AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4TIDENCT00879970

Thiazolidinedione Intervention With Vitamin D Evaluation

A Phase 4 study testing pioglitazone, rosiglitazone and Vitamin D in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 331 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
pioglitazone, rosiglitazone and Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,332 participants
Where
331 sitesin 25 countries
Study dates
May 2009to Nov 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

331 sites in 25 countries.

331 sites in 25 countries

Germany50 sites

  • GSK Investigational Site

    Angermünde, Brandenburg, 16278

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • GSK Investigational Site

    Bergkamen, North Rhine-Westphalia, 59192

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 10629

  • GSK Investigational Site

    Berlin, State of Berlin, 10787

  • GSK Investigational Site

    Berlin, State of Berlin, 13125

  • GSK Investigational Site

    Berlin, State of Berlin, 13158

  • GSK Investigational Site

    Borna, Saxony, 04552

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50823

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dorsten, North Rhine-Westphalia, 46282

  • GSK Investigational Site

    Dresden, Saxony, 01099

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Elsterwerda, Brandenburg, 04910

  • GSK Investigational Site

    Eschweiler, North Rhine-Westphalia, 52249

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45329

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Gars Am Inn, Bavaria, 83536

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Großalmerode, Hesse, 37247

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22177

  • GSK Investigational Site

    Ingelheim, Rhineland-Palatinate, 55218

  • GSK Investigational Site

    Kelkheim, Hesse, 65779

  • GSK Investigational Site

    Köthen, Saxony-Anhalt, 06366

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 80809

  • GSK Investigational Site

    Neunkirchen, Saarland, 66539

  • GSK Investigational Site

    Oschatz, Saxony, 04758

  • GSK Investigational Site

    Pirna, Saxony, 01796

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Schönebeck, Saxony-Anhalt, 39218

  • GSK Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78048

  • GSK Investigational Site

    Vilshofen, Bavaria, 94474

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Winsen/Lohe, Lower Saxony, 21423

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

  • GSK Investigational Site

    Wolmirstedt, Saxony-Anhalt, 39326

  • GSK Investigational Site

    Zerbst, Saxony-Anhalt, 39261

Other trials in Germany

Russia49 sites

  • GSK Investigational Site

    Arkhangelsk, 163045

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Barnaul, 656038

  • GSK Investigational Site

    Barnaul, 656055

  • GSK Investigational Site

    Ivanovo, 153012

  • GSK Investigational Site

    Ivanovo, 153462

  • GSK Investigational Site

    Kazan', 420012

  • GSK Investigational Site

    Kazan', 420033

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kemerovo, 650036

  • GSK Investigational Site

    Kirov, 610030

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 115487

  • GSK Investigational Site

    Moscow, 117 036

  • GSK Investigational Site

    Moscow, 117556

  • GSK Investigational Site

    Moscow, 121 552

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Moscow, 123448

  • GSK Investigational Site

    Moscow, 125367

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Nizhny Novgorod, 603003

  • GSK Investigational Site

    Nizhny Novgorod, 603076

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Saint Pertersburg, 196247

  • GSK Investigational Site

    Saint Petersberg, 192288

  • GSK Investigational Site

    Saint Petersburg, 193312

  • GSK Investigational Site

    Saint Petersburg, 194017

  • GSK Investigational Site

    Saint Petersburg, 195067

  • GSK Investigational Site

    Saint Petersburg, 195197

  • GSK Investigational Site

    Saint Petersburg, 197341

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    Saint Petersburg, 198205

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saratov, 410031

  • GSK Investigational Site

    Smolensk, 214 019

  • GSK Investigational Site

    St'Petersburg, 194156

  • GSK Investigational Site

    St'Petersburg, 197110

  • GSK Investigational Site

    Syktyvkar, 167 981

  • GSK Investigational Site

    Tomsk, 634012

  • GSK Investigational Site

    Tomsk, 634050

  • GSK Investigational Site

    Tomsk, 634063

  • GSK Investigational Site

    Vladivostok, 690034

  • GSK Investigational Site

    Vladivostok, 690105

  • GSK Investigational Site

    Volgograd, 400008

  • GSK Investigational Site

    Voronezh, 394018

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Canada35 sites

  • GSK Investigational Site

    Barrie, Ontario, L4M 7G1

  • GSK Investigational Site

    Brampton, Ontario, L6Z 4N5

  • GSK Investigational Site

    Calgary, Alberta, T2T 5C7

  • GSK Investigational Site

    Calgary, Alberta, T3S OM3

  • GSK Investigational Site

    Cambridge, Ontario, N1R 7L6

  • GSK Investigational Site

    Edmonton, Alberta, T5A 4L8

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3X5

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Laval, Quebec, H7T 2P5

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Montreal, Quebec, H2W 1R7

  • GSK Investigational Site

    Ohsweken, Ontario, N0A 1M0

  • GSK Investigational Site

    Oshawa, Ontario, L1J 2K1

  • GSK Investigational Site

    Ottawa, Ontario, K1C 1S6

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1A2

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z6

  • GSK Investigational Site

    Québec, Quebec, G1L 3L5

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Rimouski, Quebec, G5L 5T1

  • GSK Investigational Site

    Saint-Georges, Quebec, G5Y 4T8

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G2

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Surrey, British Columbia, V3R 3P1

