, 75251
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77036
      • GSK Investigational Site
    • Houston, Texas, United States, 77074
      • GSK Investigational Site
    • Houston, Texas, United States, 77088
      • GSK Investigational Site
    • Hurst, Texas, United States, 76054
      • GSK Investigational Site
    • Katy, Texas, United States, 77450
      • GSK Investigational Site
    • Midland, Texas, United States, 79707
      • GSK Investigational Site
    • North Richland Hills, Texas, United States, 76180
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78215
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78217
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78237
      • GSK Investigational Site
    • Schertz, Texas, United States, 78154
      • GSK Investigational Site
    • Sugarland, Texas, United States, 77479
      • GSK Investigational Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • GSK Investigational Site
    • Draper, Utah, United States, 84020
      • GSK Investigational Site
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • GSK Investigational Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • GSK Investigational Site
    • Manassas, Virginia, United States, 20110
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23294
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23225
      • GSK Investigational Site
    • Salem, Virginia, United States, 24153
      • GSK Investigational Site
  • Washington
    • Spokane, Washington, United States, 99216
      • GSK Investigational Site
    • Spokane, Washington, United States, 99208
      • GSK Investigational Site
    • Tacoma, Washington, United States, 98405
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
• BMI >/=20kg/m2 and </=45 kg/m2
• Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
• HbA1c between 7.0% and 10.0%, inclusive
• Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

• History of cancer
• History of treated diabetic gastroparesis
• Current biliary disease or history of pancreatitis
• History of significant GI surgery
• Recent clinically significant cardiovascular and/or cerebrovascular disease
• Hypertension
• History of human immunodeficiency virus infection
• History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
• History of alcohol or substance abuse
• Female subject is pregnant, lactating, or <6 weeks postpartum
• Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
• History of type 1 diabetes mellitus
• Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
• Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
• History or family history of thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: albiglutide; weekly albiglutide subcutaneous injection	Biological: albiglutide; albiglutide weekly subcutaneous injection
ACTIVE_COMPARATOR: liraglutide; liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.	Drug: liraglutide; liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.	Baseline, Weeks 4, 6, 12, 18 and 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.	Baseline and Week 32
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.	Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32	Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Week 32
Time to Hyperglycemia Rescue at Week 32	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.	Week 32
Mean Change From Baseline in Body Weight at Week 32	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.	Baseline and Week 32

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6. Erratum In: Lancet Diabetes Endocrinol. 2014 Mar;2(3):e5.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (ESTIMATE): May 24, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: open-label; albiglutide; liraglutide; GSK716155
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; rGLP-1 protein
• Other Study ID Numbers: 114179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: 114179
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register