Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

November 18, 2016 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- - Cuernavaca, Mexico, 62250
    - GSK Investigational Site
  - Distrito Federal, Mexico, 06700
    - GSK Investigational Site
  - Guadalajara, Mexico, 44600
    - GSK Investigational Site
  - Guadalajara, Mexico, 44680
    - GSK Investigational Site
  - Mexico City, Mexico, 03300
    - GSK Investigational Site
  - Mexico City, Mexico, 11570
    - GSK Investigational Site
  - Nezahualcoyotl, Mexico, 57170
    - GSK Investigational Site
  - Puebla, Mexico, 72190
    - GSK Investigational Site
  - Torreón, Mexico, 27000
    - GSK Investigational Site
- Baja California Norte
  - Tijuana, Baja California Norte, Mexico, 22010
    - GSK Investigational Site
- Hidalgo
  - Pachuca, Hidalgo, Mexico, 42086
    - GSK Investigational Site
- Jalisco
  - Zapopan, Jalisco, Mexico, 45200
    - GSK Investigational Site
- Michoacán
  - Morelia, Michoacán, Mexico, C.P. 58249
    - GSK Investigational Site
- Yucatán
  - Merida, Yucatán, Mexico, 97000
    - GSK Investigational Site
South Africa
- - Parow, South Africa, 7505
    - GSK Investigational Site
United States
- Alabama
  - Alabaster, Alabama, United States, 35007
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35235
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35242
    - GSK Investigational Site
  - Dothan, Alabama, United States, 36301
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85225
    - GSK Investigational Site
  - Gilbert, Arizona, United States, 85295
    - GSK Investigational Site
  - Green Valley, Arizona, United States, 85614
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85051
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85745
    - GSK Investigational Site
- Arkansas
  - Bull Shoals, Arkansas, United States, 72619
    - GSK Investigational Site
  - Hot Springs, Arkansas, United States, 71913
    - GSK Investigational Site
  - Jonesboro, Arkansas, United States, 72401
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
  - Searcy, Arkansas, United States, 72143
    - GSK Investigational Site
- California
  - Carmichael, California, United States, 95608
    - GSK Investigational Site
  - Chula Vista, California, United States, 91910
    - GSK Investigational Site
  - Foothill Ranch, California, United States, 92610
    - GSK Investigational Site
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92648
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92646
    - GSK Investigational Site
  - Indio, California, United States, 92201
    - GSK Investigational Site
  - Irvine, California, United States, 92618
    - GSK Investigational Site
  - Lakewood, California, United States, 90712
    - GSK Investigational Site
  - Long Beach, California, United States, 90806
    - GSK Investigational Site
  - Los Alamitos, California, United States, 90720
    - GSK Investigational Site
  - Los Angeles, California, United States, 90025
    - 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
  - Northridge, California, United States, 91325
    - GSK Investigational Site
  - Palm Desert, California, United States, 92260
    - GSK Investigational Site
  - Pasadena, California, United States, 91105
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - Sacramento, California, United States, 95825
    - GSK Investigational Site
  - San Diego, California, United States, 92120
    - GSK Investigational Site
  - San Diego, California, United States, 92117
    - GSK Investigational Site
  - San Diego, California, United States, 92128
    - GSK Investigational Site
  - San Diego, California, United States, 92177
    - GSK Investigational Site
  - Santa Ana, California, United States, 92701
    - 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
  - Torrance, California, United States, 90503
    - GSK Investigational Site
  - Victorville, California, United States, 92395
    - GSK Investigational Site
  - Vista, California, United States, 92083
    - GSK Investigational Site
  - Walnut Creek, California, United States, 94598
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
- Colorado
  - Arvada, Colorado, United States, 80005
    - GSK Investigational Site
- Connecticut
  - New Britain, Connecticut, United States, 06050
    - GSK Investigational Site
