Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01394952
First received: July 13, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.


Condition Intervention Phase
Cardiovascular Disease
Diabetes Mellitus, Type 2
Drug: Dulaglutide
Drug: Placebo
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: The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time from randomization to first occurrence of cardiovascular death, non fatal myocardial infarction, or non fatal stroke (a composite cardiovascular outcome) [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence after randomization of the composite microvascular endpoint [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
    Diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy

  • Time to first occurrence after randomization of first hospitalization for unstable angina [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • Time to first occurrence after randomization of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, individually [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • Time to all cause mortality [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • Time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 9622
Study Start Date: July 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.5 mg Dulaglutide
Administered subcutaneously, weekly for up to 8 years
Drug: Dulaglutide
Administered subcutaneously
Other Name: LY2189265
Placebo Comparator: Placebo
Administered subcutaneously, weekly for up to 8 years
Drug: Placebo
Administered subcutaneously
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
  • Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
  • On stable antihyperglycemic regimen for at least 3 months
  • Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

Exclusion Criteria:

  • Uncontrolled diabetes requiring immediate therapy
  • History of severe hypoglycemia in past year
  • Acute coronary or cerebrovascular event within past 2 months
  • Planned or anticipated revascularization procedure
  • History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
  • Pregnancy or planned pregnancy during the trial period
  • Completed or withdrawn from any study investigating dulaglutide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394952

