AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00849017

Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

A Phase 3 study testing albiglutide and albiglutide uptitration in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 262 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with 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 and albiglutide uptitration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
309 participants
Where
262 sitesin 3 countries
Study dates
Jan 2009to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • CHF NYHA class III-IV

Trial locations and contacts

262 sites in 3 countries.

262 sites in 3 countries

United States247 sites

  • GSK Investigational Site

    Akron, Ohio, 44320

  • GSK Investigational Site

    Alabaster, Alabama, 35007

  • GSK Investigational Site

    Arkansas City, Kansas, 67005

  • GSK Investigational Site

    Arlington, Texas, 76012

  • GSK Investigational Site

    Arvada, Colorado, 80005

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Ashland, Oregon, 97520

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Atlanta, Georgia, 30312

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Baltimore, Maryland, 21237-3998

  • GSK Investigational Site

    Bay City, Michigan, 48708

  • GSK Investigational Site

    Bensalem, Pennsylvania, 19020

  • GSK Investigational Site

    Benzonia, Michigan, 49616

  • GSK Investigational Site

    Berlin, New Jersey, 08009

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35242

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Broken Bow, Nebraska, 68822

  • GSK Investigational Site

    Bull Shoals, Arkansas, 72619

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Burlington, North Carolina, 27215

  • GSK Investigational Site

    Calabash, North Carolina, 28467

  • GSK Investigational Site

    Canal Fulton, Ohio, 44614

  • GSK Investigational Site

    Carmichael, California, 95608

  • GSK Investigational Site

    Chadbourn, North Carolina, 28431

  • GSK Investigational Site

    Chandler, Arizona, 85225

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chicago, Illinois, 60607

  • GSK Investigational Site

    Chula Vista, California, 91910

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • 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, 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

    Crossville, Tennessee, 38555

  • 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

    Dallas, Texas, 75251

  • 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

    Dothan, Alabama, 36301

  • GSK Investigational Site

    Downington, Pennsylvania, 19335

  • GSK Investigational Site

    Dubuque, Iowa, 52001

  • 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

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Evergreen Park, Illinois, 60805

  • GSK Investigational Site

    Fayetteville, North Carolina, 28304

  • GSK Investigational Site

    Foothill Ranch, California, 92610

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gilbert, Arizona, 85295

  • GSK Investigational Site

    Great Falls, Montana, 59405

  • GSK Investigational Site

    Green Valley, Arizona, 85614

  • GSK Investigational Site

    Greensboro, North Carolina, 27455

  • GSK Investigational Site

    Greenville, South Carolina, 29601

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Haddon Heights, New Jersey, 08035

  • GSK Investigational Site

    Hainesport, New Jersey, 08036

  • GSK Investigational Site

    Hallandale, Florida, 33009

  • GSK Investigational Site

    Harrisburg, Pennsylvania, 17112

  • GSK Investigational Site

    Haverhill, Massachusetts, 01830

  • GSK Investigational Site

    Hialeah, Florida, 33012

  • 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, 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, 77070

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Huntington Beach, California, 92646

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Hurst, Texas, 76054

  • 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

    Irvine, California, 92618

  • 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, 64111

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    La Grange, Illinois, 60525

  • GSK Investigational Site

    La Porte, Indiana, 46350

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lakewood, California, 90712

  • GSK Investigational Site

    Lansdale, Pennsylvania, 19446

  • 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, 40504

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • 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

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • 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

    Melrose Park, Pennsylvania, 19027

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Middletown, Delaware, 19709

  • GSK Investigational Site

    Midland, Texas, 79705

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Mint Hill, North Carolina, 28227

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Morehead City, North Carolina, 28557

  • 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

    Newton, Kansas, 67114

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    North Myrtle Beach, South Carolina, 29582

  • 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

    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, 85051

  • GSK Investigational Site

    Picayune, Mississippi, 39466

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Richland, Washington, 99352

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rolling Fork, Mississippi, 39159

  • 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, 84120

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78218

  • GSK Investigational Site

    San Antonio, Texas, 78224

  • GSK Investigational Site

    San Antonio, Texas, 78229-4801

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    San Diego, California, 92177

  • GSK Investigational Site

    Santa Ana, California, 92701

  • GSK Investigational Site

    Satna Monica, California, 90404

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    Savannah, Georgia, 31419

  • 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, 99216

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stratford, New Jersey, 08084

  • GSK Investigational Site

    Suffolk, Virginia, 23434

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Sugarland, Texas, 77479

  • GSK Investigational Site

    Tabor City, North Carolina, 28463

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Taylors, South Carolina, 29687

  • GSK Investigational Site

    Thornville, Ohio, 43076

  • GSK Investigational Site

    Tipton, Pennsylvania, 16684

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Torrance, California, 90503

  • GSK Investigational Site

    Tucker, Georgia, 30084

  • GSK Investigational Site

    Tucson, Arizona, 85745

  • GSK Investigational Site

    Tullahoma, Tennessee, 37388

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Victorville, California, 92395

  • GSK Investigational Site

    Virgina Beach, Virginia, 23455

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Waterloo, Iowa, 50701

  • GSK Investigational Site

    Weber City, Virginia, 24290

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    West Plains, Missouri, 65775

  • GSK Investigational Site

    West Valley City, Utah, 84120

  • GSK Investigational Site

    Zanesville, Ohio, 43701

Other trials in United States

Mexico14 sites

  • GSK Investigational Site

    Cuernavaca, 62250

  • GSK Investigational Site

    Distrito Federal, 06700

  • 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, 27000

  • GSK Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

South Africa1 site

  • GSK Investigational Site

    Parow, 7505

Other trials in South Africa

About this study

Official title: 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.

Being tested
albiglutide, albiglutide uptitration, placebo
Keywords
placebo, albiglutide, monotherapy, 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 weekly injection

  • albiglutide uptitrationBiological

    albiglutide uptitration at week 12

  • placeboBiological

    matching albiglutide placebo weekly injection

Study groups in NCT00849017
Study groupRoleWhat they receive
albiglutideExperimentalalbiglutide weekly injection
Receives: Biological: albiglutide
placeboPlacebo comparatoralbiglutide matching placebo
Receives: Biological: placebo
albiglutide up-titrationExperimentalalbiglutide weekly injection uptitration at week 12
Receives: Biological: albiglutide uptitration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at 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.

    Measured: Baseline and Week 52

Secondary outcomes (12)

  1. Change From Baseline in HbA1c at 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.

    Measured: Baseline and Weeks 104 and 156

  2. Time to Hyperglycemia Rescue

    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.

    Measured: From the start of study medication until the end of the treatment (up to Week 156)

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

    Measured: Baseline and Week 52

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

    Measured: Baseline and Week 156

  5. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at 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.

    Measured: Week 52

  6. 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 acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.

    Measured: Week 156

  7. Change From Baseline in Body Weight at 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.

    Measured: Baseline and Week 52

  8. 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.

    Measured: Baseline and Week 156

  9. Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC

    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.

    Measured: Baseline and Week 52

  10. Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC

    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.

    Measured: Baseline and Week 52

  11. Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC

    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.

    Measured: Baseline and Week 52

  12. Albiglutide Plasma Concentration at 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.

    Measured: Weeks 8 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2011
  4. Study completionFeb 2013

Resources

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
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849017
Sponsor's protocol ID
112756
Status last verified
Nov 2016
First submitted
19 Feb 2009
Last updated
9 Jan 2017
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

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albiglutide and albiglutide uptitration in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 262 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, Mexico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849017, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.

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