- Delaware
  - Middletown, Delaware, United States, 19709
    - GSK Investigational Site
- Florida
  - Clearwater, Florida, United States, 33756
    - GSK Investigational Site
  - Cocoa, Florida, United States, 32927
    - GSK Investigational Site
  - Cutler Bay, Florida, United States, 33189
    - GSK Investigational Site
  - Deerfield Beach, Florida, United States, 33442
    - GSK Investigational Site
  - Delray Beach, Florida, United States, 33445
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33316
    - GSK Investigational Site
  - Hallandale Beach, Florida, United States, 33009
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33012
    - GSK Investigational Site
  - Hollywood, Florida, United States, 33023
    - GSK Investigational Site
  - Lauderdale Lakes, Florida, United States, 33319
    - GSK Investigational Site
  - Marianna, Florida, United States, 32446
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Orlando, Florida, United States, 32822
    - GSK Investigational Site
  - Ormond Beach, Florida, United States, 32174
    - GSK Investigational Site
  - Oviedo, Florida, United States, 32765
    - GSK Investigational Site
  - Panama City, Florida, United States, 32401
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33027
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33026
    - GSK Investigational Site
  - Plantation, Florida, United States, 33317
    - GSK Investigational Site
  - St. Cloud, Florida, United States, 34769
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33401
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30312
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30308
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30338
    - GSK Investigational Site
  - Blue Ridge, Georgia, United States, 30513
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30032
    - GSK Investigational Site
  - Savannah, Georgia, United States, 31419
    - GSK Investigational Site
  - Savannah, Georgia, United States, 31406
    - GSK Investigational Site
  - Snellville, Georgia, United States, 30078
    - GSK Investigational Site
  - Tucker, Georgia, United States, 30084
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - GSK Investigational Site
  - Honolulu, Hawaii, United States, 96814
    - GSK Investigational Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60607
    - GSK Investigational Site
  - Evergreen Park, Illinois, United States, 60805
    - GSK Investigational Site
  - La Grange, Illinois, United States, 60525
    - GSK Investigational Site
  - Naperville, Illinois, United States, 60564
    - GSK Investigational Site
  - Peoria, Illinois, United States, 61602
    - GSK Investigational Site
- Indiana
  - Avon, Indiana, United States, 46123
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46254
    - GSK Investigational Site
  - La Porte, Indiana, United States, 46350
    - GSK Investigational Site
  - South Bend, Indiana, United States, 46614
    - GSK Investigational Site
- Iowa
  - Council Bluffs, Iowa, United States, 51501
    - GSK Investigational Site
  - Dubuque, Iowa, United States, 52001
    - GSK Investigational Site
  - Iowa City, Iowa, United States, 52243
    - GSK Investigational Site
  - Waterloo, Iowa, United States, 50701
    - GSK Investigational Site
- Kansas
  - Arkansas City, Kansas, United States, 67005
    - GSK Investigational Site
  - Newton, Kansas, United States, 67114
    - GSK Investigational Site
  - Overland Park, Kansas, United States, 66211
    - GSK Investigational Site
  - Topeka, Kansas, United States, 66606
    - GSK Investigational Site
- Kentucky
  - Crescent Springs, Kentucky, United States, 41017
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40504
    - GSK Investigational Site
  - Madisonville, Kentucky, United States, 42431
    - GSK Investigational Site
  - Paducah, Kentucky, United States, 42003
    - GSK Investigational Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - GSK Investigational Site
  - Lake Charles, Louisiana, United States, 70601
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71101
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71115
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21237-3998
    - GSK Investigational Site
  - Oxon Hill, Maryland, United States, 20745
