Diabetes Mellitus, Type 2Phase 3NCT00838903
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
A Phase 3 study testing albiglutide, sitagliptin and glimepiride in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 386 sites in 11 countries.
Trial summary
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- albiglutide, sitagliptin and glimepiride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,049 participants
- Where
- 386 sitesin 11 countries
- Study dates
- Feb 2009to Apr 2013
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Who cannot join
- females who are pregnant, lactating or <6 weeks post-partum
- current symptomatic heart failure (NYHA Class III or IV)
Trial locations and contacts
386 sites in 11 countries.
369 sites in 11 countries
United States300 sites
GSK Investigational Site
Akron, Ohio, 44320
GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Arlington, Texas, 76012
GSK Investigational Site
Arvada, Colorado, 80005
GSK Investigational Site
Asheboro, North Carolina, 27203
GSK Investigational Site
Asheville, North Carolina, 28803
GSK Investigational Site
Ashland, Oregon, 97520
GSK Investigational Site
Atlanta, Georgia, 30135
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30312
GSK Investigational Site
Atlanta, Georgia, 30328
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Aurora, Illinois, 60504
GSK Investigational Site
Baltimore, Maryland, 21237
GSK Investigational Site
Bay City, Michigan, 48706
GSK Investigational Site
Bedford, Texas, 76201
GSK Investigational Site
Bensalem, Pennsylvania, 19020
GSK Investigational Site
Benzonia, Michigan, 49616
GSK Investigational Site
Berlin, New Jersey, 08009
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Birmingham, Alabama, 35242
GSK Investigational Site
Blue Ridge, Georgia, 30513
GSK Investigational Site
Bountiful, Utah, 84010
GSK Investigational Site
Boynton Beach, Florida, 33426
GSK Investigational Site
Boynton Beach, Florida, 33437
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Broken Bow, Nebraska, 68822
GSK Investigational Site
Buena Park, California, 90620
GSK Investigational Site
Bull Shoals, Arkansas, 72619
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Burlington, North Carolina, 27215
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Cadillac, Michigan, 49601
GSK Investigational Site
Calabash, North Carolina, 28467
GSK Investigational Site
Canal Fulton, Ohio, 44614
GSK Investigational Site
Carlisle, Pennsylvania, 17013
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Chadbourn, North Carolina, 28431
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Chattanooga, Tennessee, 37421
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Chino, California, 91710
GSK Investigational Site
Chula Vista, California, 91910
GSK Investigational Site
Cincinnati, Ohio, 45211
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Cincinnati, Ohio, 45227
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Clarksville, Tennessee, 37043
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Clearwater, Florida, 33765
GSK Investigational Site
Cleburne, Texas, 76033
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Cocoa, Florida, 32927
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbia, Tennessee, 38401
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Columbus, Ohio, 43212
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Corpus Christi, Texas, 78414
GSK Investigational Site
Council Bluffs, Iowa, 51501
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Crescent Springs, Kentucky, 41017
GSK Investigational Site
Cumberland, Rhode Island, 02864
GSK Investigational Site
Cutler Bay, Florida, 33189
GSK Investigational Site
Dallas, Texas, 75224
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Dayton, Ohio, 45432
GSK Investigational Site
Dayton, Ohio, 45439
GSK Investigational Site
Dearborn, Michigan, 48124
GSK Investigational Site
Decatur, Georgia, 30032
GSK Investigational Site
Deer Park, Texas, 77536
GSK Investigational Site
Deerfield Beach, Florida, 33442
GSK Investigational Site
Delray Beach, Florida, 33445
GSK Investigational Site
Des Moines, Iowa, 50314
GSK Investigational Site
Dothan, Alabama, 36301
GSK Investigational Site
Downington, Pennsylvania, 19335
GSK Investigational Site
Dubuque, Iowa, 52001
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Elizabeth, New Jersey, 07202
GSK Investigational Site
Escondido, California, 92026
GSK Investigational Site
Evergreen Park, Illinois, 60805
GSK Investigational Site
Fayetteville, North Carolina, 28304
GSK Investigational Site
Fayetteville, Tennessee, 37334
GSK Investigational Site
Feasterville, Pennsylvania, 19053
GSK Investigational Site
Federal Way, Washington, 98003
GSK Investigational Site
Fishers, Indiana, 46037
GSK Investigational Site
Foothill Ranch, California, 92610
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Gainesville, Florida, 32605
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Gilbert, Arizona, 85295
GSK Investigational Site
Grand Forks, North Dakota, 58201