  Hide Study Locations
Locations
United States, Alabama
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Mobile, Alabama, United States, 36606
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Pell City, Alabama, United States, 35128
United States, Arizona
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Phoenix, Arizona, United States, 85012
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Tucson, Arizona, United States, 85723
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Burlingame, California, United States, 94010
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Lakewood, California, United States, 90712
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90333
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Northridge, California, United States, 91325
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San Diego, California, United States, 92161
United States, Connecticut
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Waterbury, Connecticut, United States, 06708
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
United States, Florida
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Brandon, Florida, United States, 33511
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Miami, Florida, United States, 33125
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Palm Harbor, Florida, United States, 34684
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Plant City, Florida, United States, 33563
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Port Charlotte, Florida, United States, 33952
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West Palm Beach, Florida, United States, 33401
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Winter Haven, Florida, United States, 33880
United States, Georgia
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Lawrenceville, Georgia, United States, 30046
United States, Hawaii
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Honolulu, Hawaii, United States, 96814
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40502
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
United States, Michigan
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Detroit, Michigan, United States, 48202
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
United States, Missouri
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Columbia, Missouri, United States, 65212
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Kansas City, Missouri, United States, 64128
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St Louis, Missouri, United States, 63106
United States, Montana
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Kalispell, Montana, United States, 59901
United States, Nebraska
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Omaha, Nebraska, United States, 68105
United States, New Jersey
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Camden, New Jersey, United States, 08103
United States, New York
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Freash Meadows, New York, United States, 11365
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Rochester, New York, United States, 14607
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Westfield, New York, United States, 14787
United States, North Carolina
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Morehead City, North Carolina, United States, 28557
United States, Ohio
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Columbus, Ohio, United States, 43210
United States, Oregon
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Portland, Oregon, United States, 97239
United States, South Carolina
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Murrells Inlet, South Carolina, United States, 29576
United States, Tennessee
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Memphis, Tennessee, United States, 38104
United States, Texas
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Dallas, Texas, United States, 75246
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Houston, Texas, United States, 77030
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Lubbock, Texas, United States, 79423
United States, Utah
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Salt Lake City, Utah, United States, 84124
United States, Virginia
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Burke, Virginia, United States, 22015
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Charlottesville, Virginia, United States, 22903
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Norfolk, Virginia, United States, 23507
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Richmond, Virginia, United States, 23249
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Salem, Virginia, United States, 24153
United States, Washington
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Seattle, Washington, United States, 98105
Argentina
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Bahia Blanca, Argentina, 8000
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Buenos Aires, Argentina, C1119ACN
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Cipolletti, Argentina, 8324
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Ciudad De Parana, Argentina, E3100BBJ
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Coronel Suarez, Argentina, B7540GHD
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Corrientes, Argentina, 3400
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Córdoba, Argentina, 5000
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Junin, Argentina, B6000BHA
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La Plata, Argentina, B1900AVS
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Mar Del Plata, Argentina, B7600FZN
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Merlo, Argentina, B1722COV
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Quilmes, Argentina, 1878
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Rafaela Santa Fe, Argentina, S2300MMA
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Rosario, Argentina, 2000
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Salta, Argentina, CP4400
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San Miguel De Tucuman, Argentina, T4000NIL
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San Nicolas, Argentina, 2900
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Santa Fe, Argentina, S2000FWO
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Venado Tuerto, Argentina, S2600
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Villa Maria, Argentina, X5900JKA
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Zarate, Argentina, 2800
Australia, New South Wales
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St Leonards, New South Wales, Australia, 2065
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St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Milton, Queensland, Australia, 4064
Australia, South Australia
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Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Heidelberg Heights, Victoria, Australia, 3081
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Melbourne, Victoria, Australia, 3004
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Parkville, Victoria, Australia, 3050
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Brazil
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Belo Horizonte, Brazil, 30150240
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Brasilia, Brazil, 70390903
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Campina Grande Do Sul, Brazil, 83430000
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Campinas, Brazil, 13020421
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Curitiba, Brazil, 80010-030
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Porto Alegre, Brazil, 90110-270
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Rio De Janeiro, Brazil, 20211-340
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Sao Jose Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 04025-011
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Uberaba, Brazil, 38025-260
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Votuporanga, Brazil, 15500-003
Bulgaria
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Blagoevgrad, Bulgaria, 2700
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1142
Canada, Alberta
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Calgary, Alberta, Canada, T3G 0B4
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Spruce Grove, Alberta, Canada, T7X 2V2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 0R8
Canada, Ontario
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Brampton, Ontario, Canada, L6S 0C9
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Burlington, Ontario, Canada, L7M 4Y1
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Cambridge, Ontario, Canada, N1R 7L6
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Etobicoke, Ontario, Canada, M9R 4E1
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Hamilton, Ontario, Canada, L8S 3Z5
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A 4V2
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Markham, Ontario, Canada, L6B 0P9
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Oakville, Ontario, Canada, L6H 3P1
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Oshawa, Ontario, Canada, L1J 2K1
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Ottawa, Ontario, Canada, K1H 1A2
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Smiths Falls, Ontario, Canada, K7A 4W8
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Thornhill, Ontario, Canada, L4J1W3
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
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Gatineau, Quebec, Canada, J8Y6S9
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Granby, Quebec, Canada, J2G 8Z9
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H3A 1A1
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Quebec City, Quebec, Canada, G1N 4V3
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Sherbrooke, Quebec, Canada, J1H 4J6
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Ville De Quebec, Quebec, Canada, G1L 3L5
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Ville St-Laurent, Quebec, Canada, H4T 1Z9
Canada, Saskatchewan
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Esaskatoon, Saskatchewan, Canada, S7K 3H3
Canada
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Quebec, Canada, G1V 4G5
Chile
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Osomo, Chile
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Providencia, Chile, 7500520
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Santiago, Chile, 2570017
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Temuco, Chile, 4781173
Colombia
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Armenia, Colombia, 63001
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Barranquilla, Colombia, 1569
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Barrio Maridias, Colombia
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Bogota, Colombia, 80CO
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Cartagena, Colombia, 130010
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El Espinal, Colombia
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Floridablanca, Colombia, 68276
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Manizales, Colombia
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Medellin, Colombia, 5001
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Pereira, Colombia
Czech Republic
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Brno, Czech Republic, 66250
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Chomutov, Czech Republic, 43002
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Havirov, Czech Republic, 73601
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Jinocany, Czech Republic, 25225
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Ostrava, Czech Republic, 70200
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Prague, Czech Republic, 181 00
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Pribram, Czech Republic, 261 01
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Uherske Hradiste, Czech Republic, 68601
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Valasske Klobouky, Czech Republic, 76601
Germany
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Bad Oeynhausen, Germany, 32545
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Berlin, Germany, 13158
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Bochum, Germany, 44787
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Burg/Spreewald, Germany, 03096
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Dippoldiswalde, Germany, 01744
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Dresden, Germany, 01307
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Düsseldorf, Germany, 40210
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Essen, Germany, 45355
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Haag, Germany, 83527
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Ingelheim, Germany, 55218
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Künzing, Germany, 94550
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Leipzig, Germany, 04107
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Ludwigshafen, Germany, 67067
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Mainz, Germany, 55116
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Pirna, Germany, 01796
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Riesa, Germany, 01587
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Saarlouis, Germany, 66740
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Speyer, Germany, 67346
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Villingen-Schwenningen, Germany, 78048
Hungary
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1125
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Kaposvar, Hungary, 7400
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Kecskemet, Hungary, 6000
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Mosonmagyarovar, Hungary, 9200
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Nyiregyhaza, Hungary, 4400
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Szekesfehervar, Hungary, 8000
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Szekszard, Hungary, 7100
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Veszprem, Hungary, 8200
India
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Ahmedabad, India, 380006
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Amravati, India, 444601
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Bangalore, India, 560038
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Belgaum, India, 590001
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Bilaspur, India, 495006
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Hyderabaad, India, 500024
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Jaipur, India, 302001
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Kormangala, India, 560034
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Kottayam, India, 686027
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Lucknow, India, 226003
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Ludhiana, India, 141421
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Nagpur, India, 440017
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Nashik, India, 422001
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Nellore, India, 524001
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Pune, India, 411030
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Rajkot, India, 360005
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Thrissur, India, 680002
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Trichy, India, 620018
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Trivandrum, India, 695011
Korea, Republic of
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Busan, Korea, Republic of, 602-715
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Daegu, Korea, Republic of, 705-718
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Goyang, Korea, Republic of, 410-773
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Guri City, Korea, Republic of, 471-701
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Gwangju, Korea, Republic of, 501-757
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Seoul, Korea, Republic of, 137-701
Latvia
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Daugavpils, Latvia, LV -5417
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Jelgava, Latvia, LV 3000
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Liepaja, Latvia, LV3401
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Limbazi, Latvia, LV-4001
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Ogre, Latvia, LV-5001
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Riga, Latvia, LV-1002
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Tukums, Latvia, LV-3101
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Valmiera, Latvia, LV4201
Lithuania
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Kaunas, Lithuania, LT50184
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Klaipeda, Lithuania, LT94231
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Vilniuslt, Lithuania, LT03116
Mexico
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Aguascalientes, Mexico, 20234
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Cuernavaca, Mexico, 62250
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Culiacan, Mexico, 80020
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Guadalajara, Mexico, 44860
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Mexico City, Mexico, 06090
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Monterrey, Mexico, 64620
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Queretaro, Mexico, 76000
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Tijuana, Mexico, 22329
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Tlalpan, Mexico, 14000
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Toluca, Mexico, 50010
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Veracruz, Mexico, 91910
New Zealand
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Auckland, New Zealand, 1640
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Beckenham, Christchurch, New Zealand, 8024
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Christchurch, New Zealand, 8011
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Dunedin, New Zealand, 9012