  • GSK Investigational Site

    Thornhill, Ontario, L4J 8L7

  • GSK Investigational Site

    Toronto, Ontario, M4R 2G4

  • GSK Investigational Site

    Toronto, Ontario, M5C 2T2

  • GSK Investigational Site

    Toronto, Ontario, M9L 1W9

  • GSK Investigational Site

    Vancouver, British Columbia, V6H 3X8

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 0R8

  • GSK Investigational Site

    Winnipeg, Manitoba, R2V 4W3

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

United States23 sites

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Haverhill, Massachusetts, 1830

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Kalispell, Montana, 59901

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Long Beach, California, 90822

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Minneapolis, Minnesota, 55454

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    Northridge, California, 91324

  • GSK Investigational Site

    Pocatella, Idaho, 83209

  • GSK Investigational Site

    Pocatello, Idaho, 83201

  • GSK Investigational Site

    Portland, Oregon, 97216

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    San Diego, California, 92109

  • GSK Investigational Site

    St Louis, Missouri, 63106

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Tucker, Georgia, 30084

  • GSK Investigational Site

    Westfield, New York, 14787

Other trials in United States

India21 sites

  • GSK Investigational Site

    Ahmedabad, 380006

  • GSK Investigational Site

    Bangalore, 560 010

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Banjara Hills PO, Hyderabad, 500 034

  • GSK Investigational Site

    Belagavi, 590001

  • GSK Investigational Site

    Chennai, 600 008

  • GSK Investigational Site

    Chennai, 600 028

  • GSK Investigational Site

    Hyderabad, 500034

  • GSK Investigational Site

    Karnāl, 132001

  • GSK Investigational Site

    Kerala, 688 524

  • GSK Investigational Site

    Kochi, 682 040

  • GSK Investigational Site

    Kochi, 682026

  • GSK Investigational Site

    Kochi, 683572

  • GSK Investigational Site

    Kottyam, 686 027

  • GSK Investigational Site

    Mumbai, 400007

  • GSK Investigational Site

    Nashik, 422013

  • GSK Investigational Site

    Nellore, 524001

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Tamil Nadu, Trichy - 620 018