GSK Investigational Site
Great Falls, Montana, 59405
GSK Investigational Site
Green Valley, Arizona, 85614
GSK Investigational Site
Greensboro, North Carolina, 27405
GSK Investigational Site
Greenville, South Carolina, 29601
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Gulfport, Mississippi, 39501
GSK Investigational Site
Haddon Heights, New Jersey, 08035
GSK Investigational Site
Hainesport, New Jersey, 08036
GSK Investigational Site
Hallandale, Florida, 33009
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Harrisburg, Arkansas, 72432
GSK Investigational Site
Harrisburg, Pennsylvania, 17112
GSK Investigational Site
Haverhill, Massachusetts, 01830
GSK Investigational Site
Hialeah, Florida, 33012
GSK Investigational Site
Hialeah, Florida, 33013
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Hollywood, Florida, 33023
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Honolulu, Hawaii, 96814
GSK Investigational Site
Hot Springs, Arkansas, 71913
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77036
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Houston, Texas, 77058
GSK Investigational Site
Houston, Texas, 77069
GSK Investigational Site
Houston, Texas, 77070
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Houston, Texas, 77094
GSK Investigational Site
Hueytown, Alabama, 35023
GSK Investigational Site
Huntersville, North Carolina, 28078
GSK Investigational Site
Huntington Beach, California, 92646
GSK Investigational Site
Hurst, Texas, 76054
GSK Investigational Site
Hyattsville, Maryland, 20782
GSK Investigational Site
Idaho Falls, Idaho, 83404
GSK Investigational Site
Indianapolis, Indiana, 46254
GSK Investigational Site
Indio, California, 92201
GSK Investigational Site
Interlochen, Michigan, 49643
GSK Investigational Site
Iowa City, Iowa, 52243
GSK Investigational Site
Jefferson City, Missouri, 65109
GSK Investigational Site
Johnson City, Tennessee, 37604
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kalamazoo, Michigan, 49048
GSK Investigational Site
Kansas City, Missouri, 64106
GSK Investigational Site
Kansas City, Missouri
GSK Investigational Site
Katy, Texas, 77450
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
La Grange, Illinois, 60525
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
La Porte, Indiana, 46350
GSK Investigational Site
Lake Charles, Louisiana, 70601
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Lakewood, California, 90712
GSK Investigational Site
Landsdale, Pennsylvania, 19446
GSK Investigational Site
Las Vegas, Nevada, 89102-4509
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Las Vegas, Nevada, 89103
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Las Vegas, Nevada, 89128
GSK Investigational Site
Lauderdale Lakes, Florida, 33319
GSK Investigational Site
Lenoir, North Carolina, 28645
GSK Investigational Site
Lewisburg, West Virginia, 24901
GSK Investigational Site
Lewisville, Texas, 75067
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Lexington, Kentucky, 40504
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Loma Linda, California, 92354
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Alamitos, California, 90720
GSK Investigational Site
Los Angeles, California, 90017
GSK Investigational Site
Los Angeles, California, 90022
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
Manassas, Virginia, 20110
GSK Investigational Site
Manning, South Carolina, 29102
GSK Investigational Site
Marianna, Florida, 32446
GSK Investigational Site
Mason, Ohio, 45040
GSK Investigational Site
Maumee, Ohio, 43537-9402
GSK Investigational Site
McKenzie, Tennessee, 38201
GSK Investigational Site
Memphis, Tennessee, 38125
GSK Investigational Site
Miami, Florida, 33135
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Middletown, Delaware, 19709
GSK Investigational Site
Midland, Texas, 79707
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Mint Hill, North Carolina, 28227
GSK Investigational Site
Mission, Kansas, 66202
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mobile, Alabama, 36617
GSK Investigational Site
Morehead City, North Carolina, 28557
GSK Investigational Site
Muncie, Indiana, 47304
GSK Investigational Site
Murrells Inlet, South Carolina, 29576
GSK Investigational Site
Naperville, Illinois, 60564
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New Britain, Connecticut, 06050
GSK Investigational Site
New Brunswick, New Jersey, 08903
GSK Investigational Site
New York, New York, 10022
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
North Massapequa, New York, 11758
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
North Myrtle Beach, South Carolina, 29582
GSK Investigational Site
North Richland Hills, Texas, 76180
GSK Investigational Site
Northridge, California, 91325
GSK Investigational Site
Ocala, Florida, 34471
GSK Investigational Site
Odessa, Texas, 79761
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Omaha, Nebraska, 68124
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Orangeburg, South Carolina, 29115
GSK Investigational Site
