Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)

March 21, 2017 updated by: GlaxoSmithKline

AVANDIA CV Outcomes Study: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

This study will answer two separate questions.

The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

The second question will compare the effects of long-term supplementation of vitamin D on death and cancer

Study Overview

Status

Terminated

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1332

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1405
    - GSK Investigational Site
  - Salta, Argentina, 4400
    - GSK Investigational Site
  - San Miguel de Tucuman, Argentina, 4000
    - GSK Investigational Site
  - Zárate, Argentina, B2800DGH
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1090
    - GSK Investigational Site
  - Coronel Suarez, Buenos Aires, Argentina
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - GSK Investigational Site
  - San Nicolas, Buenos Aires, Argentina, B2900DMH
    - GSK Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2T 5C7
    - GSK Investigational Site
  - Calgary, Alberta, Canada, T3S OM3
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T5A 4L8
    - GSK Investigational Site
- British Columbia
  - Surrey, British Columbia, Canada, V3R 3P1
    - GSK Investigational Site
  - Vancouver, British Columbia, Canada, V6H 3X8
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 0R8
    - GSK Investigational Site
  - Winnipeg, Manitoba, Canada, R3E 3P4
    - GSK Investigational Site
  - Winnipeg, Manitoba, Canada, R2V 4W3
    - GSK Investigational Site
- Newfoundland and Labrador
  - Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - GSK Investigational Site
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - GSK Investigational Site
  - Brampton, Ontario, Canada, L6Z 4N5
    - GSK Investigational Site
  - Cambridge, Ontario, Canada, N1R 7L6
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8N 3Z5
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8L 2X2
    - GSK Investigational Site
  - Hamilton., Ontario, Canada, L8N 3X5
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 4V2
    - GSK Investigational Site
  - Mississauga, Ontario, Canada, L5M 2V8
    - GSK Investigational Site
  - Ohsweken, Ontario, Canada, N0A 1M0
    - GSK Investigational Site
  - Oshawa, Ontario, Canada, L1J 2K1
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1H 1A2
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1C 1S6
    - GSK Investigational Site
  - Thornhill, Ontario, Canada, L4J 8L7
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5C 2T2
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M4R 2G4
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M9L 1W9
    - GSK Investigational Site
- Quebec
  - Laval, Quebec, Canada, H7T 2P5
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H2W 1R7
    - GSK Investigational Site
  - Quebec City, Quebec, Canada, G1V 4G5
    - GSK Investigational Site
  - Quebec City, Quebec, Canada, G1J 1Z6
    - GSK Investigational Site
  - Quebec City, Quebec, Canada, G1L 3L5
    - GSK Investigational Site
  - Rimouski, Quebec, Canada, G5L 5T1
    - GSK Investigational Site
  - Saint-Georges, Quebec, Canada, G5Y 4T8
    - GSK Investigational Site
  - Sainte-Foy, Quebec, Canada, G1V 4G2
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - GSK Investigational Site
Chile
- - Osorno, Chile
    - GSK Investigational Site
  - Valdivia, Chile
    - GSK Investigational Site
  - Victoria, Chile
    - GSK Investigational Site
- Región De La Araucania
  - Temuco, Región De La Araucania, Chile
    - GSK Investigational Site
- Región Metro De Santiago
  - Santiago, Región Metro De Santiago, Chile
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile, 8330024
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile, 8331143
    - GSK Investigational Site
Colombia
- - Armenia, Colombia
    - GSK Investigational Site
  - Barrangquilla, Colombia
    - GSK Investigational Site