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Hastings, New Zealand
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Papamoa, New Zealand, 3118
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Roslyn, New Zealand, 4414
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Rotorua, New Zealand, 3010
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Tauranga, New Zealand, 3112
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Waitakere, New Zealand, 0612
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Wellington, New Zealand, 6021
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Westown, New Zealand, 4310
Poland
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Bialystok, Poland, 15-435
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Losice, Poland, 08200
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Poznan, Poland, 61-655
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Pulawy, Poland, 24100
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Sobotka, Poland, 55050
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Warsaw, Poland, 03003
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Wroclaw, Poland, 50-127
Puerto Rico
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Bayamon, Puerto Rico, 00960
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Manati, Puerto Rico, 00674
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San Juan, Puerto Rico, 00917-3104
Romania
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Alba Lulia, Romania, 510053
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Bacau, Romania, 600164
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Brasov, Romania, 500365
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Bucharest, Romania, 010507
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Cluj-Napoca, Romania, 400349
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Constanta, Romania, 900591
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Craiova, Romania, 200642
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Deva, Romania, 330084
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Galati, Romania, 800371
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Iasi, Romania, 700111
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Maramures, Romania, 430123
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Oradea, Romania, 410169
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Pitesti, Romania, 110084
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Ploiesti, Romania, 100163
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Satu Mare, Romania, 440055
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Sibiu, Romania, 550245
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Timisoara, Romania, 300736
Russian Federation
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Chelyabinsk, Russian Federation, 454021
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Moscow, Russian Federation, 123423
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Novosibirsk, Russian Federation, 630087
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Saint Petersburg, Russian Federation, 194156
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Smolensk, Russian Federation, 214019
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Volgograd, Russian Federation, 400138
South Africa
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Benoni, South Africa, 1500
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7925
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Die Wilgers Ext 14, South Africa, 0041
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Durban, South Africa, 4001
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Grassy Park, South Africa, 7941
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Johannesburg, South Africa, 2193
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Lynnwood Ridge, South Africa, 0040
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Lyttleton, South Africa, 0140
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Parow, South Africa, 7505
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Rondebosh, South Africa, 7700
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Somerset West, South Africa, 7130
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Soweto, South Africa, 2013
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Tongaat, South Africa, 4400
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Worcester, South Africa, 6850
Spain
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Alicante, Spain, 03450
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Alzira, Spain, 46600
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Badalona, Spain, 08916
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Barcelona, Spain, 08022
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Centelles, Spain, 08540
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Lleida, Spain, 25198
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Palma De Mallorca, Spain, 07198
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Segovia, Spain, 40002
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Sevilla, Spain, 41009
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Valencia, Spain, 46014
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Vic, Spain, 08500
Sweden
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Aneby, Sweden, 57893
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Goteborg, Sweden, 41685
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Härnösand, Sweden, 87182
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Koping, Sweden, 73181
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Ljungby, Sweden, 341 82
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Ostersund, Sweden, 83183
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Skelleftea, Sweden, 93186
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Stockholm, Sweden, 17176
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Vaxjo, Sweden, 35185
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Vällingby, Sweden, 16268
Taiwan
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Kaohsiung Hsien, Taiwan, 833
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Sindian City, Taiwan, 23148
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Taichung City, Taiwan, 404
United Kingdom
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Bath, Avon, United Kingdom, BA2 3HT
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Middlesbrough, Cleveland, United Kingdom, TS4 3BW
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Hull, East Yorkshire, United Kingdom, HU3 2RW
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Oldham, Lancashire, United Kingdom, OL1 2JH
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Belfast, Northern Ireland, United Kingdom, BT16 0TH
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Ayr, Scotland, United Kingdom, KA6 6DX
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Dundee, Scotland, United Kingdom, DD1 9SY
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Edinburgh, Scotland, United Kingdom, EH4 2XU
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Inverness, Scotland, United Kingdom, IV2 3JH
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Sheffield, South Yorkshire, United Kingdom, S5 7AU
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Swansea, Wales, United Kingdom, SA6 6NL
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Antrim, United Kingdom, BT412RL
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Bath, United Kingdom, BA1 2SR
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Belfast, United Kingdom, BT12 6BA
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Londonderry, United Kingdom, BT47 6SB
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01394952     History of Changes
Other Study ID Numbers: 13438, H9X-MC-GBDJ
Study First Received: July 13, 2011
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: National Health and Medical Research Council
Brazil: Ministry of Health
Bulgaria: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Chile: Ministry of Health
Colombia: National Institutes of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Hungary: Scientific and Medical Research Council Ethics Committee
India: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Ministry of Health
New Zealand: Ministry of Health
Peru: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
South Africa: National Health Research Ethics Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Sweden: The National Board of Health and Welfare
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Canada: Canadian Institutes of Health Research
European Union: European Medicines Agency
Finland: Finnish Medicines Agency
Finland: Ministry of Social Affairs and Health
Ireland: Medical Ethics Research Committee
Ireland: Ministry of Health
Israel: Ministry of Health
Israel: Ethics Commission
Italy: Ethics Committee
Italy: Ministry of Health
Slovakia: State Institute for Drug Control
Ukraine: Ethics Committee
Ukraine: Ministry of Health

Keywords provided by Eli Lilly and Company:
Cardiovascular disease
Diabetes Mellitus
Dulaglutide

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014