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: November 21, 2012
Last verified: August 2012
  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:
  • Evaluation of the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    change from baseline


Secondary Outcome Measures:
  • HbA1c change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    change from baseline over time

  • Fasting plasma glucose (FPG) change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    change from baseline over time

  • Proportion of subjects at a HbA1c treatment goal of <7.0% or <6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    HbA1c responders

  • Time to hyperglycemia rescue [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    measure of time taken to require rescue medication

  • Change from Baseline in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    change from baseline

  • The effect of plasma concentrations of albiglutide on glycemic control (population PK/PD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    population PK/PD


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

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Locations
United States, Alabama
GSK Investigational Site
Gulf Shores, Alabama, United States, 36542
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Huntsville, Alabama, United States, 35801
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Toney, Alabama, United States, 35773
United States, Arizona
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Phoenix, Arizona, United States, 85028
United States, California
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Fresno, California, United States, 93720
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Huntington Beach, California, United States, 92648
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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 Angeles, California, United States, 90022
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Los Gatos, California, United States, 95032
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Orange, California, United States, 92868
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San Diego, California, United States, 92120
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San Diego, California, United States, 92161
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San Dimas, California, United States, 91773
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Tarzana, California, United States, 91356
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West Hills, California, United States, 91307
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Whittier, California, United States, 90603
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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Winter Park, Florida, United States, 32789
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Winter Park, Florida, United States, 32792
United States, Georgia
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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
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Valparaiso, Indiana, United States, 46383
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Des Moines, Iowa, United States, 50314
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Mission, Kansas, United States, 66202
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Lexington, Kentucky, United States, 40504
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Paducah, Kentucky, United States, 42003
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Alexandria, Louisiana, United States, 71301
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Bangor, Maine, United States, 04401
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Hyattsville, Maryland, United States, 20782
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Springfield, Massachusetts, United States, 01107
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Dearborn, Michigan, United States, 48124
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Detroit, Michigan, United States, 48235
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Flint, Michigan, United States, 48504
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St Clair Shores, Michigan, United States, 48081
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Taylor, Michigan, United States, 48180
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Kansas City, Missouri, United States, 64128
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Kansas City, Missouri, United States, 64111
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Springfield, Missouri, United States, 65807
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Omaha, Nebraska, United States, 68131
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Las Vegas, Nevada, United States, 89102
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New York, New York, United States, 10025
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North Massapequa, New York, United States, 11758
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Staten Island, New York, United States, 10301
United States, North Carolina
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Asheville, North Carolina, United States, 28801
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Hurst, North Carolina, United States, 76054
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Shelby, North Carolina, United States, 28150
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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
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44195
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Gallipolis, Ohio, United States, 45631
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Oklahoma City, Oklahoma, United States, 73103
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Medford, Oregon, United States, 97501
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Altoona, Pennsylvania, United States, 16602
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Downington, Pennsylvania, United States, 19335
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Philadelphia, Pennsylvania, United States, 19146
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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
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Bristol, Tennessee, United States, 37620
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Knoxville, Tennessee, United States, 37923
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Arlington, Texas, United States, 76011
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Arlington, Texas, United States, 76014
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Austin, Texas, United States, 78758
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Austin, Texas, United States, 78751
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75224
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Dallas, Texas, United States, 75251
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Deer Park, Texas, United States, 77536
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77036
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Houston, Texas, United States, 77099
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77088
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77027
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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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Tomball, Texas, United States, 77375
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Bountiful, Utah, United States, 84010
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Manassas, Virginia, United States, 20110
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Norfolk, Virginia, United States, 23510
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Tacoma, Washington, United States, 98405
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Herston, Queensland, Australia, 4029
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Kippa Ring, Queensland, Australia, 4021
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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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
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Fremantle, Western Australia, Australia, 6160
Australia
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Garran, ACT, Australia, 2606
Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
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Brasília, Brazil, 71625-009
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Mogi das Cruzes, Brazil, 08780 - 090
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São Paulo, Brazil, 05302-001
Colombia
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Barrangquilla, Colombia
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Bogota, Colombia, 110221
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Floridablanca-Santander, Colombia
Germany
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Bad Nauheim, Hessen, Germany, 61231
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Bad Lauterberg, Niedersachsen, Germany, 37431
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Mainz, Rheinland-Pfalz, Germany, 55116
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Dresden, Sachsen, Germany, 01307
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Berlin, Germany, 10115
India
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Ahmedabad, India, 380015
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Bangalore, India, 560 010
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Bangalore, India, 560 054
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Bangalore, India, 560052
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Bangalore, India, 560043
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Bangalore, India, 560078
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Belgaum, India, 590001
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Belgaum,, India, 590010
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Chennai, India, 600013
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Lucknow, India, 226005
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Nasik, India, 422013
Israel
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Ashkelon, Israel, 78278
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Beer-Sheva, Israel, 84101
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Haifa, Israel, 35251
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Haifa, Israel, 31096
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Holon, Israel, 58100
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Kfar Saba, Israel, 44281
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Nahariya, Israel
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Safed, Israel, 13110
Korea, Republic of
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Seongnam-si, Korea, Republic of, 463712
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Seoul, Korea, Republic of, 139-872
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 137-701
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Suwon, Kyonggi-do, Korea, Republic of, 443-721
Peru
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Callao, Lima, Peru, Callao 2
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Arequipa, Peru, 54
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Ica, Peru, 11
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Lima, Peru, Lima 1
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Lima, Peru, 01
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Lima, Peru, 17
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Piura, Peru
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Trujillo, Peru
Philippines
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Cebu City, Philippines, 6000
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Iloilo City, Philippines, 5000
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Makati City, Philippines, 1218
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Pasay, Philippines, 1300
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Tagbilaran City, Philippines, 6300
Russian Federation
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Nizhniy Novgorod, Russian Federation, 603126
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Saratov, Russian Federation, 410030
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St'Petersburg, Russian Federation, 194156
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Yaroslavl, Russian Federation, 150062
South Africa
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Port Elizabeth, Eastern Cape, South Africa, 6014
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Johannesburg, Gauteng, South Africa, 2013
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Lenasia, Gauteng, South Africa, 1827
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Pretoria, Gauteng, South Africa, 0084
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Durban, KwaZulu- Natal, South Africa, 4092
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Phoenix, KwaZulu- Natal, South Africa, 4068
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Houghton, South Africa, 2198
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Somerset West, South Africa, 07129
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Tygerberg, South Africa, 7505
Spain
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Alicante, Spain, 03114
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La Coruña, Spain, 15006
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Málaga, Spain, 29010
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Palma de Mallorca, Spain, 07014
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Santiago de Compostela, Spain, 15706
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Sevilla, Spain, 41003
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Torrevieja (Alicante), Spain, 03186
Taiwan
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 404
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Tainan, Taiwan, 71044
United Kingdom
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Coventry, West Midlands, United Kingdom, CV2 2DX
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Birmingham, United Kingdom, B9 5SS
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Hertfordshire, United Kingdom
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Hull, United Kingdom, HU3 2RW
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Livingston, United Kingdom, EH54 6PP
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London, United Kingdom, SE1 9NH
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Plymouth, United Kingdom, PL6 8BX
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
Last Updated: November 21, 2012
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 April 23, 2014