    - GSK Investigational Site
- Massachusetts
  - Haverhill, Massachusetts, United States, 01830
    - GSK Investigational Site
- Michigan
  - Bay City, Michigan, United States, 48708
    - GSK Investigational Site
  - Benzonia, Michigan, United States, 49616
    - GSK Investigational Site
  - Dearborn, Michigan, United States, 48124
    - GSK Investigational Site
  - Interlochen, Michigan, United States, 49643
    - 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
- Mississippi
  - Picayune, Mississippi, United States, 39466
    - GSK Investigational Site
  - Rolling Fork, Mississippi, United States, 39159
    - GSK Investigational Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - GSK Investigational Site
  - Jefferson City, Missouri, United States, 65109
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64111
    - GSK Investigational Site
  - Springfield, Missouri, United States, 65807
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63141
    - GSK Investigational Site
  - West Plains, Missouri, United States, 65775
    - GSK Investigational Site
- Montana
  - Great Falls, Montana, United States, 59405
    - GSK Investigational Site
- Nebraska
  - Broken Bow, Nebraska, United States, 68822
    - GSK Investigational Site
  - Lincoln, Nebraska, United States, 68516
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68131
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68134
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89103
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89128
    - GSK Investigational Site
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - GSK Investigational Site
  - Elizabeth, New Jersey, United States, 07202
    - GSK Investigational Site
  - Haddon Heights, New Jersey, United States, 08035
    - GSK Investigational Site
  - Hainesport, New Jersey, United States, 08036
    - GSK Investigational Site
  - Stratford, New Jersey, United States, 08084
    - GSK Investigational Site
- New York
  - North Massapequa, New York, United States, 11758
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - GSK Investigational Site
  - Burlington, North Carolina, United States, 27215
    - GSK Investigational Site
  - Calabash, North Carolina, United States, 28467
    - GSK Investigational Site
  - Chadbourn, North Carolina, United States, 28431
    - GSK Investigational Site
  - Fayetteville, North Carolina, United States, 28304
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27455
    - GSK Investigational Site
  - Hickory, North Carolina, United States, 28601
    - GSK Investigational Site
  - Lenoir, North Carolina, United States, 28645
    - GSK Investigational Site
  - Mint Hill, North Carolina, United States, 28227
    - GSK Investigational Site
  - Morehead City, North Carolina, United States, 28557
    - GSK Investigational Site
  - Shelby, North Carolina, United States, 28150
    - GSK Investigational Site
  - Tabor City, North Carolina, United States, 28463
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, United States, 44320
    - GSK Investigational Site
  - 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
  - Dayton, Ohio, United States, 45432
    - GSK Investigational Site
  - Kettering, Ohio, United States, 45429
    - GSK Investigational Site
  - Mason, Ohio, United States, 45040
    - GSK Investigational Site
  - Maumee, Ohio, United States, 43537-9402
    - GSK Investigational Site
  - Thornville, Ohio, United States, 43076
    - GSK Investigational Site
  - Zanesville, Ohio, United States, 43701
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74104
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74136
    - GSK Investigational Site
- Oregon
  - Ashland, Oregon, United States, 97520
    - GSK Investigational Site
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - GSK Investigational Site
  - Downington, Pennsylvania, United States, 19335
    - GSK Investigational Site
  - Harrisburg, Pennsylvania, United States, 17112
    - GSK Investigational Site
  - Lansdale, Pennsylvania, United States, 19446
    - GSK Investigational Site
  - Melrose Park, Pennsylvania, United States, 19027
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - GSK Investigational Site
  - Tipton, Pennsylvania, United States, 16684
    - GSK Investigational Site
