A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
First received: February 5, 2009
Last updated: May 22, 2014
Last verified: April 2014
  Purpose

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and Week 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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c at Week 156 [ Time Frame: Baseline and Week 156 ] [ 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. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Baseline and 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 the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 [ Time Frame: Baseline and Week 156 ] [ 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 was calculated as the post-Baseline value minus the Baseline value.

  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.

  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.

  • Time to Hyperglycemia Rescue [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ] [ Designated as safety issue: No ]
    Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.

  • Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.

  • Change From Baseline in Body Weight at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.

  • Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.

  • Albiglutide Plasma Concentrations at Week 8 and Week 24 [ Time Frame: Weeks 8 and 24 ] [ Designated as safety issue: No ]
    Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.


Enrollment: 779
Study Start Date: February 2009
Study Completion Date: May 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide weekly injection
albiglutide weekly subcutaneous injection
Biological: albiglutide
albiglutide weekly injection
Active Comparator: insulin glargine
insulin glargine daily injection
Drug: insulin glargine
insulin glargine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • BMI 20-45kg/m2 inclusive

Exclusion Criteria:

  • females who are pregnant, lactating or within <6 weeks post-partum
  • current symptomatic heart failure (NYHA Class III-IV)
  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: NCT00838916

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Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
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Birmingham, Alabama, United States, 35205
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Birmingham, Alabama, United States, 35235
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Dothan, Alabama, United States, 36301
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Hueytown, Alabama, United States, 35023
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Mobile, Alabama, United States, 36617
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Tuscaloosa, Alabama, United States, 35406
United States, Arizona
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Chandler, Arizona, United States, 85224
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Gilbert, Arizona, United States, 85295
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Green Valley, Arizona, United States, 85614
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Phoenix, Arizona, United States, 85032
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Phoenix, Arizona, United States, 85051
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Tucson, Arizona, United States, 85745
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Tucson, Arizona, United States, 85712
United States, Arkansas
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Bull Shoals, Arkansas, United States, 72619
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Harrisburg, Arkansas, United States, 72432
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Hot Springs, Arkansas, United States, 71913
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72205
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Searcy, Arkansas, United States, 72143
United States, California
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Buena Park, California, United States, 90620
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Cathedral City, California, United States, 92234
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Chino, California, United States, 91710
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Chula Vista, California, United States, 91911
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Commerce, California, United States, 90040
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Escondido, California, United States, 92026
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Foothill Ranch, California, United States, 92610
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Fountain Valley, California, United States, 92708
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Fresno, California, United States, 93720
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Fullerton, California, United States, 92835
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Huntington Beach, California, United States, 92648
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Huntington Beach, California, United States, 92646
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Irvine, California, United States, 92618
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La Jolla, California, United States, 92037
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LaJolla, California, United States, 92037
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Lakewood, California, United States, 90712
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Loma Linda, California, United States, 92354
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Long Beach, California, United States, 90806
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90022
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Los Angeles, California, United States, 90025
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Los Angeles, California, United States, 90017
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Mission Viejo, California, United States, 92691
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Northridge, California, United States, 91325
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Palm Desert, California, United States, 92260
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Pasadena, California, United States, 91105
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Riverside, California, United States, 92506
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Sacramento, California, United States, 95825
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Sacramento, California, United States, 95821
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San Diego, California, United States, 92120
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San Diego, California, United States, 92117
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San Diego, California, United States, 92128
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Satna Monica, California, United States, 90404
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Spring Valley, California, United States, 91978
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Tarzana, California, United States, 91356
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Tustin, California, United States, 92780
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Victorville, California, United States, 92395
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Vista, California, United States, 92083
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West Hills, California, United States, 91307
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Denver, Colorado, United States, 80209
United States, Connecticut
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New Britain, Connecticut, United States, 06050
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Trumbull, Connecticut, United States, 06611
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Waterbury, Connecticut, United States, 06708
United States, Delaware
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Middletown, Delaware, United States, 19709
United States, Florida
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Boynton Beach, Florida, United States, 33426
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Boynton Beach, Florida, United States, 33437
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Clearwater, Florida, United States, 33756
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Clearwater, Florida, United States, 33765
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Cocoa, Florida, United States, 32927
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Cutler Bay, Florida, United States, 33189
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Deerfield Beach, Florida, United States, 33442
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Delray Beach, Florida, United States, 33445
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Edgewater, Florida, United States, 32132
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Fort Lauderdale, Florida, United States, 33316
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Gainesville, Florida, United States, 32605
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Hallandale Beach, Florida, United States, 33009
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Hialeah, Florida, United States, 33013
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Hialeah, Florida, United States, 33012
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Hollywood, Florida, United States, 33023
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Jacksonville, Florida, United States, 32205
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Lauderdale Lakes, Florida, United States, 33319
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Marianna, Florida, United States, 32446
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Miami, Florida, United States, 33156
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Miami, Florida, United States, 33135
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North Miami, Florida, United States, 33161
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32822
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Ormond Beach, Florida, United States, 32174
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Oviedo, Florida, United States, 32765
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Panama City, Florida, United States, 32401
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Pembroke Pines, Florida, United States, 33026
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Plantation, Florida, United States, 33317
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Ponte Verda, Florida, United States, 32081
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St. Cloud, Florida, United States, 34769
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St. Petersburg, Florida, United States, 33709
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Tampa, Florida, United States, 33603
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30338
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Atlanta, Georgia, United States, 30309
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Atlanta, Georgia, United States, 30308
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30312
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Atlanta, Georgia, United States, 30328
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Blue Ridge, Georgia, United States, 30513
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30032
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Savannah, Georgia, United States, 31406
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Savannah, Georgia, United States, 31419
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Snellville, Georgia, United States, 30078
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Honolulu, Hawaii, United States, 96813
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Honolulu, Hawaii, United States, 96814
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Boise, Idaho, United States, 83702
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Idaho Falls, Idaho, United States, 83404
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Aurora, Illinois, United States, 60504
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Chicago, Illinois, United States, 60607
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Evergreen Park, Illinois, United States, 60805
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Gurnee, Illinois, United States, 60031
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La Grange, Illinois, United States, 60525
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Naperville, Illinois, United States, 60564
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Peoria, Illinois, United States, 61602
United States, Indiana
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Avon, Indiana, United States, 46123
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Evansville, Indiana, United States, 47714
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Fishers, Indiana, United States, 46037
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Indianapolis, Indiana, United States, 46254
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La Porte, Indiana, United States, 46350
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Lafayette, Indiana, United States, 47904
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South Bend, Indiana, United States, 46614
United States, Iowa
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Council Bluffs, Iowa, United States, 51501
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Des Moines, Iowa, United States, 50314
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Dubuque, Iowa, United States, 52001
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Iowa City, Iowa, United States, 52243
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Waterloo, Iowa, United States, 50701
United States, Kansas
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Arkansas City, Kansas, United States, 67005
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Mission, Kansas, United States, 66202
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Newton, Kansas, United States, 67114
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Overland Park, Kansas, United States, 66211
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Topeka, Kansas, United States, 66606
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Wichita, Kansas, United States, 67211
United States, Kentucky
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Fort Mitchell, Kentucky, United States, 41017
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Lexington, Kentucky, United States, 40503
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Lexington, Kentucky, United States, 40504
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Louisville, Kentucky, United States, 40202