  - Barranquilla, Colombia
    - GSK Investigational Site
  - Bogota, Colombia
    - GSK Investigational Site
  - Bogotac, Colombia, 83012
    - GSK Investigational Site
  - Cali, Colombia
    - GSK Investigational Site
  - Cartagena, Colombia
    - GSK Investigational Site
  - Cartagena, Colombia, 71 31-315
    - GSK Investigational Site
  - Espinal, Colombia
    - GSK Investigational Site
  - Floridablanca, Colombia
    - GSK Investigational Site
  - Manizales, Colombia
    - GSK Investigational Site
  - Medellín, Colombia
    - GSK Investigational Site
  - Pereira, Colombia
    - GSK Investigational Site
Czech Republic
- - Havirov, Czech Republic, 736 01
    - GSK Investigational Site
  - Jihlava, Czech Republic, 586 01
    - GSK Investigational Site
  - Mestec Kralove, Czech Republic, 289 03
    - GSK Investigational Site
  - Ostrava, Czech Republic, 70030
    - GSK Investigational Site
  - Prague, Czech Republic, 181 00
    - GSK Investigational Site
  - Praha, Czech Republic, 102 00
    - GSK Investigational Site
  - Praha 4, Czech Republic, 140 21
    - GSK Investigational Site
  - Praha 5, Czech Republic, 150 00
    - GSK Investigational Site
  - Praha 5, Czech Republic, 158 00
    - GSK Investigational Site
  - Praha 6, Czech Republic, 160 00
    - GSK Investigational Site
  - Pribram 8, Czech Republic, 261 01
    - GSK Investigational Site
  - Rakovnik, Czech Republic, 269 01
    - GSK Investigational Site
  - Uherske Hradiste, Czech Republic, 68601
    - GSK Investigational Site
Denmark
- - Aarhus-N, Denmark, 8200
    - GSK Investigational Site
  - Frederiksberg, Denmark, 2000
    - GSK Investigational Site
  - Glostrup, Denmark, 2600
    - GSK Investigational Site
  - Hellerup, Denmark, 2900
    - GSK Investigational Site
  - Herlev, Denmark, DK-2730
    - GSK Investigational Site
  - Koebenhavn, Denmark, 2300
    - GSK Investigational Site
  - København NV, Denmark, 2400
    - GSK Investigational Site
  - Odense C, Denmark, 5000
    - GSK Investigational Site
  - Viborg, Denmark, 8800
    - GSK Investigational Site
Finland
- - Helsinski, Finland, 00260
    - GSK Investigational Site
  - Kuopio, Finland, 70210
    - GSK Investigational Site
  - Oulu, Finland, 90100
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10367
    - GSK Investigational Site
  - Berlin, Germany, 13125
    - GSK Investigational Site
  - Berlin, Germany, 10629
    - GSK Investigational Site
  - Berlin, Germany, 10787
    - GSK Investigational Site
  - Berlin, Germany, 13158
    - GSK Investigational Site
  - Hamburg, Germany, 22177
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Deggingen, Baden-Wuerttemberg, Germany, 73326
    - GSK Investigational Site
  - Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78048
    - GSK Investigational Site
  - Wangen, Baden-Wuerttemberg, Germany, 88239
    - GSK Investigational Site
  - Weinheim, Baden-Wuerttemberg, Germany, 69469
    - GSK Investigational Site
- Bayern
  - Augsburg, Bayern, Germany, 86150
    - GSK Investigational Site
  - Gars am Inn, Bayern, Germany, 83536
    - GSK Investigational Site
  - Haag, Bayern, Germany, 83527
    - GSK Investigational Site
  - Kuenzing, Bayern, Germany, 94550
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80339
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80809
    - GSK Investigational Site
  - Vilshofen, Bayern, Germany, 94474
    - GSK Investigational Site
  - Wallerfing, Bayern, Germany, 94574
    - GSK Investigational Site
- Brandenburg
  - Angermuende, Brandenburg, Germany, 16278
    - GSK Investigational Site
  - Elsterwerda, Brandenburg, Germany, 04910
    - GSK Investigational Site
  - Potsdam, Brandenburg, Germany, 14469
    - GSK Investigational Site
- Hessen
  - Grossalmerode, Hessen, Germany, 37247
    - GSK Investigational Site
  - Kelkheim, Hessen, Germany, 65779
    - GSK Investigational Site
- Niedersachsen
  - Winsen/Lohe, Niedersachsen, Germany, 21423
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