  - Uniontown, Pennsylvania, United States, 15401
    - GSK Investigational Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - GSK Investigational Site
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29615
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29601
    - GSK Investigational Site
  - Greer, South Carolina, United States, 29651
    - GSK Investigational Site
  - Murrells Inlet, South Carolina, United States, 29576
    - GSK Investigational Site
  - North Myrtle Beach, South Carolina, United States, 29582
    - GSK Investigational Site
  - Orangeburg, South Carolina, United States, 29115
    - GSK Investigational Site
  - Simpsonville, South Carolina, United States, 29681
    - GSK Investigational Site
  - Taylors, South Carolina, United States, 29687
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - GSK Investigational Site
  - Clarksville, Tennessee, United States, 37043
    - GSK Investigational Site
  - Columbia, Tennessee, United States, 38401
    - GSK Investigational Site
  - Crossville, Tennessee, United States, 38555
    - GSK Investigational Site
  - Johnson City, Tennessee, United States, 37604
    - GSK Investigational Site
  - McKenzie, Tennessee, United States, 38201
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
  - Tullahoma, Tennessee, United States, 37388
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76012
    - GSK Investigational Site
  - Cleburne, Texas, United States, 76033
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78414
    - GSK Investigational Site
  - Dallas, Texas, United States, 75230
    - GSK Investigational Site
  - Dallas, Texas, United States, 75224
    - GSK Investigational Site
  - Dallas, Texas, United States, 75251
    - GSK Investigational Site
  - Dallas, Texas, United States, 75235
    - GSK Investigational Site
  - Deer Park, Texas, United States, 77536
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76104
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77036
    - GSK Investigational Site
  - Houston, Texas, United States, 77070
    - GSK Investigational Site
  - Houston, Texas, United States, 77074
    - GSK Investigational Site
  - Houston, Texas, United States, 77024
    - GSK Investigational Site
  - Houston, Texas, United States, 77058
    - GSK Investigational Site
  - Houston, Texas, United States, 77055
    - GSK Investigational Site
  - Houston, Texas, United States, 77034
    - GSK Investigational Site
  - Hurst, Texas, United States, 76054
    - GSK Investigational Site
  - Katy, Texas, United States, 77450
    - GSK Investigational Site
  - Lewisville, Texas, United States, 75067
    - GSK Investigational Site
  - Midland, Texas, United States, 79705
    - GSK Investigational Site
  - Odessa, Texas, United States, 79761
    - 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, 78258
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78218
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78224
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229-4801
    - GSK Investigational Site
  - Schertz, Texas, United States, 78154
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77479
    - GSK Investigational Site
  - Sugarland, Texas, United States, 77479
    - GSK Investigational Site
- Utah
  - Salt Lake City, Utah, United States, 84102
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84107
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84120
    - GSK Investigational Site
  - West Jordan, Utah, United States, 84088
    - GSK Investigational Site
  - West Valley City, Utah, United States, 84120
    - 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
  - Norfolk, Virginia, United States, 23502
    - GSK Investigational Site
  - Suffolk, Virginia, United States, 23434
    - GSK Investigational Site
  - Virgina Beach, Virginia, United States, 23455
    - GSK Investigational Site
  - Weber City, Virginia, United States, 24290
    - GSK Investigational Site
- Washington
  - Richland, Washington, United States, 99352
    - GSK Investigational Site
  - Selah, Washington, United States, 98942
    - GSK Investigational Site
  - Spokane, Washington, United States, 99216
    - GSK Investigational Site
- West Virginia
  - Lewisburg, West Virginia, United States, 24901
    - GSK Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