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Madisonville, Kentucky, United States, 42431
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Covington, Louisiana, United States, 70433
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Lake Charles, Louisiana, United States, 70601
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Shreveport, Louisiana, United States, 71115
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Shreveport, Louisiana, United States, 71101
United States, Maryland
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Baltimore, Maryland, United States, 21237
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Hyattsville, Maryland, United States, 20782
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Oxon Hill, Maryland, United States, 20745
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
United States, Michigan
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Bay City, Michigan, United States, 48706
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Benzonia, Michigan, United States, 49616
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Bloomfield Hills, Michigan, United States, 48302
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Cadillac, Michigan, United States, 49601
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Dearborn, Michigan, United States, 48124
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Interlochen, Michigan, United States, 49643
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Kalamazoo, Michigan, United States, 49009
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Kalamazoo, Michigan, United States, 49048
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St Clair Shores, Michigan, United States, 48081
United States, Minnesota
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Brooklyn Center, Minnesota, United States, 55430
United States, Mississippi
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Gulfport, Mississippi, United States, 39501
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Picayune, Mississippi, United States, 39466
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Rolling Fork, Mississippi, United States, 39159
United States, Missouri
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Chesterfield, Missouri, United States, 63017
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64106
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Kansas City, Missouri, United States
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St. Louis, Missouri, United States, 63117
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St. Louis, Missouri, United States, 63108
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West Plains, Missouri, United States, 65775
United States, Montana
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Butte, Montana, United States, 59701
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Great Falls, Montana, United States, 59405
United States, Nebraska
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Broken Bow, Nebraska, United States, 68822
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68131
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Omaha, Nebraska, United States, 68124
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Omaha, Nebraska, United States, 68134
United States, Nevada
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89130
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Las Vegas, Nevada, United States, 89103
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Las Vegas, Nevada, United States, 89128
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Las Vegas, Nevada, United States, 89102
United States, New Jersey
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Berlin, New Jersey, United States, 08009
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Elizabeth, New Jersey, United States, 07202
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Haddon Heights, New Jersey, United States, 08035
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Hainesport, New Jersey, United States, 08036
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New Brunswick, New Jersey, United States, 08903
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Stratford, New Jersey, United States, 08084
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
United States, New York
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New York, New York, United States, 10022
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North Massapequa, New York, United States, 11758
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Syracuse, New York, United States, 13210
United States, North Carolina
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Asheville, North Carolina, United States, 28803
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Burlington, North Carolina, United States, 27215
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Calabash, North Carolina, United States, 28467
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Fayetteville, North Carolina, United States, 28304
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Greensboro, North Carolina, United States, 27405
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Hickory, North Carolina, United States, 28601
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Lenoir, North Carolina, United States, 28645
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Mint HIll, North Carolina, United States, 28227
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Morehead City, North Carolina, United States, 28557
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Shelby, North Carolina, United States, 28150
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Tabor City, North Carolina, United States, 28463
United States, Ohio
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Akron, Ohio, United States, 44320
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Canal Fulton, Ohio, United States, 44614
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Cincinnati, Ohio, United States, 45245
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Cincinnati, Ohio, United States, 45227
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43213
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Columbus, Ohio, United States, 43212
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Dayton, Ohio, United States, 45439
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Dayton, Ohio, United States, 45432
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Kettering, Ohio, United States, 45429
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Mason, Ohio, United States, 45040
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Maumee, Ohio, United States, 43537-9402
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Thornville, Ohio, United States, 43076
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Oklahoma City, Oklahoma, United States, 73116
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Tulsa, Oklahoma, United States, 74136
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Tulsa, Oklahoma, United States, 74104
United States, Oregon
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Ashland, Oregon, United States, 97520
United States, Pennsylvania
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Bensalem, Pennsylvania, United States, 19020
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Carlisle, Pennsylvania, United States, 17013
