A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
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
1 other identifier
interventional
507
15 countries
218
Brief 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 and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started May 2010
Longer than P75 for phase_3 diabetes-mellitus-type-2
218 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2014
CompletedFebruary 28, 2017
January 1, 2017
2.5 years
April 1, 2010
April 17, 2014
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline; Week 26
Secondary Outcomes (15)
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Baseline; Weeks 4, 8, 12, 16, and 20
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Baseline; Week 26
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Baseline; Weeks 4, 8, 12, 16, 20, and 26
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
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
- +10 more secondary outcomes
Study Arms (2)
albiglutide
ACTIVE COMPARATORalbiglutide weekly subcutaneous injection + sitagliptin matching placebo
sitagliptin
ACTIVE COMPARATORalbiglutide matching placebo + sitagliptin
Interventions
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (218)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Gulf Shores, Alabama, 36542, United States
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Toney, Alabama, 35773, United States
GSK Investigational Site
Phoenix, Arizona, 85028, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Los Angeles, California, 90017, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Los Gatos, California, 95032, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92161, United States
GSK Investigational Site
San Dimas, California, 91773, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Whittier, California, 90602, United States
GSK Investigational Site
Whittier, California, 90603, United States
GSK Investigational Site
Doral, Florida, 33172, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami Beach, Florida, 33141, United States
GSK Investigational Site
New Port Richey, Florida, 34653, United States
GSK Investigational Site
Pembroke Pines, Florida, 33028, United States
GSK Investigational Site
Plantation, Florida, 33322, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Winter Park, Florida, 32792, United States
GSK Investigational Site
Atlanta, Georgia, 30312, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30909, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Decatur, Georgia, 30032, United States
GSK Investigational Site
Roswell, Georgia, 30076, United States
GSK Investigational Site
Stone Mountain, Georgia, 30088, United States
GSK Investigational Site
Valparaiso, Indiana, 46383, United States
GSK Investigational Site
Des Moines, Iowa, 50314, United States
GSK Investigational Site
Mission, Kansas, 66202, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Alexandria, Louisiana, 71301, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Hyattsville, Maryland, 20782, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Dearborn, Michigan, 48124, United States
GSK Investigational Site
Detroit, Michigan, 48235, United States
GSK Investigational Site
Flint, Michigan, 48504, United States
GSK Investigational Site
Saint Clair Shores, Michigan, 48081, United States
GSK Investigational Site
Taylor, Michigan, 48180, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
Kansas City, Missouri, 64128, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
North Massapequa, New York, 11758, United States
GSK Investigational Site
Staten Island, New York, 10301, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Hurst, North Carolina, 76054, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Tabor City, North Carolina, 28463, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Gallipolis, Ohio, 45631, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Medford, Oregon, 97501, United States
GSK Investigational Site
Altoona, Pennsylvania, 16602, United States
GSK Investigational Site
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19146, United States
GSK Investigational Site
Charleston, South Carolina, 29412, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
North Myrtle Beach, South Carolina, 29582, United States
GSK Investigational Site
Taylors, South Carolina, 29687, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Franklin, Tennessee, 37067, United States
GSK Investigational Site
Knoxville, Tennessee, 37923, United States
GSK Investigational Site
Tullahoma, Tennessee, 37398, United States
GSK Investigational Site
Arlington, Texas, 76011, United States
GSK Investigational Site
Arlington, Texas, 76014, United States
GSK Investigational Site
Austin, Texas, 78751, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
Dallas, Texas, 75224, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75251, United States
GSK Investigational Site
Deer Park, Texas, 77536, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Grapevine, Texas, 76051, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77036, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Houston, Texas, 77081, United States
GSK Investigational Site
Houston, Texas, 77088, United States
GSK Investigational Site
Houston, Texas, 77099, United States
GSK Investigational Site
Humble, Texas, 77338, United States
GSK Investigational Site