type 2 diabetes
BMI 20-45kg/m2 inclusive

Exclusion Criteria:

females who are pregnant, lactating, or <6 weeks post-partum
CHF NYHA class III-IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: albiglutide albiglutide weekly injection	Biological: albiglutide albiglutide weekly injection
Placebo Comparator: placebo albiglutide matching placebo	Biological: placebo matching albiglutide placebo weekly injection
Experimental: albiglutide up-titration albiglutide weekly injection uptitration at week 12	Biological: albiglutide uptitration albiglutide uptitration at week 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 Time Frame: Baseline and Week 52	Glycated hemoglobin (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 BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. 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 post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.	Baseline and Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hyperglycemia Rescue Time Frame: From the start of study medication until the end of the treatment (up to Week 156)	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. 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 1 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 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.	From the start of study medication until the end of the treatment (up to Week 156)
Change From Baseline in HbA1c at Weeks 104 and 156 Time Frame: Baseline and Weeks 104 and 156	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. 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. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Weeks 104 and 156
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 Time Frame: Baseline and Week 52	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. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 Time Frame: Baseline and Week 156	The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.	Baseline and Week 156
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 Time Frame: Week 52	The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.	Week 52
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 Time Frame: Week 156	The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.	Week 156
Change From Baseline in Body Weight at Week 52 Time Frame: Baseline and Week 52	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52
Change From Baseline in Body Weight at Week 156 Time Frame: Baseline and Week 156	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.	Baseline and Week 156
Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC Time Frame: Baseline and Week 52	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52
Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC Time Frame: Baseline and Week 52	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52
Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC Time Frame: Baseline and Week 52	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52
Albiglutide Plasma Concentration at Weeks 8 and 24 Time Frame: Weeks 8 and 24	Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.	Weeks 8 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

112756

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

Individual Participant Data Set
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 112756

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

University of North Carolina, Chapel Hill
American Heart Association

Recruiting

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine (ALIGN)

Type 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes Education

United States
ENBIOSIS BIOTECHNOLOGIES
Aydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... and other collaborators

Not yet recruiting

AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes (AIM-MET)

Type 2 Diabetes | Diabetes Mellitus Type 2

Turkey (Türkiye)
Instituto Nacional de Ciencias Medicas y Nutricion...

Active, not recruiting

Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus (Apple vinegar)

Type 2 Diabetes Mellitus 2

Mexico
Endogenex, Inc.

Not yet recruiting

Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study

Diabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
University of Salamanca
University of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...

Enrolling by invitation

NMES, Exercise, and Glycemic Control in Older Adults With Type 2 Diabetes (NMES4GlyCon)

Type 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes Mellitus

Portugal
Endogenex, Inc.

Not yet recruiting

Post-market SUrveiLlance RegiStry for the Endogenex System (Endogenex PULSE Registry)

Diabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
University of Colorado, Denver
Massachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaborators

Recruiting

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery (PREPARE 4 AID)

Diabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type II

United States
Kaiser Permanente
The Permanente Medical Group

Enrolling by invitation

Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)

United States
Sanofi

Completed

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI1)

Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Hungary, Russian Federation, Germany, Poland, Japan, United States, Finland
Steno Diabetes Center Copenhagen

Recruiting

Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)

Diabetes | Cognitive Impairment | Type 2 Diabetes | Diabetes Mellitus Type 2 | Cognitive Decline | Type 2 Diabetes Mellitus (T2DM)

Denmark

Clinical Trials on albiglutide

GlaxoSmithKline

Completed

Dose Ranging Study of Albiglutide in Japanese Subjects

Diabetes Mellitus, Type 2

Japan
GlaxoSmithKline
Duke Clinical Research Institute

Completed

Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus

United States, Argentina, Germany, Poland, Russian Federation, Spain, Taiwan, Czechia, Hungary, Italy, Ukraine, Belgium, Netherlands, South Africa, Sweden, Thailand, Korea, Republic of, Mexico, Bulgaria, Hong Kong, Peru, Philippines, Gree... and more
GlaxoSmithKline

Completed

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

Diabetes Mellitus, Type 2

United States
GlaxoSmithKline
PPD

Withdrawn

Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2
GlaxoSmithKline

Completed

A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Diabetes Mellitus, Type 2

Japan
GlaxoSmithKline

Completed

A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.

Diabetes Mellitus, Type 2

United States, South Africa
GlaxoSmithKline

Completed

Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects

Diabetes Mellitus, Type 2

United States
GlaxoSmithKline

Withdrawn

A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2

United States
GlaxoSmithKline

Completed

Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2

United States
GlaxoSmithKline
The General Hospital Corporation d/b/a Massachusetts General Hospital

Terminated

A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects

Diabetes Mellitus

United States

Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on albiglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations