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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098539
First received: April 1, 2010
Last updated: May 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide
Drug: sitagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline; Week 26 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF [ Time Frame: Baseline; Weeks 4, 8, 12, 16, and 20 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline; Week 26 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, and 26 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 [ Time Frame: Week 2 to Week 52 ] [ Designated as safety issue: No ]
    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.

  • Time to Hyperglycemic Rescue Through Week 52 [ Time Frame: Week 2 to Week 52 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Body Weight at Week 26: LOCF [ Time Frame: Baseline; Week 26 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Body Weight Through Week 26: LOCF [ Time Frame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Body Weight Through Week 52: OC [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 507
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Biological: albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Active Comparator: sitagliptin
albiglutide matching placebo + sitagliptin
Drug: sitagliptin
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </=45 kg/m2
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098539

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Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
GSK Investigational Site
Gulf Shores, Alabama, United States, 36542
GSK Investigational Site
Huntsville, Alabama, United States, 35801
GSK Investigational Site
Toney, Alabama, United States, 35773
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85028
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Huntington Beach, California, United States, 92648
GSK Investigational Site
Los Angeles, California, United States, 90022
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Los Angeles, California, United States, 90073
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Los Angeles, California, United States, 90017
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Los Gatos, California, United States, 95032
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Orange, California, United States, 92868
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Diego, California, United States, 92161
GSK Investigational Site
San Dimas, California, United States, 91773
GSK Investigational Site
Tarzana, California, United States, 91356
GSK Investigational Site
West Hills, California, United States, 91307
GSK Investigational Site
Whittier, California, United States, 90603
GSK Investigational Site
Whittier, California, United States, 90602
United States, Florida
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Doral, Florida, United States, 33172
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32205
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Miami, Florida, United States, 33136
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Miami Beach, Florida, United States, 33141
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New Port Richey, Florida, United States, 34653
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Pembroke Pines, Florida, United States, 33028
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Plantation, Florida, United States, 33322
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Tampa, Florida, United States, 33613
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Winter Park, Florida, United States, 32789
GSK Investigational Site
Winter Park, Florida, United States, 32792
United States, Georgia
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Atlanta, Georgia, United States, 30312
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Atlanta, Georgia, United States, 30342
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Augusta, Georgia, United States, 30909
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Blue Ridge, Georgia, United States, 30513
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Decatur, Georgia, United States, 30032
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Roswell, Georgia, United States, 30076
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Stone Mountain, Georgia, United States, 30088
United States, Indiana
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Valparaiso, Indiana, United States, 46383
United States, Iowa
GSK Investigational Site
Des Moines, Iowa, United States, 50314
United States, Kansas
GSK Investigational Site
Mission, Kansas, United States, 66202
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40504
GSK Investigational Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
United States, Maine
GSK Investigational Site
Bangor, Maine, United States, 04401
United States, Maryland
GSK Investigational Site
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Dearborn, Michigan, United States, 48124
GSK Investigational Site
Detroit, Michigan, United States, 48235
GSK Investigational Site
Flint, Michigan, United States, 48504
GSK Investigational Site
St Clair Shores, Michigan, United States, 48081
GSK Investigational Site
Taylor, Michigan, United States, 48180
United States, Missouri
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Kansas City, Missouri, United States, 64128
GSK Investigational Site
Kansas City, Missouri, United States, 64111
GSK Investigational Site
Springfield, Missouri, United States, 65807
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New York
GSK Investigational Site
North Massapequa, New York, United States, 11758
GSK Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Hurst, North Carolina, United States, 76054
GSK Investigational Site
Shelby, North Carolina, United States, 28150
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Cincinnati, Ohio, United States, 45219
GSK Investigational Site
Cleveland, Ohio, United States, 44195
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Gallipolis, Ohio, United States, 45631
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
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Medford, Oregon, United States, 97501
United States, Pennsylvania
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Altoona, Pennsylvania, United States, 16602
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
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Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
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Charleston, South Carolina, United States, 29412
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Columbia, South Carolina, United States, 29204
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Greer, South Carolina, United States, 29651
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North Myrtle Beach, South Carolina, United States, 29582
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Taylors, South Carolina, United States, 29687
United States, Tennessee
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Bristol, Tennessee, United States, 37620
GSK Investigational Site
Franklin, Tennessee, United States, 37067
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Knoxville, Tennessee, United States, 37923
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Tullahoma, Tennessee, United States, 37398
United States, Texas
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Arlington, Texas, United States, 76014
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Arlington, Texas, United States, 76011
GSK Investigational Site
Austin, Texas, United States, 78751
GSK Investigational Site
Austin, Texas, United States, 78758
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Dallas, Texas, United States, 75251
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Dallas, Texas, United States, 75224
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Deer Park, Texas, United States, 77536
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Grapevine, Texas, United States, 76051
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Houston, Texas, United States, 77036
GSK Investigational Site
Houston, Texas, United States, 77099
GSK Investigational Site
Houston, Texas, United States, 77074
GSK Investigational Site
Houston, Texas, United States, 77070
GSK Investigational Site
Houston, Texas, United States, 77027
GSK Investigational Site
Houston, Texas, United States, 77088
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77081
GSK Investigational Site
Humble, Texas, United States, 77338
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Hurst, Texas, United States, 76054
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Irving, Texas, United States, 75039
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Midland, Texas, United States, 79707
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North Richland Hills, Texas, United States, 76180
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Pearland, Texas, United States, 77584
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Plano, Texas, United States, 75075
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Richardson, Texas, United States, 75080
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78217
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San Antonio, Texas, United States, 78215
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Schertz, Texas, United States, 78154
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Sugarland, Texas, United States, 77479
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Tomball, Texas, United States, 77375
United States, Utah
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Bountiful, Utah, United States, 84010
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
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Burke, Virginia, United States, 22015
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Manassas, Virginia, United States, 20110
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Norfolk, Virginia, United States, 23510
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Salem, Virginia, United States, 24153
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
Australia, Australian Capital Territory
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Herston, Queensland, Australia, 4029
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
Clayton, Victoria, Australia, 3168
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Heidelberg, Victoria, Australia, 3081
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Melbourne, Victoria, Australia, 3135
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Parkville, Victoria, Australia, 3050
Australia, Western Australia
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
GSK Investigational Site
Brasília, Brazil, 71625-009
GSK Investigational Site
Mogi das Cruzes, Brazil, 08780 - 090
GSK Investigational Site
São Paulo, Brazil, 05302-001
Colombia
GSK Investigational Site
Barrangquilla, Colombia
GSK Investigational Site
Bogota, Colombia, 110221
GSK Investigational Site
Floridablanca-Santander, Colombia
Germany
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Bad Lauterberg, Niedersachsen, Germany, 37431
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
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Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Berlin, Germany, 10115
India
GSK Investigational Site
Ahmedabad, India, 380015
GSK Investigational Site
Bangalore, India, 560 010
GSK Investigational Site
Bangalore, India, 560052
GSK Investigational Site
Bangalore, India, 560 054
GSK Investigational Site
Bangalore, India, 560078
GSK Investigational Site
Bangalore, India, 560043
GSK Investigational Site
Belgaum, India, 590001
GSK Investigational Site
Belgaum,, India, 590010
GSK Investigational Site
Chennai, India, 600013
GSK Investigational Site
Lucknow, India, 226005
GSK Investigational Site
Manipal, India, 576104
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Mumbai, India, 400 008
GSK Investigational Site
Nasik, India, 422013
Israel
GSK Investigational Site
Ashkelon, Israel, 78278
GSK Investigational Site
Beer-Sheva, Israel, 84101
GSK Investigational Site
Haifa, Israel, 35251
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Holon, Israel, 58100
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Safed, Israel, 13110
Korea, Republic of
GSK Investigational Site
Seongnam-si, Korea, Republic of, 463712
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 139-872
GSK Investigational Site
Seoul, Korea, Republic of, 136-705
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Peru
GSK Investigational Site
Callao, Lima, Peru, Callao 2
GSK Investigational Site
Arequipa, Peru, 54
GSK Investigational Site
Ica, Peru, 11
GSK Investigational Site
Lima, Peru, 01
GSK Investigational Site
Lima, Peru, 17
GSK Investigational Site
Lima, Peru, Lima 1
GSK Investigational Site
Piura, Peru
GSK Investigational Site
Trujillo, Peru
Philippines
GSK Investigational Site
Cebu City, Philippines, 6000
GSK Investigational Site
Iloilo City, Philippines, 5000
GSK Investigational Site
Makati City, Philippines, 1218
GSK Investigational Site
Pasay, Philippines, 1300
GSK Investigational Site
Tagbilaran City, Philippines, 6300
Russian Federation
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603126
GSK Investigational Site
Saratov, Russian Federation, 410030
GSK Investigational Site
St'Petersburg, Russian Federation, 194156
GSK Investigational Site
Yaroslavl, Russian Federation, 150062
South Africa
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2013
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2193
GSK Investigational Site
Lenasia, Gauteng, South Africa, 1827
GSK Investigational Site
Pretoria, Gauteng, South Africa, 0084
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4092
GSK Investigational Site
Phoenix, KwaZulu- Natal, South Africa, 4068
GSK Investigational Site
Houghton, South Africa, 2198
GSK Investigational Site
Pretoria, South Africa, 0002
GSK Investigational Site
Somerset West, South Africa, 07129
GSK Investigational Site
Tygerberg, South Africa, 7505
Spain
GSK Investigational Site
Alicante, Spain, 03114
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Málaga, Spain, 29010
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41003
GSK Investigational Site
Torrevieja (Alicante), Spain, 03186
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 833
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Tainan, Taiwan, 71044
United Kingdom
GSK Investigational Site
Coventry, West Midlands, United Kingdom, CV2 2DX
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
GSK Investigational Site
Hertfordshire, United Kingdom
GSK Investigational Site
Hull, United Kingdom, HU3 2RW
GSK Investigational Site
Liverpool, United Kingdom, L9 7AL
GSK Investigational Site
Livingston, United Kingdom, EH54 6PP
GSK Investigational Site
London, United Kingdom, SE1 9NH
GSK Investigational Site
Plymouth, United Kingdom, PL6 8BX
GSK Investigational Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098539     History of Changes
Other Study ID Numbers: 114130
Study First Received: April 1, 2010
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
sitagliptin
albiglutide
renal impairment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014