Orem, Utah, 84058
GSK Investigational Site
Orlando, Florida, 32822
GSK Investigational Site
Ormond Beach, Florida, 32174
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Oviedo, Florida, 32765
GSK Investigational Site
Oxon Hill, Maryland, 20745
GSK Investigational Site
Paducah, Kentucky, 42003
GSK Investigational Site
Palm Desert, California, 92260
GSK Investigational Site
Panama City, Florida, 32401
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Pembroke Pines, Florida, 33026
GSK Investigational Site
Pembroke Pines, Florida, 33027
GSK Investigational Site
Peoria, Illinois, 61602
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Phoenix, Arizona, 85028
GSK Investigational Site
Phoenix, Arizona, 85051
GSK Investigational Site
Picayune, Mississippi, 39466
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Ponte Vedra Beach, Florida, 32081
GSK Investigational Site
Poway, California, 92064
GSK Investigational Site
Richland, Washington, 99352
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rolling Fork, Mississippi, 39159
GSK Investigational Site
Sacramento, California, 95821
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
Saint Clair Shores, Michigan, 48081
GSK Investigational Site
Saint Cloud, Florida, 34769
GSK Investigational Site
Salt Lake City, Utah, 84102
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
Salt Lake City, Utah, 84124
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78215
GSK Investigational Site
San Antonio, Texas, 78217
GSK Investigational Site
San Antonio, Texas, 78218
GSK Investigational Site
San Antonio, Texas, 78224
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Antonio, Texas, 78237
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
San Diego, California, 92117
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
Santa Ana, California, 92701
GSK Investigational Site
Satna Monica, California, 90404
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Schertz, Texas, 78154
GSK Investigational Site
Searcy, Arkansas, 72143
GSK Investigational Site
Selah, Washington, 98942
GSK Investigational Site
Shelby, North Carolina, 28150
GSK Investigational Site
Shreveport, Louisiana, 71101
GSK Investigational Site
Shreveport, Louisiana, 71115
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Snellville, Georgia, 30078
GSK Investigational Site
South Bend, Indiana, 46614
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Spokane, Washington, 99208
GSK Investigational Site
Spokane, Washington, 99216
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Springfield, Missouri, 65807
GSK Investigational Site
St Louis, Missouri, 63117
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33709
GSK Investigational Site
Stone Mountain, Georgia, 30088
GSK Investigational Site
Stratford, New Jersey, 08084
GSK Investigational Site
Suffolk, Virginia
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Sugarland, Texas, 77479
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Tabor City, North Carolina, 28463
GSK Investigational Site
Tampa, Florida, 33603
GSK Investigational Site
Tarzana, California, 91356
GSK Investigational Site
Taylors, South Carolina, 29687
GSK Investigational Site
Temple, Texas, 76508
GSK Investigational Site
Thornville, Ohio, 43076
GSK Investigational Site
Tipton, Pennsylvania, 16684
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Trumbull, Connecticut, 06611
GSK Investigational Site
Tucker, Georgia, 30084
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Tullahoma, Tennessee, 37398
GSK Investigational Site
Tulsa, Oklahoma, 74104
GSK Investigational Site
Tulsa, Oklahoma, 74135
Mexico16 sites
GSK Investigational Site
Cuernavaca, Morelos, 62250
GSK Investigational Site
Distrito Federal, 06700
GSK Investigational Site
Durango, Durango, 34080
GSK Investigational Site
Guadalajara, Jalisco, 44670
GSK Investigational Site
Guadalajara, 44600
GSK Investigational Site
Guadalajara, 44680
GSK Investigational Site
Mérida, Yucatán, 97000
GSK Investigational Site
Mexico City, 03300
GSK Investigational Site
Mexico City, 11570
GSK Investigational Site
Morelia, Michoacán, C.P. 58249
GSK Investigational Site
Nezahualcóyotl, 57170
GSK Investigational Site
Pachuca, Hidalgo, 42086
GSK Investigational Site
Puebla City, Puebla, 72190
GSK Investigational Site
Tijuana, Baja California Norte, 22010
GSK Investigational Site
Torreón, Coahuila, 27000
GSK Investigational Site
Zapopan, Jalisco, 45200
South Africa12 sites
GSK Investigational Site
Boksburg North, Gauteng, 1459
GSK Investigational Site
Cape Town, 7530
GSK Investigational Site
Durban, KwaZulu-Natal, 4000
GSK Investigational Site
Johannesburg, Gauteng, 01820
GSK Investigational Site
Kempton Park, 1619
GSK Investigational Site
Lenasia, Gauteng, 1827
GSK Investigational Site
Parktown, Gauteng, 2193
GSK Investigational Site
Parow, 7505
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6014
GSK Investigational Site
Pretoria, Gauteng, 00083
GSK Investigational Site
Somerset West, 07129
GSK Investigational Site
Soweto, 1111
United Kingdom11 sites