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Downington, Pennsylvania, United States, 19335
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Harrisburg, Pennsylvania, United States, 17112
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Landsdale, Pennsylvania, United States, 19446
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Pittsburgh, Pennsylvania, United States, 15243
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Tipton, Pennsylvania, United States, 16684
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Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Columbia, South Carolina, United States, 29201
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Greenville, South Carolina, United States, 29615
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Greenville, South Carolina, United States, 29601
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Greer, South Carolina, United States, 29651
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Manning, South Carolina, United States, 29102
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Murrells Inlet, South Carolina, United States, 29576
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North Myrtle Beach, South Carolina, United States, 29582
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Orangeburg, South Carolina, United States, 29115
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Simpsonville, South Carolina, United States, 29681
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Taylors, South Carolina, United States, 29687
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37421
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Clarksville, Tennessee, United States, 37043
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Columbia, Tennessee, United States, 38401
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Fayetteville, Tennessee, United States, 37334
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Johnson City, Tennessee, United States, 37604
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McKenzie, Tennessee, United States, 38201
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Nashville, Tennessee, United States, 37203
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Tullahoma, Tennessee, United States, 37398
United States, Texas
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Arlington, Texas, United States, 76012
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Bedford, Texas, United States, 76201
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Cleburne, Texas, United States, 76033
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Corpus Christi, Texas, United States, 78404
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Corpus Christi, Texas, United States, 78414
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Dallas, Texas, United States, 75251
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75224
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75230
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Deer Park, Texas, United States, 77536
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El Paso, Texas, United States, 79925
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Fort Worth, Texas, United States, 76135
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77034
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77058
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Houston, Texas, United States, 77027
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Houston, Texas, United States, 77055
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Houston, Texas, United States, 77094
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Houston, Texas, United States, 77036
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77074
GSK Investigational Site
Hurst, Texas, United States, 76054
GSK Investigational Site
Katy, Texas, United States, 77450
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
GSK Investigational Site
Lewisville, Texas, United States, 75067
GSK Investigational Site
Midland, Texas, United States, 79705
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
GSK Investigational Site
Odessa, Texas, United States, 79761
GSK Investigational Site
San Antonio, Texas, United States, 78224
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78217
GSK Investigational Site
San Antonio, Texas, United States, 78218
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78258
GSK Investigational Site
San Antonio, Texas, United States, 78215
GSK Investigational Site
Schertz, Texas, United States, 78154
GSK Investigational Site
Sugar Land, Texas, United States, 77479
GSK Investigational Site
Sugarland, Texas, United States, 77479
United States, Utah
GSK Investigational Site
Bountiful, Utah, United States, 84010
GSK Investigational Site
Murray, Utah, United States, 84123
GSK Investigational Site
Orem, Utah, United States, 84058
GSK Investigational Site
Salt Lake City, Utah, United States, 84120
GSK Investigational Site
West Jordan, Utah, United States, 84088
GSK Investigational Site
West Valley City, Utah, United States, 84120
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site
Burke, Virginia, United States, 22015
GSK Investigational Site
Hampton, Virginia, United States, 23666
GSK Investigational Site
Manassas, Virginia, United States, 20110
GSK Investigational Site
Richmond, Virginia, United States, 23294
GSK Investigational Site
Suffolk, Virginia, United States, 23434
GSK Investigational Site
Weber City, Virginia, United States, 24290
United States, Washington
GSK Investigational Site
Renton, Washington, United States, 98057
GSK Investigational Site
Richland, Washington, United States, 99352
GSK Investigational Site
Selah, Washington, United States, 98942
GSK Investigational Site
Spokane, Washington, United States, 99216
GSK Investigational Site
Spokane, Washington, United States, 99208
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, West Virginia
GSK Investigational Site
Lewisburg, West Virginia, United States, 24901
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Russian Federation
GSK Investigational Site
Arkhangelsk, Russian Federation, 163045
GSK Investigational Site
Irkutsk, Russian Federation, 664003
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603126
GSK Investigational Site
Saratov, Russian Federation, 410030
GSK Investigational Site
Smolensk, Russian Federation, 214019
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, 01820
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2013
GSK Investigational Site
Lenasia, Gauteng, South Africa, 1827
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Pretoria, Gauteng, South Africa, 00083
GSK Investigational Site
Phoenix, KwaZulu- Natal, South Africa, 4068
GSK Investigational Site
Somerset West, Western Province, South Africa, 7129
GSK Investigational Site
Cape Town, South Africa, 7530
GSK Investigational Site
Kempton Park, South Africa, 1619
GSK Investigational Site
Parow, South Africa, 7505
United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
GSK Investigational Site
Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
GSK Investigational Site
Port Glasgow, Renfrewshire, United Kingdom, PA14 6HW
GSK Investigational Site
Coventry, West Midlands, United Kingdom, CV2 2DX
GSK Investigational Site
Liverpool, United Kingdom, L9 7AL
GSK Investigational Site
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
Study First Received: February 5, 2009
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014