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Diabetes Mellitus, Type 2Phase 3NCT01098539

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

A Phase 3 study testing albiglutide and sitagliptin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 218 sites in 15 countries.

Completed

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

Official record
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Trial summary

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet… 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 sitagliptin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
507 participants
Where
218 sitesin 15 countries
Study dates
May 2010to Nov 2012
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

  • Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
  • BMI >/=20 kg/m2 and </=45 kg/m2
  • Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
  • HbA1c between 7.0% and 10.0%, inclusive.

Who cannot join

  • History of cancer
  • History of treated diabetic gastroparesis
  • Current biliary disease or history of pancreatitis
  • History of significant gastrointestinal surgery
  • Recent clinically significant cardiovascular and/or cerebrovascular disease
  • History of human immunodeficiency virus infection
Show all 10Show fewer
  • Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
  • Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
  • Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
  • Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies

Trial locations and contacts

218 sites in 15 countries.

218 sites in 15 countries

United States121 sites

  • GSK Investigational Site

    Alexandria, Louisiana, 71301

  • GSK Investigational Site

    Altoona, Pennsylvania, 16602

  • GSK Investigational Site

    Arlington, Texas, 76011

  • GSK Investigational Site

    Arlington, Texas, 76014

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30312

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30909

  • GSK Investigational Site

    Austin, Texas, 78751

  • GSK Investigational Site

    Austin, Texas, 78758

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Bountiful, Utah, 84010

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Charleston, South Carolina, 29412

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Columbia, South Carolina, 29204

  • GSK Investigational Site

    Dallas, Texas, 75224

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75251

  • GSK Investigational Site

    Dearborn, Michigan, 48124

  • GSK Investigational Site

    Decatur, Georgia, 30032

  • GSK Investigational Site

    Deer Park, Texas, 77536

  • GSK Investigational Site

    Des Moines, Iowa, 50314

  • GSK Investigational Site

    Detroit, Michigan, 48235

  • GSK Investigational Site

    Doral, Florida, 33172

  • GSK Investigational Site

    Downington, Pennsylvania, 19335

  • GSK Investigational Site

    Flint, Michigan, 48504

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Franklin, Tennessee, 37067

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gallipolis, Ohio, 45631

  • GSK Investigational Site

    Grapevine, Texas, 76051

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Gulf Shores, Alabama, 36542

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77036

  • GSK Investigational Site

    Houston, Texas, 77070

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Houston, Texas, 77081

  • GSK Investigational Site

    Houston, Texas, 77088

  • GSK Investigational Site

    Houston, Texas, 77099

  • GSK Investigational Site

    Humble, Texas, 77338

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Hurst, North Carolina, 76054

  • GSK Investigational Site

    Hurst, Texas, 76054

  • GSK Investigational Site

    Hyattsville, Maryland, 20782

  • GSK Investigational Site

    Irving, Texas, 75039

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Kansas City, Missouri, 64128

  • GSK Investigational Site

    Knoxville, Tennessee, 37923

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Lexington, Kentucky, 40504

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Los Angeles, California, 90022

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Los Gatos, California, 95032

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Medford, Oregon, 97501

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami Beach, Florida, 33141

  • GSK Investigational Site

    Midland, Texas, 79707

  • GSK Investigational Site

    Mission, Kansas, 66202

  • GSK Investigational Site

    New Port Richey, Florida, 34653

  • GSK Investigational Site

    Norfolk, Virginia, 23510

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    North Myrtle Beach, South Carolina, 29582

  • GSK Investigational Site

    North Richland Hills, Texas, 76180

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Paducah, Kentucky, 42003

  • GSK Investigational Site

    Pearland, Texas, 77584

  • GSK Investigational Site

    Pembroke Pines, Florida, 33028

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19146

  • GSK Investigational Site

    Phoenix, Arizona, 85028

  • GSK Investigational Site

    Plano, Texas, 75075

  • GSK Investigational Site

    Plantation, Florida, 33322

  • GSK Investigational Site

    Richardson, Texas, 75080

  • GSK Investigational Site

    Roswell, Georgia, 30076

  • GSK Investigational Site

    Saint Clair Shores, Michigan, 48081

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    San Dimas, California, 91773

  • GSK Investigational Site

    Schertz, Texas, 78154

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Springfield, Massachusetts, 01107

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    Staten Island, New York, 10301

  • GSK Investigational Site

    Stone Mountain, Georgia, 30088

  • GSK Investigational Site

    Sugarland, Texas, 77479

  • GSK Investigational Site

    Tabor City, North Carolina, 28463

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Taylor, Michigan, 48180

  • GSK Investigational Site

    Taylors, South Carolina, 29687

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Toney, Alabama, 35773

  • GSK Investigational Site

    Tullahoma, Tennessee, 37398

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    Whittier, California, 90602

  • GSK Investigational Site

    Whittier, California, 90603

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winter Park, Florida, 32789

  • GSK Investigational Site

    Winter Park, Florida, 32792

Other trials in United States

India13 sites

  • GSK Investigational Site

    Ahmedabad, 380015

  • GSK Investigational Site

    Bangalore, 560 010

  • GSK Investigational Site

    Bangalore, 560 054

  • GSK Investigational Site

    Bangalore, 560043

  • GSK Investigational Site

    Bangalore, 560052

  • GSK Investigational Site

    Bangalore, 560078

  • GSK Investigational Site

    Belagavi, 590001

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Chennai, 600013

  • GSK Investigational Site

    Lucknow, 226005

  • GSK Investigational Site

    Manipal, 576104

  • GSK Investigational Site

    Mumbai, 400 008

  • GSK Investigational Site

    Nashik, 422013

Other trials in India

Australia12 sites

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Caboolture, Queensland, 4510

