A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

NCT00909597 | Completed Phase 3

• 2 other identifiers: BC218932009-009157-24
• Study Type: interventional
• Target: 756
• Locations: 19 countries
• Sites: 147

Brief Summary

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in HbA1c

  24 weeks

Secondary Outcomes (3)

• Proportion of patients achieving target HbA1c <=6.5%, <=7%

  weeks 24, 52 and 104

• Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose

  weeks 24, 52 and 104

• Adverse events; laboratory parameters; cardiovascular events

  At each clinic visit up to 106 weeks

Study Arms (3)

pioglitazone

ACTIVE COMPARATOR

Drug: pioglitazone

taspoglutide 10mg

EXPERIMENTAL

taspoglutide 10mg sc weekly

Drug: taspoglutide

taspoglutide 10mg/20mg

EXPERIMENTAL

taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly

Drug: taspoglutide

Interventions

pioglitazone DRUG

30mg po once daily for 4 weeks, followed by 45mg once daily

pioglitazone

taspoglutide DRUG

10mg sc once weekly

taspoglutide 10mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus;
• treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening;
• HbA1c \>=7.0% and \<=10% at screening;
• stable weight +/-5% for \>=12 weeks prior to screening.

You may not qualify if:

• type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
• clinically significant diabetic complications;
• clinically symptomatic gastrointestinal disease;
• \>3 episodes of severe hypoglycemia within 6 months before screening.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (147)

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Buena Park, California, 90620, United States

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Chino, California, 91710, United States

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Los Angeles, California, 90057, United States

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Rancho Cucamonga, California, 91730, United States

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Roseville, California, 95661, United States

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Santa Ana, California, 92701, United States

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Chiefland, Florida, 32626, United States

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Coral Gables, Florida, 33134, United States

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Daytona Beach, Florida, 32117, United States

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Panama City, Florida, 32401, United States

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Port Charlotte, Florida, 33948, United States

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St. Petersburg, Florida, 33716, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30338, United States

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Columbus, Georgia, 31904, United States

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Conyers, Georgia, 30094, United States

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Roswell, Georgia, 30076, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610-4319, United States

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Springfield, Illinois, 62704-1433, United States

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Evansville, Indiana, 47714, United States

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Madisonville, Kentucky, 42431, United States

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Metairie, Louisiana, 70006, United States

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Bethesda, Maryland, 20817, United States

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Ayer, Massachusetts, 01432, United States

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Waltham, Massachusetts, 02453, United States

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Ferndale, Michigan, 48220, United States

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Minneapolis, Minnesota, 55416, United States

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Biloxi, Mississippi, 39531, United States

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Jackson, Mississippi, 39216, United States

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Olive Branch, Mississippi, 38654, United States

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Grand Island, Nebraska, 68803, United States

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Berlin, New Jersey, 08009, United States

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Brick, New Jersey, 08724, United States

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Toms River, New Jersey, 08753, United States

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Trenton, New Jersey, 08611, United States

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New York, New York, 10021, United States

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Staten Island, New York, 10301, United States

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Durham, North Carolina, 27713, United States

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Mooresville, North Carolina, 28117, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Bend, Oregon, 97701, United States

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Medford, Oregon, 97504, United States

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Beaver, Pennsylvania, 15009, United States

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Philadelphia, Pennsylvania, 19107, United States

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Scranton, Pennsylvania, 18510, United States

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Kingsport, Tennessee, 37660, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77074, United States

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Salt Lake City, Utah, 84107, United States

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South Burlington, Vermont, 05403, United States

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Richmond, Virginia, 23226, United States

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Richmond, Virginia, 23249, United States

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Spokane, Washington, 99202, United States

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Vancouver, Washington, 98664, United States

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Waukesha, Wisconsin, 53189, United States

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Camperdown, New South Wales, 2050, Australia

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Wollongong, New South Wales, 2500, Australia

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Fortaleza, Ceará, 60430-370, Brazil

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Lago Sul, Federal District, 71625009, Brazil

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Marília, São Paulo, 17519030, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04020-050, Brazil

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São Paulo, São Paulo, 04022-001, Brazil

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Sorocaba, São Paulo, 18047-360, Brazil

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Vancouver, British Columbia, V6H 3X8, Canada

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Etobicoke, Ontario, M9R 4E1, Canada

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London, Ontario, N6A 5R8, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Toronto, Ontario, M9W 4L6, Canada

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San José, 4395-1000, Costa Rica

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San José, 755-1000, Costa Rica

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Besançon, 25030, France

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Corbeil-Essonnes, 91106, France

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Dommartin-lès-Toul, 54200, France

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La Rochelle, 17019, France

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Lille, 59037, France

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Poitiers, 86021, France

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Vénissieux, 69200, France

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Berlin, 10115, Germany

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Essen, 45359, Germany

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Falkensee, 14612, Germany

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Mainz, 55116, Germany

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Münster, 48145, Germany

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Rodgau, 63110, Germany

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Siegen, 57074, Germany

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Sulzbach-Rosenberg, 92237, Germany

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Wangen, 88239, Germany

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Aguascaliente, 20230, Mexico

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Celaya, 38000, Mexico

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Cuernavaca, 62250, Mexico

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Guadalajara, 44100, Mexico

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Guadalajara, 44650, Mexico

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Mexico City, 06700, Mexico

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Monterrey, 64460, Mexico

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Auckland, 1640, New Zealand

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Auckland, New Zealand

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San Isidro, 27, Peru

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Gdansk, 80-858, Poland

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Krakow, 30-015, Poland

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Krakow, 31-455, Poland

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Lublin, 20-044, Poland

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Lublin, 20-538, Poland

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Wroclaw, 50-044, Poland

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Rio Piedras, 00926, Puerto Rico

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Moscow, 117036, Russia

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Moscow, 121069, Russia

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Moscow, 127299, Russia

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Penza, 440026, Russia

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S.Petersburg, 194017, Russia

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Saint Petersburg, 193012, Russia

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Saint Petersburg, 194156, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 195057, Russia

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Saint Petersburg, 197022, Russia

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Saratov, 140018, Russia

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Voronezh, 394018, Russia

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Yaroslavl, 150023, Russia

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Yaroslavl, 150062, Russia

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Bratislava, 851 01, Slovakia

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Dolný Kubín, 026 01, Slovakia

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Levice, 034 01, Slovakia

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Levice, 93405, Slovakia

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Cape Town, 7130, South Africa

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Almería, Almeria, 04001, Spain

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Barcelona, Barcelona, 08907, Spain

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Pamplona, Navarre, 31008, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Chiang Mai, 50200, Thailand

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Pathum Thani, 12120, Thailand

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Songkhla, 90112, Thailand

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Kiev, 04050, Ukraine

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Odesa, 65009, Ukraine

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Odesa, 65117, Ukraine

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Vinnitsa, 21010, Ukraine

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Atherstone, CV9 1EU, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Chesterfield, S40 4TF, United Kingdom

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Dumfries, DG1 4AP, United Kingdom

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Glasgow, G45 9AW, United Kingdom

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Hinckley, LE10 2SE, United Kingdom

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Reading, RG7 3SQ, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; taspoglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (2); BR (9); ZA (1); PR (1); PE (1); AU (2); FR (7); TH (3); GB (7); ME (7); DE (9); CA (6); CO (2); UA (4); PL (6); US (57); RU (14); ES (5); SL (4)