    - GSK Investigational Site
  - Bergkamen, Nordrhein-Westfalen, Germany, 59192
    - GSK Investigational Site
  - Dorsten, Nordrhein-Westfalen, Germany, 46282
    - GSK Investigational Site
  - Eschweiler, Nordrhein-Westfalen, Germany, 52249
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45355
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45329
    - GSK Investigational Site
  - Goch, Nordrhein-Westfalen, Germany, 47574
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Germany, 51069
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Germany, 50823
    - GSK Investigational Site
  - Witten, Nordrhein-Westfalen, Germany, 58455
    - GSK Investigational Site
- Rheinland-Pfalz
  - Ingelheim, Rheinland-Pfalz, Germany, 55218
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55116
    - GSK Investigational Site
  - Rhaunen, Rheinland-Pfalz, Germany, 55624
    - GSK Investigational Site
- Saarland
  - Neunkirchen, Saarland, Germany, 66539
    - GSK Investigational Site
- Sachsen
  - Borna, Sachsen, Germany, 04552
    - GSK Investigational Site
  - Delitzsch, Sachsen, Germany, 04509
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01099
    - GSK Investigational Site
  - Leipzg, Sachsen, Germany, 04109
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04103
    - GSK Investigational Site
  - Oschatz, Sachsen, Germany, 04758
    - GSK Investigational Site
  - Pirna, Sachsen, Germany, 01796
    - GSK Investigational Site
- Sachsen-Anhalt
  - Koethen, Sachsen-Anhalt, Germany, 06366
    - GSK Investigational Site
  - Schoenebeck, Sachsen-Anhalt, Germany, 39218
    - GSK Investigational Site
  - Wolmirstedt, Sachsen-Anhalt, Germany, 39326
    - GSK Investigational Site
  - Zerbst, Sachsen-Anhalt, Germany, 39261
    - GSK Investigational Site
India
- - Ahmedabad, India, 380006
    - GSK Investigational Site
  - Bangalore, India, 560 010
    - GSK Investigational Site
  - Bangalore, India, 560034
    - GSK Investigational Site
  - Banjara Hills PO, Hyderabad, India, 500 034
    - GSK Investigational Site
  - Belgaum, India, 590001
    - GSK Investigational Site
  - Chennai, India, 600 008
    - GSK Investigational Site
  - Chennai, India, 600 028
    - GSK Investigational Site
  - Cochin, India, 683572
    - GSK Investigational Site
  - Hyderabad, India, 500034
    - GSK Investigational Site
  - Karnal, India, 132001
    - GSK Investigational Site
  - Kerala, India, 688 524
    - GSK Investigational Site
  - Kochi, India, 682026
    - GSK Investigational Site
  - Kochi, India, 682 040
    - GSK Investigational Site
  - Kottyam, India, 686 027
    - GSK Investigational Site
  - Mumbai, India, 400007
    - GSK Investigational Site
  - Nasik, India, 422013
    - GSK Investigational Site
  - Nellore, India, 524001
    - GSK Investigational Site
  - Pune, India, 411004
    - GSK Investigational Site
  - Tamil Nadu, India, Trichy - 620 018
    - GSK Investigational Site
  - Trivandrum, India, 695607
    - GSK Investigational Site
  - Vijayawada, India, 520008
    - GSK Investigational Site
Italy
- - Chieri (Torino), Italy, 10023
    - GSK Investigational Site
- Lombardia
  - Milano (Milan), Lombardia, Italy, 20132
    - GSK Investigational Site
  - Sesto San Giovanni (MI), Lombardia, Italy, 20099
    - GSK Investigational Site
- Molise
  - Pozzilli (IS), Molise, Italy, 86077
    - GSK Investigational Site
Latvia
- - Cesis, Latvia, LV4100
    - GSK Investigational Site
  - Daugavpils, Latvia, LV5417
    - GSK Investigational Site
  - Jekabpils, Latvia, LV5201
    - GSK Investigational Site
  - Liepaja, Latvia, LV3401
    - GSK Investigational Site
  - Riga, Latvia, LV 1002
    - GSK Investigational Site
  - Riga, Latvia, LV1024
    - GSK Investigational Site
  - Riga, Latvia, LV 1011
    - GSK Investigational Site
  - Tukums, Latvia, LV 3100
    - GSK Investigational Site
Mexico
- - Aguascalientes, Mexico, 20230
    - GSK Investigational Site
  - Guadalajara, Mexico
    - GSK Investigational Site
  - Tampico, Mexico
