Last updated: 11/07/2018 07:15:01
A study of the efficacy and safety of albiglutide in subjects with type 2 diabetes with renal impairment.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 26
Timeframe: Baseline; Week 26
Secondary outcomes:
Mean change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Timeframe: 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
Timeframe: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Change from Baseline in fasting plasma glucose (FPG) at Week 26
Timeframe: Baseline; Week 26
Mean change from Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Timeframe: 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
Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
Number of participants who achieved clinically meaningful HbA1c response levels of <6.5% and <7.0% at Week 26: LOCF
Timeframe: Week 26
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
Timeframe: Week 26
Number of participants who achieved a clinically meaningful HbA1c response level of <6.5% and <7.0% at Week 52: OC
Timeframe: Week 52
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
Timeframe: Week 52
Number of participants with the indicated time to hyperglycemic rescue through Week 52
Timeframe: Week 2 to Week 52
Time to hyperglycemic rescue through Week 52
Timeframe: Week 2 to Week 52
Change from Baseline in body weight at Week 26: LOCF
Timeframe: Baseline; Week 26
Change from Baseline in body weight through Week 26: LOCF
Timeframe: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Change from Baseline in body weight through Week 52: OC
Timeframe: 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
Plasma concentrations (conc.) of albiglutide at Week 8 and Week 16
Timeframe: 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)
Interventions:
Biological/vaccine: albiglutide
Drug: sitagliptin
Enrollment:
507
Observational study model:
Not applicable
Primary completion date:
2012-05-11
Time perspective:
Not applicable
Clinical publications:
Malcolm A. Young, PhD, Jeffrey A. Wald, PhD, Jessica E. Matthews, BS, Rickey Reinhardt, MD, PhD .Effect of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Albiglutide.Postgrad Med.2014;126(3):36-46.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
GSK
Study date(s)
May 2010 to November 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- History of cancer
- History of treated diabetic gastroparesis
Inclusion and exclusion criteria
Inclusion criteria:
- 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
- Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
- HbA1c between 7.0% and 10.0%, inclusive.
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Richardson, Texas, United States, 75080
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2013
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92161
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrevieja (Alicante), Spain, 03186
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Myrtle Beach, South Carolina, United States, 29582
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23510
Status
Study Complete
Location
GSK Investigational Site
Livingston, United Kingdom, EH54 6PP
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Victoria, Australia, 3081
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34653
Status
Study Complete
Location
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28150
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85028
Status
Study Complete
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Dimas, California, United States, 91773
Status
Study Complete
Location
GSK Investigational Site
Clayton, Victoria, Australia, 3168
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Gatos, California, United States, 95032
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19146
Status
Study Complete
Location
GSK Investigational Site
Franklin, Tennessee, United States, 37067
Status
Study Complete
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4092
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Study Complete
Location
GSK Investigational Site
West Hills, California, United States, 91307
Status
Study Complete
Location
GSK Investigational Site
Whittier, California, United States, 90603
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48235
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32792
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, KwaZulu- Natal, South Africa, 4068
Status
Study Complete
Location
GSK Investigational Site
Taylors, South Carolina, United States, 29687
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33322
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Hurst, North Carolina, United States, 76054
Status
Study Complete
Location
GSK Investigational Site
Gulf Shores, Alabama, United States, 36542
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tarzana, California, United States, 91356
Status
Study Complete
Location
GSK Investigational Site
Liverpool, United Kingdom, L9 7AL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Study Complete
Location
GSK Investigational Site
St Clair Shores, Michigan, United States, 48081
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Roswell, Georgia, United States, 30076
Status
Study Complete
Location
GSK Investigational Site
North Massapequa, New York, United States, 11758
Status
Study Complete
Location
GSK Investigational Site
Midland, Texas, United States, 79707
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29412
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Taylor, Michigan, United States, 48180
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76011
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Medford, Oregon, United States, 97501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78217
Status
Study Complete
Location
GSK Investigational Site
Coventry, West Midlands, United Kingdom, CV2 2DX
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90017
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tullahoma, Tennessee, United States, 37398
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Status
Study Complete
Location
GSK Investigational Site
Deer Park, Texas, United States, 77536
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hyattsville, Maryland, United States, 20782
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Location
GSK Investigational Site
Dearborn, Michigan, United States, 48124
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30312
Status
Study Complete
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Indiana, United States, 46383
Status
Study Complete
Location
GSK Investigational Site
Swansea, United Kingdom, SA6 6NL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miami Beach, Florida, United States, 33141
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64128
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05302-001
Status
Study Complete
Location
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Status
Study Complete
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
Status
Study Complete
Location
GSK Investigational Site
Santiago de Compostela, Spain, 15706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
Herston, Queensland, Australia, 4029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Study Complete
Location
GSK Investigational Site
Staten Island, New York, United States, 10301
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Lauterberg, Niedersachsen, Germany, 37431
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Arlington, Texas, United States, 76014
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50314
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42003
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37923
Status
Study Complete
Location
GSK Investigational Site
Whittier, California, United States, 90602
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Plymouth, United Kingdom, PL6 8BX
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gallipolis, Ohio, United States, 45631
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33613
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Parkville, Victoria, Australia, 3050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30032
Status
Study Complete
Location
GSK Investigational Site
Stone Mountain, Georgia, United States, 30088
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33028
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grapevine, Texas, United States, 76051
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-05-11
Actual study completion date
2012-05-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website