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD
GSK Investigational Site
Canterbury, Kent, CT1 3HX
GSK Investigational Site
Coventry, West Midlands, CV2 2DX
GSK Investigational Site
Glasgow, G45 9AW
GSK Investigational Site
Hull, HU3 2RW
GSK Investigational Site
Liverpool, Merseyside, L7 8XP
GSK Investigational Site
Liverpool, L9 7AL
GSK Investigational Site
London, SE1 9NH
GSK Investigational Site
Plymouth, Devon, PL6 8BX
GSK Investigational Site
Port Glasgow, Renfrewshire, PA14 6HW
GSK Investigational Site
Sunbury-on-Thames, Middlesex, TW16 6RH
Germany7 sites
GSK Investigational Site
Bad Lauterberg im Harz, Lower Saxony, 37431
GSK Investigational Site
Berlin, State of Berlin, 10115
GSK Investigational Site
Kelkheim, Hesse, 65779
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Rotenburg an der Fulda, Hesse, 36199
GSK Investigational Site
Villingen-Schwenningen, Baden-Wurttemberg, 78054
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455
Russia7 sites
GSK Investigational Site
Arkhangelsk, 163045
GSK Investigational Site
Irkutsk, 664003
GSK Investigational Site
Moscow, 119034
GSK Investigational Site
Nizhny Novgorod, 603126
GSK Investigational Site
Saratov, 410030
GSK Investigational Site
Smolensk, 214019
GSK Investigational Site
Yaroslavl, 150062
Peru5 sites
GSK Investigational Site
Callao, Lima, Callao 2
GSK Investigational Site
Ica, Ica, 11
GSK Investigational Site
Lima, Lima Province, 01
GSK Investigational Site
Lima, Lima Province, Lima 1
GSK Investigational Site
Piura, Piura
Philippines5 sites
GSK Investigational Site
Cebu City, 6000
GSK Investigational Site
Quezon City, 1101
GSK Investigational Site
Quezon City, 1102
GSK Investigational Site
San Juan City, 1500
GSK Investigational Site
Taytay Rizal, 1920
Hong Kong3 sites
GSK Investigational Site
Kwun Tong, Kowloon
GSK Investigational Site
Shatin
GSK Investigational Site
Tai Po
Spain2 sites
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Seville, 41003
About this study
Official title: A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- albiglutide, sitagliptin, glimepiride, metformin, placebo albiglutide
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albiglutideBiological
albiglutide
sitagliptinDrug
sitagliptin
glimepirideDrug
Glimepiride
metforminDrug
Metformin
placebo albiglutideBiological
placebo to match albiglutide
placebo sitagliptinDrug
placebo to match sitagliptin
placebo glimepirideDrug
placebo to match glimepiride
| Study group | Role | What they receive |
|---|---|---|
| albiglutide + metformin | Experimental | Albiglutide + metformin + placebo sitagliptin + placebo glimepiride Receives: Biological: albiglutide; Drug: metformin; Drug: placebo sitagliptin; Drug: placebo glimepiride |
| sitagliptin + metformin | Active comparator | Sitagliptin + metformin + placebo albiglutide + placebo glimepiride Receives: Drug: sitagliptin; Drug: metformin; Biological: placebo albiglutide; Drug: placebo glimepiride |
| glimepiride + metformin | Active comparator | Glimepiride + metformin + placebo albiglutide + placebo sitagliptin Receives: Drug: glimepiride; Drug: metformin; Biological: placebo albiglutide; Drug: placebo sitagliptin |
| metformin + placebo | Active comparator | Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride Receives: Drug: metformin; Biological: placebo albiglutide; Drug: placebo sitagliptin; Drug: placebo glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
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 value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.
Measured: Baseline and Week 104
Secondary outcomes (8)
Change From Baseline in HbA1c at Week 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 .
Measured: Baseline and Week 156
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104
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 FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Measured: Baseline and Week 104
Change From Baseline in FPG at Week 156
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 Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Measured: Baseline and Week 156
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
Measured: Week 104
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.
Measured: Week 156
Time to Hyperglycemia Rescue
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic 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 week
Measured: From the start of study medication until the end of the treatment (up to Week 156)
Change From Baseline in Body Weight at Week 104
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 + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Measured: Baseline and Week 104
Change From Baseline in Body Weight at 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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Measured: Baseline and Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838903
- Sponsor's protocol ID
- 112753
- Status last verified
- Nov 2016
- First submitted
- 5 Feb 2009
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.
PubMed 28683300