    - GSK Investigational Site
- Baja California Norte
  - Tijuana, Baja California Norte, Mexico, 22010
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44600
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44150
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44380
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, CP 44340
    - GSK Investigational Site
  - Zapopan, Jalisco, Mexico, 45200
    - GSK Investigational Site
- Michoacán
  - Morelia, Michoacán, Mexico
    - GSK Investigational Site
- San Luis Potosí
  - San Luis Potosi, San Luis Potosí, Mexico, 78200
    - GSK Investigational Site
Netherlands
- - Amsterdam, Netherlands, 1061 AE
    - GSK Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - GSK Investigational Site
  - Hoofddorp, Netherlands, 2134
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3015 CE
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3045 PM
    - GSK Investigational Site
Norway
- - Bodø, Norway, 8005
    - GSK Investigational Site
  - Hoenefoss, Norway, 3513
    - GSK Investigational Site
  - Kløfta, Norway, 2040
    - GSK Investigational Site
  - Oslo, Norway, 0160
    - GSK Investigational Site
  - Oslo, Norway, 0319
    - GSK Investigational Site
  - Oslo, Norway, 0514
    - GSK Investigational Site
  - Skedsmokorset, Norway, N-2020
    - GSK Investigational Site
  - Stavanger, Norway, 4005
    - GSK Investigational Site
  - Tromsø, Norway, 9038
    - GSK Investigational Site
  - Trondheim, Norway, 7212
    - GSK Investigational Site
Pakistan
- - Faisalabad, Pakistan, 37250
    - GSK Investigational Site
  - Islamabad, Pakistan, 44000
    - GSK Investigational Site
  - Lahore, Pakistan, 54000
    - GSK Investigational Site
Peru
- - Arequipa, Peru, 54
    - GSK Investigational Site
Philippines
- - Laoag City, Philippines, 2900
    - GSK Investigational Site
Romania
- - Bacau, Romania, 600114
    - GSK Investigational Site
  - Baia Mare, Romania, 435400
    - GSK Investigational Site
  - Bistrita, Romania, 420016
    - GSK Investigational Site
  - Brasov, Romania, 500365
    - GSK Investigational Site
  - Bucuresti, Romania, 020475
    - GSK Investigational Site
  - Buzau, Romania, 120203
    - GSK Investigational Site
  - Deva, Romania, 330084
    - GSK Investigational Site
  - Iasi, Romania, 700547
    - GSK Investigational Site
  - Oradea, Romania, 410469
    - GSK Investigational Site
  - Pitesti, Romania, 110084
    - GSK Investigational Site
  - Sibiu, Romania, 550245
    - GSK Investigational Site
Russian Federation
- - Arkhangelsk, Russian Federation, 163045
    - GSK Investigational Site
  - Barnaul, Russian Federation, 656 045
    - GSK Investigational Site
  - Barnaul, Russian Federation, 656038
    - GSK Investigational Site
  - Barnaul, Russian Federation, 656055
    - GSK Investigational Site
  - Ivanovo, Russian Federation, 153462
    - GSK Investigational Site
  - Ivanovo, Russian Federation, 153012
    - GSK Investigational Site
  - Kazan, Russian Federation, 420012
    - GSK Investigational Site
  - Kazan, Russian Federation, 420033
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650000
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650002
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650036
    - GSK Investigational Site
  - Kirov, Russian Federation, 610030
    - GSK Investigational Site
  - Kursk, Russian Federation, 305035
    - GSK Investigational Site
  - Moscow, Russian Federation, 129110
    - GSK Investigational Site
  - Moscow, Russian Federation, 111539
    - GSK Investigational Site
  - Moscow, Russian Federation, 121552
    - GSK Investigational Site
  - Moscow, Russian Federation, 125367
    - GSK Investigational Site
  - Moscow, Russian Federation, 117 036
    - GSK Investigational Site
  - Moscow, Russian Federation, 115487
    - GSK Investigational Site
  - Moscow, Russian Federation, 117556
    - GSK Investigational Site
  - Moscow, Russian Federation, 121 552
    - GSK Investigational Site
  - Moscow, Russian Federation, 123448