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Heidelberg, Victoria, 3081

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Melbourne, Victoria, 3135

  • GSK Investigational Site

    Parkville, Victoria, 3050

Other trials in Australia

South Africa11 sites

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4092

  • GSK Investigational Site

    Houghton Estate, 2198

  • GSK Investigational Site

    Johannesburg, Gauteng, 2013

  • GSK Investigational Site

    Johannesburg, Gauteng, 2193

  • GSK Investigational Site

    Lenasia, Gauteng, 1827

  • GSK Investigational Site

    Phoenix, KwaZulu-Natal, 4068

  • GSK Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • GSK Investigational Site

    Pretoria, Gauteng, 0084

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Somerset West, 07129

  • GSK Investigational Site

    Tygerberg, 7505

Other trials in South Africa

United Kingdom9 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Coventry, West Midlands, CV2 2DX

  • GSK Investigational Site

    Hertfordshire

  • GSK Investigational Site

    Hull, HU3 2RW

  • GSK Investigational Site

    Liverpool, L9 7AL

  • GSK Investigational Site

    Livingston, EH54 6PP

  • GSK Investigational Site

    London, SE1 9NH

  • GSK Investigational Site

    Plymouth, PL6 8BX

  • GSK Investigational Site

    Swansea, SA6 6NL

Other trials in United Kingdom

Peru8 sites

  • GSK Investigational Site

    Arequipa, Arequipa, 54

  • 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, 17

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Piura, Piura

  • GSK Investigational Site

    Trujillo

Other trials in Peru

Israel7 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Haifa, 35251

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Safed, 13110

Other trials in Israel

Spain7 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41003

  • GSK Investigational Site

    Torrevieja (Alicante), 03186

Other trials in Spain

South Korea6 sites

  • GSK Investigational Site

    Seongnam-si, 463712

  • GSK Investigational Site

    Seoul, 135-720

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 139-872

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Germany5 sites

  • GSK Investigational Site

    Bad Lauterberg im Harz, Lower Saxony, 37431

  • GSK Investigational Site

    Bad Nauheim, Hesse, 61231

  • GSK Investigational Site

    Berlin, State of Berlin, 10115

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

Other trials in Germany

Philippines5 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Makati City, 1218

  • GSK Investigational Site

    Pasay, 1300

  • GSK Investigational Site

    Tagbilaran City, 6300

Other trials in Philippines

Brazil4 sites

  • GSK Investigational Site

    Brasília, 71625-009

  • GSK Investigational Site

    Mogi das Cruzes, 08780 - 090

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • GSK Investigational Site

    São Paulo, São Paulo, 05302-001

Other trials in Brazil

Russia4 sites

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Saratov, 410030

  • GSK Investigational Site

    St'Petersburg, 194156

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Colombia3 sites

  • GSK Investigational Site

    Barrangquilla

  • GSK Investigational Site

    Bogotá, 110221

  • GSK Investigational Site

    Floridablanca-Santander

Other trials in Colombia

Taiwan3 sites

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Tainan, 71044

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Read the detailed description

This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Being tested
albiglutide, sitagliptin
Keywords
sitagliptin, albiglutide, renal impairment
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • albiglutideBiological

    albiglutide weekly subcutaneous injection + sitagliptin matching placebo

  • sitagliptinDrug

    albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Study groups in NCT01098539
Study groupRoleWhat they receive
albiglutideActive comparatoralbiglutide weekly subcutaneous injection + sitagliptin matching placebo
Receives: Biological: albiglutide
sitagliptinActive comparatoralbiglutide matching placebo + sitagliptin
Receives: Drug: sitagliptin

What is being measured

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

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Baseline; Week 26

Secondary outcomes (15)

  1. Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline; Weeks 4, 8, 12, 16, and 20

  2. Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.

    Measured: Baseline; Week 26

  4. Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF

    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 in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline; Weeks 4, 8, 12, 16, 20, and 26

  5. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52

  6. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF

    The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Week 26

  7. Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF

    The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Week 26

  8. Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC

    The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Week 52

  9. Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC

    The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Week 52

  10. Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52

    Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.

    Measured: Week 2 to Week 52

  11. Time to Hyperglycemic Rescue Through Week 52

    Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.

    Measured: Week 2 to Week 52

  12. Change From Baseline in Body Weight at Week 26: LOCF

    Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.

    Measured: Baseline; Week 26

  13. Change From Baseline in Body Weight Through Week 26: LOCF

    Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.

    Measured: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26

  14. Change From Baseline in Body Weight Through Week 52: OC

    Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

    Measured: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52

  15. Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16

    Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.

    Measured: Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)

Timeline

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

  1. First posted2 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098539
Sponsor's protocol ID
114130
Status last verified
Jan 2017
First submitted
1 Apr 2010
Last updated
28 Feb 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

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

    PubMed 25387217

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albiglutide and sitagliptin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 218 sites in 15 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 4 inclusion and 10 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in United States, India, Australia, South Africa, United Kingdom and 10 more countries. 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. 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 16 May 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 in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline; Week 26). 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 NCT01098539, which also lists 2 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 28 Feb 2017.

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