Hurst, Texas, 76054, United States
GSK Investigational Site
Irving, Texas, 75039, United States
GSK Investigational Site
Midland, Texas, 79707, United States
GSK Investigational Site
North Richland Hills, Texas, 76180, United States
GSK Investigational Site
Pearland, Texas, 77584, United States
GSK Investigational Site
Plano, Texas, 75075, United States
GSK Investigational Site
Richardson, Texas, 75080, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78217, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Schertz, Texas, 78154, United States
GSK Investigational Site
Sugarland, Texas, 77479, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
Auchenflower, Queensland, 4066, Australia
GSK Investigational Site
Caboolture, Queensland, 4510, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Heidelberg, Victoria, 3081, Australia
GSK Investigational Site
Melbourne, Victoria, 3135, Australia
GSK Investigational Site
Parkville, Victoria, 3050, Australia
GSK Investigational Site
Fremantle, Western Australia, 6160, Australia
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170, Brazil
GSK Investigational Site
São Paulo, São Paulo, 05302-001, Brazil
GSK Investigational Site
Brasília, 71625-009, Brazil
GSK Investigational Site
Mogi das Cruzes, 08780 - 090, Brazil
GSK Investigational Site
Barrangquilla, Colombia
GSK Investigational Site
Bogotá, 110221, Colombia
GSK Investigational Site
Floridablanca-Santander, Colombia
GSK Investigational Site
Bad Nauheim, Hesse, 61231, Germany
GSK Investigational Site
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Berlin, State of Berlin, 10115, Germany
GSK Investigational Site
Ahmedabad, 380015, India
GSK Investigational Site
Bangalore, 560 010, India
GSK Investigational Site
Bangalore, 560 054, India
GSK Investigational Site
Bangalore, 560043, India
GSK Investigational Site
Bangalore, 560052, India
GSK Investigational Site
Bangalore, 560078, India
GSK Investigational Site
Belagavi, 590001, India
GSK Investigational Site
Belagavi, 590010, India
GSK Investigational Site
Chennai, 600013, India
GSK Investigational Site
Lucknow, 226005, India
GSK Investigational Site
Manipal, 576104, India
GSK Investigational Site
Mumbai, 400 008, India
GSK Investigational Site
Nashik, 422013, India
GSK Investigational Site
Ashkelon, 78278, Israel
GSK Investigational Site
Beersheba, 84101, Israel
GSK Investigational Site
Haifa, 31096, Israel
GSK Investigational Site
Haifa, 35251, Israel
GSK Investigational Site
Holon, 58100, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Safed, 13110, Israel
GSK Investigational Site
Arequipa, Arequipa, 54, Peru
GSK Investigational Site
Ica, Ica, 11, Peru
GSK Investigational Site
Lima, Lima Province, 01, Peru
GSK Investigational Site
Lima, Lima Province, 17, Peru
GSK Investigational Site
Callao, Lima, Callao 2, Peru
GSK Investigational Site
Piura, Piura, Peru
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Trujillo, Peru
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Makati City, 1218, Philippines
GSK Investigational Site
Pasay, 1300, Philippines
GSK Investigational Site
Tagbilaran City, 6300, Philippines
GSK Investigational Site
Nizhny Novgorod, 603126, Russia
GSK Investigational Site
Saratov, 410030, Russia
GSK Investigational Site
St'Petersburg, 194156, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6014, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 2013, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 2193, South Africa
GSK Investigational Site
Lenasia, Gauteng, 1827, South Africa
GSK Investigational Site
Pretoria, Gauteng, 0084, South Africa
GSK Investigational Site
Durban, KwaZulu-Natal, 4092, South Africa
GSK Investigational Site
Phoenix, KwaZulu-Natal, 4068, South Africa
GSK Investigational Site
Houghton Estate, 2198, South Africa
GSK Investigational Site
Pretoria, 0002, South Africa
GSK Investigational Site
Somerset West, 07129, South Africa
GSK Investigational Site
Tygerberg, 7505, South Africa
GSK Investigational Site
Seongnam-si, 463712, South Korea
GSK Investigational Site
Seoul, 135-720, South Korea
GSK Investigational Site
Seoul, 136-705, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 139-872, South Korea
GSK Investigational Site
Suwon, Kyonggi-do, 443-721, South Korea
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Palma de Mallorca, 07014, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41003, Spain
GSK Investigational Site
Torrevieja (Alicante), 03186, Spain
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Tainan, 71044, Taiwan
GSK Investigational Site
Coventry, West Midlands, CV2 2DX, United Kingdom
GSK Investigational Site
Birmingham, B9 5SS, United Kingdom
GSK Investigational Site
Hertfordshire, United Kingdom
GSK Investigational Site
Hull, HU3 2RW, United Kingdom
GSK Investigational Site
Liverpool, L9 7AL, United Kingdom
GSK Investigational Site
Livingston, EH54 6PP, United Kingdom
GSK Investigational Site
London, SE1 9NH, United Kingdom
GSK Investigational Site
Plymouth, PL6 8BX, United Kingdom
GSK Investigational Site
Swansea, SA6 6NL, United Kingdom
Related Publications (2)
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.
PMID: 39963952DERIVEDYoung 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.
PMID: 25387217DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 28, 2017
Results First Posted
May 16, 2014
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.