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603076
    - GSK Investigational Site
  - Nizhny Novgorod, Russian Federation, 603003
    - GSK Investigational Site
  - Ryazan, Russian Federation, 390026
    - GSK Investigational Site
  - Saint-Petersburg, Russian Federation, 197341
    - GSK Investigational Site
  - Saint-Petersburg, Russian Federation, 198260
    - GSK Investigational Site
  - Saratov, Russian Federation, 410031
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214 019
    - GSK Investigational Site
  - St Pertersburg, Russian Federation, 196247
    - GSK Investigational Site
  - St Petersberg, Russian Federation, 192288
    - GSK Investigational Site
  - St'Petersburg, Russian Federation, 194156
    - GSK Investigational Site
  - St'Petersburg, Russian Federation, 197110
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 194017
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 193312
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 195067
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 195197
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 198205
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 197758
    - GSK Investigational Site
  - Syktyvkar, Russian Federation, 167 981
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634063
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634050
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634012
    - GSK Investigational Site
  - Vladivostok, Russian Federation, 690034
    - GSK Investigational Site
  - Vladivostok, Russian Federation, 690105
    - GSK Investigational Site
  - Volgograd, Russian Federation, 400008
    - GSK Investigational Site
  - Voronezh, Russian Federation, 394018
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150003
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 826 06
    - GSK Investigational Site
  - Bratislava, Slovakia, 831 01
    - GSK Investigational Site
  - Nitra, Slovakia, 949 11
    - GSK Investigational Site
South Africa
- - Bellville, South Africa, 7531
    - GSK Investigational Site
  - Benoni, South Africa, 1501
    - GSK Investigational Site
  - Bloemfontein, South Africa, 9301
    - GSK Investigational Site
  - Cape Town, South Africa, 7500
    - GSK Investigational Site
  - Cape Town, South Africa, 7800
    - GSK Investigational Site
  - Durban, South Africa, 4001
    - GSK Investigational Site
  - Newton, South Africa, 2113
    - GSK Investigational Site
  - Observatory, South Africa, 7925
    - GSK Investigational Site
  - Parktown, South Africa, 2193
    - GSK Investigational Site
  - Pretoria, South Africa, 0002
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
  - Soweto, South Africa, 2013
    - GSK Investigational Site
  - Soweto, South Africa, 1111
    - GSK Investigational Site
  - Worcester, South Africa, 6850
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6014
    - GSK Investigational Site
- Gauteng
  - Meyerspark, Gauteng, South Africa, 0184
    - GSK Investigational Site
  - Parktown, Gauteng, South Africa, 2193
    - GSK Investigational Site
- KwaZulu- Natal
  - Chatsworth, KwaZulu- Natal, South Africa, 4092
    - GSK Investigational Site
  - Umhlanga Rocks, KwaZulu- Natal, South Africa, 4320
    - GSK Investigational Site
Sweden
- - Eksjö, Sweden, SE-575 36
    - GSK Investigational Site
  - Göteborg, Sweden, SE-413 45
    - GSK Investigational Site
  - Göteborg, Sweden, SE-416 85
    - GSK Investigational Site
  - Göteborg, Sweden, SE-417 17
    - GSK Investigational Site
  - Härnösand, Sweden, SE-871 82
    - GSK Investigational Site
  - Karlshamn, Sweden, SE-374 80
    - GSK Investigational Site
  - Kristianstad, Sweden, SE-291 85
    - GSK Investigational Site
  - Ljungby, Sweden, SE-341 82
    - GSK Investigational Site
  - Malmö, Sweden, SE-205 02
    - GSK Investigational Site
  - Malmö, Sweden, SE-214 22
    - GSK Investigational Site
  - Oskarshamn, Sweden, SE-572 28
    - GSK Investigational Site