  • GSK Investigational Site

    Trivandrum, 695607

  • GSK Investigational Site

    Vijayawada, 520008

Other trials in India

South Africa19 sites

  • GSK Investigational Site

    Bellville, 7531

  • GSK Investigational Site

    Benoni, 1501

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7500

  • GSK Investigational Site

    Cape Town, 7800

  • GSK Investigational Site

    Chatsworth, KwaZulu-Natal, 4092

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Meyerspark, Gauteng, 0184

  • GSK Investigational Site

    Newton, 2113

  • GSK Investigational Site

    Observatory, 7925

  • GSK Investigational Site

    Parktown, Gauteng, 2193

  • GSK Investigational Site

    Parktown, 2193

  • GSK Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Soweto, 1111

  • GSK Investigational Site

    Soweto, 2013

  • GSK Investigational Site

    Umhlanga, KwaZulu-Natal, 4320

  • GSK Investigational Site

    Worcester, 6850

Other trials in South Africa

Sweden16 sites

  • GSK Investigational Site

    Eksjö, SE-575 36

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-416 85

  • GSK Investigational Site

    Gothenburg, SE-417 17

  • GSK Investigational Site

    Härnösand, SE-871 82

  • GSK Investigational Site

    Karlshamn, SE-374 80

  • GSK Investigational Site

    Kristianstad, SE-291 85

  • GSK Investigational Site

    Ljungby, SE-341 82

  • GSK Investigational Site

    Malmö, SE-205 02

  • GSK Investigational Site

    Malmö, SE-214 22

  • GSK Investigational Site

    Oskarshamn, SE-572 28

  • GSK Investigational Site

    Skene, SE-511 62

  • GSK Investigational Site

    Stockholm, SE-111 57

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Vällingby, SE-162 68

  • GSK Investigational Site

    Vaxjo, SE-351 85

Other trials in Sweden

Colombia13 sites

  • GSK Investigational Site

    Armenia

  • GSK Investigational Site

    Barrangquilla

  • GSK Investigational Site

    Barranquilla

  • GSK Investigational Site

    Bogotá

  • GSK Investigational Site

    Bogotac, 83012

  • GSK Investigational Site

    Cali

  • GSK Investigational Site

    Cartagena, 71 31-315

  • GSK Investigational Site

    Cartagena

  • GSK Investigational Site

    Espinal

  • GSK Investigational Site

    Floridablanca

  • GSK Investigational Site

    Manizales

  • GSK Investigational Site

    Medellín

  • GSK Investigational Site

    Pereira

Other trials in Colombia

Czechia13 sites

  • GSK Investigational Site

    Havířov, 736 01

  • GSK Investigational Site

    Jihlava, 586 01

  • GSK Investigational Site

    Městec Králové, 289 03

  • GSK Investigational Site

    Ostrava, 70030

  • GSK Investigational Site

    Prague, 102 00

  • GSK Investigational Site

    Prague, 140 21

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Prague, 158 00

  • GSK Investigational Site

    Prague, 160 00

  • GSK Investigational Site

    Prague, 181 00

  • GSK Investigational Site

    Příbram, 261 01

  • GSK Investigational Site

    Rakovník, 269 01

  • GSK Investigational Site

    Uherské Hradiště, 68601

Other trials in Czechia

Mexico11 sites

  • GSK Investigational Site

    Aguascalientes, 20230

  • GSK Investigational Site

    Guadalajara, Jalisco, 44150

  • GSK Investigational Site

    Guadalajara, Jalisco, 44380

  • GSK Investigational Site

    Guadalajara, Jalisco, 44600

  • GSK Investigational Site

    Guadalajara, Jalisco, CP 44340

  • GSK Investigational Site

    Guadalajara

  • GSK Investigational Site

    Morelia, Michoacán

  • GSK Investigational Site

    San Luis Potosí City, San Luis Potosí, 78200

  • GSK Investigational Site

    Tampico

  • GSK Investigational Site

    Tijuana, Baja California Norte, 22010

  • GSK Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Romania11 sites

  • GSK Investigational Site

    Bacau, 600114

  • GSK Investigational Site

    Baia Mare, 435400

  • GSK Investigational Site

    Bistriţa, 420016

  • GSK Investigational Site

    Brasov, 500365

  • GSK Investigational Site

    Bucharest, 020475

  • GSK Investigational Site

    Buzău, 120203

  • GSK Investigational Site

    Deva, 330084

  • GSK Investigational Site

    Iași, 700547

  • GSK Investigational Site

    Oradea, 410469

  • GSK Investigational Site

    Piteşti, 110084

  • GSK Investigational Site

    Sibiu, 550245

Other trials in Romania

Norway10 sites

  • GSK Investigational Site

    Bodø, 8005

  • GSK Investigational Site

    Hoenefoss, 3513

  • GSK Investigational Site

    Kløfta, 2040

  • GSK Investigational Site

    Oslo, 0160

  • GSK Investigational Site

    Oslo, 0319

  • GSK Investigational Site

    Oslo, 0514

  • GSK Investigational Site

    Skedsmokorset, N-2020

  • GSK Investigational Site

    Stavanger, 4005

  • GSK Investigational Site

    Tromsø, 9038

  • GSK Investigational Site

    Trondheim, 7212

Other trials in Norway

Denmark9 sites

  • GSK Investigational Site

    Aarhus N, 8200

  • GSK Investigational Site

    Copenhagen, 2300

  • GSK Investigational Site

    Frederiksberg, 2000

  • GSK Investigational Site

    Glostrup Municipality, 2600

  • GSK Investigational Site

    Hellerup, 2900

  • GSK Investigational Site

    Herlev, DK-2730

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Viborg, 8800

Other trials in Denmark

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1405

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1090

  • GSK Investigational Site

    Coronel Suárez, Buenos Aires

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Salta, 4400

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Nicolás de los Arroyos, Buenos Aires, B2900DMH

  • GSK Investigational Site

    Zárate, B2800DGH

Other trials in Argentina

Latvia8 sites

  • GSK Investigational Site

    Cēsis, LV4100

  • GSK Investigational Site

    Daugavpils, LV5417

  • GSK Investigational Site

    Jēkabpils, LV5201

  • GSK Investigational Site

    Liepāja, LV3401

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1011

  • GSK Investigational Site

    Riga, LV1024

  • GSK Investigational Site

    Tukums, LV 3100

Other trials in Latvia

Chile7 sites

  • GSK Investigational Site

    Osorno

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8330024

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8331143

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Temuco, Región de La Araucania

  • GSK Investigational Site

    Valdivia

  • GSK Investigational Site

    Victoria

Other trials in Chile

United Kingdom7 sites

  • GSK Investigational Site

    Bath, Somerset, BA1 3NG

  • GSK Investigational Site

    Chippenham, SN15 2SB

  • GSK Investigational Site

    Doncaster, DN9 1EP

  • GSK Investigational Site

    Harrogate, HG1 5JP

  • GSK Investigational Site

    London, E1 1BB

  • GSK Investigational Site

    Manchester, M13 9Wl

  • GSK Investigational Site

    Sheffield, S10 2RX

Other trials in United Kingdom

Netherlands5 sites

  • GSK Investigational Site

    Amsterdam, 1061 AE

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hoofddorp, 2134

  • GSK Investigational Site

    Rotterdam, 3015 CE

  • GSK Investigational Site

    Rotterdam, 3045 PM

Other trials in Netherlands

Italy4 sites

  • GSK Investigational Site

    Chieri (Torino), 10023

  • GSK Investigational Site

    Milano (Milan), Lombardy, 20132

  • GSK Investigational Site

    Pozzilli (IS), Molise, 86077

  • GSK Investigational Site

    Sesto San Giovanni (MI), Lombardy, 20099

Other trials in Italy

Finland3 sites

  • GSK Investigational Site

    Helsinski, 00260

  • GSK Investigational Site

    Kuopio, 70210

  • GSK Investigational Site

    Oulu, 90100

Other trials in Finland

Pakistan3 sites

  • GSK Investigational Site

    Faisalabad, 37250

  • GSK Investigational Site

    Islamabad, 44000

  • GSK Investigational Site

    Lahore, 54000

Other trials in Pakistan

Slovakia3 sites

  • GSK Investigational Site

    Bratislava, 826 06

  • GSK Investigational Site

    Bratislava, 831 01

  • GSK Investigational Site

    Nitra, 949 11

Other trials in Slovakia

Peru1 site

  • GSK Investigational Site

    Arequipa, Arequipa, 54

Other trials in Peru

Philippines1 site

  • GSK Investigational Site

    Laoag, 2900

Other trials in Philippines

Thailand1 site

  • GSK Investigational Site

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: 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

Being tested
pioglitazone, rosiglitazone, placebo, Vitamin D
Keywords
Cardiovascular Outcomes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pioglitazoneDrug

    Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

  • rosiglitazoneDrug

    Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

  • placeboDrug

    Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.

  • Vitamin DDietary supplement

    Vitamin D factor intervention

  • PlaceboDietary supplement

    Vitamin D factor intervention

Study groups in NCT00879970
Study groupRoleWhat they receive
pioglitazoneActive comparatorPIO 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.
Receives: Drug: pioglitazone
rosiglitazoneActive comparatorRSG 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.
Receives: Drug: rosiglitazone
TZD placeboPlacebo comparatorMatching placebo tablet was administered once a day (OD) for the duration of 5.5 years
Receives: Drug: placebo
Vitamin DActive comparatorActive comparator
Receives: Dietary Supplement: Vitamin D
Vitamin D placeboPlacebo comparatorPlacebo Comparator
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)

    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).

    Measured: From Randomization at Visit 3 up to the Final Visit (average of 162 days)

  2. Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

Secondary outcomes (13)

  1. Number of Participants With Any Revascularization

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  2. Number of Participants With Need for Hospitalization for Any Reason

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  3. Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  4. Number of Participants With Composite Microvascular Outcome

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  5. Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  6. Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  7. Number of Participants With Clinical Proteinuria

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  8. Number of Participants With a Fracture

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  9. Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  10. Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit

    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).

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  11. Number of Participants With Erectile Dysfunction

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  12. Mean Score on Euro-QoL (EQ)-5D

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

  13. Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)

    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.

    Measured: From Randomization at Visit 3 to Final Visit (up to 162 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: FDA has placed the trial on full clinical hold.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00879970
Sponsor's protocol ID
111960
Acronym
TIDE
Status last verified
Mar 2017
First submitted
2 Apr 2009
Last updated
18 Apr 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Punthakee Z, Bosch J, Gerstein HC. Setting the record straight on TIDE: a lost opportunity for patients with diabetes. Diabetologia. 2013 Sep;56(9):1884-7. doi: 10.1007/s00125-013-2959-0. Epub 2013 Jun 6.

    PubMed 23740195

  • Punthakee Z, Bosch J, Dagenais G, Diaz R, Holman R, Probstfield J, Ramachandran A, Riddle M, Ryden LE, Zinman B, Afzal R, Yusuf S, Gerstein H; TIDE Trial Investigators. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial. Diabetologia. 2012 Jan;55(1):36-45. doi: 10.1007/s00125-011-2357-4. Epub 2011 Oct 29.

    PubMed 22038523

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pioglitazone, rosiglitazone and Vitamin D in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 331 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 331 sites in Germany, Russia, Canada, United States, India and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00879970, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

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