  - Skene, Sweden, SE-511 62
    - GSK Investigational Site
  - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
  - Stockholm, Sweden, SE-111 57
    - GSK Investigational Site
  - Vällingby, Sweden, SE-162 68
    - GSK Investigational Site
  - Växjö, Sweden, SE-351 85
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
United Kingdom
- - Chippenham, United Kingdom, SN15 2SB
    - GSK Investigational Site
  - Doncaster, United Kingdom, DN9 1EP
    - GSK Investigational Site
  - Harrogate, United Kingdom, HG1 5JP
    - GSK Investigational Site
  - London, United Kingdom, E1 1BB
    - GSK Investigational Site
  - Manchester, United Kingdom, M13 9WL
    - GSK Investigational Site
  - Sheffield, United Kingdom, S10 2RX
    - GSK Investigational Site
- Somerset
  - Bath, Somerset, United Kingdom, BA1 3NG
    - GSK Investigational Site
United States
- California
  - Long Beach, California, United States, 90822
    - GSK Investigational Site
  - Los Angeles, California, United States, 90033
    - GSK Investigational Site
  - Northridge, California, United States, 91324
    - GSK Investigational Site
  - San Diego, California, United States, 92109
    - GSK Investigational Site
- Georgia
  - Decatur, Georgia, United States, 30033
    - GSK Investigational Site
  - Tucker, Georgia, United States, 30084
    - GSK Investigational Site
- Idaho
  - Pocatella, Idaho, United States, 83209
    - GSK Investigational Site
  - Pocatello, Idaho, United States, 83201
    - GSK Investigational Site
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - GSK Investigational Site
- Massachusetts
  - Haverhill, Massachusetts, United States, 1830
    - GSK Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - GSK Investigational Site
- Missouri
  - St. Louis, Missouri, United States, 63106
    - GSK Investigational Site
- Montana
  - Kalispell, Montana, United States, 59901
    - GSK Investigational Site
- New York
  - Westfield, New York, United States, 14787
    - GSK Investigational Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - GSK Investigational Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97239
    - GSK Investigational Site
  - Portland, Oregon, United States, 97216
    - GSK Investigational Site
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38104
    - GSK Investigational Site
- Texas
  - Dallas, Texas, United States, 75246
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Temple, Texas, United States, 76508
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose greater than or equal to 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) greater than or equal to 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of 6%) within one month of screening
Age ≥ 50 years and evidence of vascular disease defined as ≥1of:
- prior myocardial infarction
- prior stroke
- coronary, carotid or peripheral artery revascularization ≥ 4 years earlier
- previous documented myocardial ischemia on either an exercise stress test or on any cardiac imaging, or previous unstable angina with ECG changes or cardiac enzyme elevation OR
Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of:
- microalbuminuria or proteinuria
- history of treated or untreated hypertension with left ventricular hypertrophy by electrocardiogram (ECG) or echocardiogram
  - 50% stenosis on any imaging of coronary, carotid or lower extremity arteries
- ankle/brachial index <0.9 OR
Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:
- current tobacco use
- LDL-c ≥3.4 mmol/L (130 mg/dL) or on a lipid lowering medication
- HDL-c < 1.0 mmol/L (40 mg/dL) for men and < 1.3 mmol/L (50 mg/dL) for women or triglycerides ≥ 2.3 mmol/L (200 mg/dL)
- BP lowering medication use or untreated SBP ≥ 140 mmHg or DBP ≥ 95 mmHg
- Waist to hip ratio > 1.0 for men and > 0.8 for women
On no insulin and on less than or equal to 2 anti-diabetes drugs where at least one drug is at or below the half-maximal dose (as indicated in the MOP) with stable dosing for 10 weeks prior to screening

Exclusion Criteria:

Type 1 diabetes
Current need for insulin treatment
Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
An acute cardiovascular event within 30 days prior to randomization
Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction < 0.4 or current use of loop diuretics
Any fracture within the past 1 year
Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
Coronary, carotid or peripheral artery revascularization within the 4 years prior to screening in the absence of angina, MI, or stroke in the intervening period
End stage renal disease requiring renal replacement therapy
Receiving drug therapy to treat liver disease
A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 2.5 times the upper limit of normal
A prior heart transplant or awaiting a heart transplant
Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication for vitamin D therapy
Regular use of or indication for greater than 400IU of vitamin D daily
Clinically or medically unstable with expected survival < 1 year
Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant's data
Any other factor likely to limit protocol compliance or reporting of adverse events
Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
Contraindications to or history of hypersensitivity to the investigational products
History of renal stones within the past 2 years
Participation in another clinical trial of an investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pioglitazone PIO tablet was administered in the dose of 30 milligrams (mg) OD initially and could be titrated to a maximum dose of 45 mg at or after the 6-month visit. After 1 year of treatment, the dose of PIO was increased to 45 mg OD for the duration of 5.5 years.	Drug: pioglitazone Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.
Active Comparator: rosiglitazone RSG tablet was administered in the dose of 4 mg OD initially and could be titrated to a maximum dose of 8 mg at or after the 6-month visit. After 1 year of treatment, the dose of RSG was increased to 8 mg OD for the duration of 5.5 years.	Drug: rosiglitazone Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.
Placebo Comparator: TZD placebo Matching placebo tablet was administered once a day (OD) for the duration of 5.5 years	Drug: placebo Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.
Active Comparator: Vitamin D Active comparator	Dietary supplement: Vitamin D Vitamin D factor intervention
Placebo Comparator: Vitamin D placebo Placebo Comparator	Dietary supplement: Placebo Vitamin D factor intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) Time Frame: From Randomization at Visit 3 up to the Final Visit (average of 162 days)	An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).	From Randomization at Visit 3 up to the Final Visit (average of 162 days)
Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.	From Randomization at Visit 3 to Final Visit (up to 162 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Revascularization Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Need for Hospitalization for Any Reason Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Composite Microvascular Outcome Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia) Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Clinical Proteinuria Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With a Fracture Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. "Liver function test abnormal" and "hepatic enzyme increased" were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).	From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of Participants With Erectile Dysfunction Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Mean Score on Euro-QoL (EQ)-5D Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from "0" to "1", whereby a score of "1" represents the best health state imaginable and "0" represents a health state equivalent to being dead. Negative states are those worse than being dead.	From Randomization at Visit 3 to Final Visit (up to 162 days)
Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF) Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days)	CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.	From Randomization at Visit 3 to Final Visit (up to 162 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Cardiovascular Outcomes

Additional Relevant MeSH Terms

Other Study ID Numbers

111960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Statistical Analysis Plan
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 111960

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)

AVANDIA CV Outcomes Study: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents