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FDA has placed the trial on full clinical hold.
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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Active Comparator | 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. |
|
| rosiglitazone | Active Comparator | 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. |
|
| TZD placebo | Placebo Comparator | Matching placebo tablet was administered once a day (OD) for the duration of 5.5 years |
|
| Vitamin D | Active Comparator | Active comparator |
|
| Vitamin D placebo | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Randomization at Visit 3 to Final Visit (up to 162 days) |
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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:
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
ankle/brachial index <0.9 OR
Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90822 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23740195 | Derived | 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. | |
| 22038523 | Derived | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111960 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Randomization occurred subsequent to a 3-week rosiglitazone (RSG) and vitamin D Single-blind Run-in Phase to assess compliance and tolerability. Participants received an RSG tablet (4 milligrams [mg]) and a vitamin D tablet (1000 international units [IU]) once a day.
1332 participants were included in the TZD randomization, and 1221 of 1332 participants were included in the Vitamin D randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days. |
| FG001 | Pioglitazone (PIO) | PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 TZD Randomization |
|
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| rosiglitazone | Drug | Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell. |
|
| placebo | Drug | Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend. |
|
| Vitamin D | Dietary Supplement | Vitamin D factor intervention |
|
| Placebo | Dietary Supplement | Vitamin D factor intervention |
|
| 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. | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) |
| Los Angeles |
| California |
| 90033 |
| United States |
| GSK Investigational Site | Northridge | California | 91324 | United States |
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| GSK Investigational Site | London | Ontario | N6A 4V2 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5M 2V8 | Canada |
| GSK Investigational Site | Ohsweken | Ontario | N0A 1M0 | Canada |
| GSK Investigational Site | Oshawa | Ontario | L1J 2K1 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1C 1S6 | Canada |
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| GSK Investigational Site | Thornhill | Ontario | L4J 8L7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4R 2G4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5C 2T2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9L 1W9 | Canada |
| GSK Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2W 1R7 | Canada |
| GSK Investigational Site | Québec | Quebec | G1J 1Z6 | Canada |
| GSK Investigational Site | Québec | Quebec | G1L 3L5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Rimouski | Quebec | G5L 5T1 | Canada |
| GSK Investigational Site | Saint-Georges | Quebec | G5Y 4T8 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| GSK Investigational Site | Temuco | Región de La Araucania | Chile |
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| GSK Investigational Site | Santiago | Región Metro de Santiago | 8331143 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
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| GSK Investigational Site | Prague | 181 00 | Czechia |
| GSK Investigational Site | Příbram | 261 01 | Czechia |
| GSK Investigational Site | Rakovník | 269 01 | Czechia |
| GSK Investigational Site | Uherské Hradiště | 68601 | Czechia |
| GSK Investigational Site | Aarhus N | 8200 | Denmark |
| GSK Investigational Site | Copenhagen | 2300 | Denmark |
| GSK Investigational Site | Frederiksberg | 2000 | Denmark |
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| GSK Investigational Site | Helsinski | 00260 | Finland |
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| GSK Investigational Site | Villingen-Schwenningen | Baden-Wurttemberg | 78048 | Germany |
| GSK Investigational Site | Wangen | Baden-Wurttemberg | 88239 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86150 | Germany |
| GSK Investigational Site | Gars Am Inn | Bavaria | 83536 | Germany |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Künzing | Bavaria | 94550 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80339 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80809 | Germany |
| GSK Investigational Site | Vilshofen | Bavaria | 94474 | Germany |
| GSK Investigational Site | Wallerfing | Bavaria | 94574 | Germany |
| GSK Investigational Site | Angermünde | Brandenburg | 16278 | Germany |
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| GSK Investigational Site | Potsdam | Brandenburg | 14469 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22177 | Germany |
| GSK Investigational Site | Großalmerode | Hesse | 37247 | Germany |
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| GSK Investigational Site | Winsen/Lohe | Lower Saxony | 21423 | Germany |
| GSK Investigational Site | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| GSK Investigational Site | Bergkamen | North Rhine-Westphalia | 59192 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50823 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Dorsten | North Rhine-Westphalia | 46282 | Germany |
| GSK Investigational Site | Eschweiler | North Rhine-Westphalia | 52249 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45329 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45355 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
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| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Leipzg | Saxony | 04109 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Oschatz | Saxony | 04758 | Germany |
| GSK Investigational Site | Pirna | Saxony | 01796 | Germany |
| GSK Investigational Site | Köthen | Saxony-Anhalt | 06366 | Germany |
| GSK Investigational Site | Schönebeck | Saxony-Anhalt | 39218 | Germany |
| GSK Investigational Site | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| GSK Investigational Site | Zerbst | Saxony-Anhalt | 39261 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10629 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany |
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| GSK Investigational Site | Brasov | 500365 | Romania |
| GSK Investigational Site | Bucharest | 020475 | Romania |
| GSK Investigational Site | Buzău | 120203 | Romania |
| GSK Investigational Site | Deva | 330084 | Romania |
| GSK Investigational Site | Iași | 700547 | Romania |
| GSK Investigational Site | Oradea | 410469 | Romania |
| GSK Investigational Site | Piteşti | 110084 | Romania |
| GSK Investigational Site | Sibiu | 550245 | Romania |
| GSK Investigational Site | Arkhangelsk | 163045 | Russia |
| GSK Investigational Site | Barnaul | 656 045 | Russia |
| GSK Investigational Site | Barnaul | 656038 | Russia |
| GSK Investigational Site | Barnaul | 656055 | Russia |
| GSK Investigational Site | Ivanovo | 153012 | Russia |
| GSK Investigational Site | Ivanovo | 153462 | Russia |
| GSK Investigational Site | Kazan' | 420012 | Russia |
| GSK Investigational Site | Kazan' | 420033 | Russia |
| GSK Investigational Site | Kemerovo | 650000 | Russia |
| GSK Investigational Site | Kemerovo | 650002 | Russia |
| GSK Investigational Site | Kemerovo | 650036 | Russia |
| GSK Investigational Site | Kirov | 610030 | Russia |
| GSK Investigational Site | Kursk | 305035 | Russia |
| GSK Investigational Site | Moscow | 111539 | Russia |
| GSK Investigational Site | Moscow | 115487 | Russia |
| GSK Investigational Site | Moscow | 117 036 | Russia |
| GSK Investigational Site | Moscow | 117556 | Russia |
| GSK Investigational Site | Moscow | 121 552 | Russia |
| GSK Investigational Site | Moscow | 121552 | Russia |
| GSK Investigational Site | Moscow | 123448 | Russia |
| GSK Investigational Site | Moscow | 125367 | Russia |
| GSK Investigational Site | Moscow | 129110 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603003 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603076 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603126 | Russia |
| GSK Investigational Site | Ryazan | 390026 | Russia |
| GSK Investigational Site | Saint Pertersburg | 196247 | Russia |
| GSK Investigational Site | Saint Petersberg | 192288 | Russia |
| GSK Investigational Site | Saint Petersburg | 193312 | Russia |
| GSK Investigational Site | Saint Petersburg | 194017 | Russia |
| GSK Investigational Site | Saint Petersburg | 195067 | Russia |
| GSK Investigational Site | Saint Petersburg | 195197 | Russia |
| GSK Investigational Site | Saint Petersburg | 197341 | Russia |
| GSK Investigational Site | Saint Petersburg | 197758 | Russia |
| GSK Investigational Site | Saint Petersburg | 198205 | Russia |
| GSK Investigational Site | Saint Petersburg | 198260 | Russia |
| GSK Investigational Site | Saratov | 410031 | Russia |
| GSK Investigational Site | Smolensk | 214 019 | Russia |
| GSK Investigational Site | St'Petersburg | 194156 | Russia |
| GSK Investigational Site | St'Petersburg | 197110 | Russia |
| GSK Investigational Site | Syktyvkar | 167 981 | Russia |
| GSK Investigational Site | Tomsk | 634012 | Russia |
| GSK Investigational Site | Tomsk | 634050 | Russia |
| GSK Investigational Site | Tomsk | 634063 | Russia |
| GSK Investigational Site | Vladivostok | 690034 | Russia |
| GSK Investigational Site | Vladivostok | 690105 | Russia |
| GSK Investigational Site | Volgograd | 400008 | Russia |
| GSK Investigational Site | Voronezh | 394018 | Russia |
| GSK Investigational Site | Yaroslavl | 150003 | Russia |
| GSK Investigational Site | Bratislava | 826 06 | Slovakia |
| GSK Investigational Site | Bratislava | 831 01 | Slovakia |
| GSK Investigational Site | Nitra | 949 11 | Slovakia |
| GSK Investigational Site | Port Elizabeth | Eastern Cape | 6014 | South Africa |
| GSK Investigational Site | Meyerspark | Gauteng | 0184 | South Africa |
| GSK Investigational Site | Parktown | Gauteng | 2193 | South Africa |
| GSK Investigational Site | Chatsworth | KwaZulu-Natal | 4092 | South Africa |
| GSK Investigational Site | Umhlanga | KwaZulu-Natal | 4320 | South Africa |
| GSK Investigational Site | Bellville | 7531 | South Africa |
| GSK Investigational Site | Benoni | 1501 | South Africa |
| GSK Investigational Site | Bloemfontein | 9301 | South Africa |
| GSK Investigational Site | Cape Town | 7500 | South Africa |
| GSK Investigational Site | Cape Town | 7800 | South Africa |
| GSK Investigational Site | Durban | 4001 | South Africa |
| GSK Investigational Site | Newton | 2113 | South Africa |
| GSK Investigational Site | Observatory | 7925 | South Africa |
| GSK Investigational Site | Parktown | 2193 | South Africa |
| GSK Investigational Site | Pretoria | 0002 | South Africa |
| GSK Investigational Site | Somerset West | 7130 | South Africa |
| GSK Investigational Site | Soweto | 1111 | South Africa |
| GSK Investigational Site | Soweto | 2013 | South Africa |
| GSK Investigational Site | Worcester | 6850 | South Africa |
| GSK Investigational Site | Eksjö | SE-575 36 | Sweden |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
| GSK Investigational Site | Gothenburg | SE-416 85 | Sweden |
| GSK Investigational Site | Gothenburg | SE-417 17 | Sweden |
| GSK Investigational Site | Härnösand | SE-871 82 | Sweden |
| GSK Investigational Site | Karlshamn | SE-374 80 | Sweden |
| GSK Investigational Site | Kristianstad | SE-291 85 | Sweden |
| GSK Investigational Site | Ljungby | SE-341 82 | Sweden |
| GSK Investigational Site | Malmö | SE-205 02 | Sweden |
| GSK Investigational Site | Malmö | SE-214 22 | Sweden |
| GSK Investigational Site | Oskarshamn | SE-572 28 | Sweden |
| GSK Investigational Site | Skene | SE-511 62 | Sweden |
| GSK Investigational Site | Stockholm | SE-111 57 | Sweden |
| GSK Investigational Site | Stockholm | SE-171 76 | Sweden |
| GSK Investigational Site | Vaxjo | SE-351 85 | Sweden |
| GSK Investigational Site | Vällingby | SE-162 68 | Sweden |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Bath | Somerset | BA1 3NG | United Kingdom |
| GSK Investigational Site | Chippenham | SN15 2SB | United Kingdom |
| GSK Investigational Site | Doncaster | DN9 1EP | United Kingdom |
| GSK Investigational Site | Harrogate | HG1 5JP | United Kingdom |
| GSK Investigational Site | London | E1 1BB | United Kingdom |
| GSK Investigational Site | Manchester | M13 9Wl | United Kingdom |
| GSK Investigational Site | Sheffield | S10 2RX | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111960 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Rosiglitazone (RSG) | RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days. |
| FG003 | Vitamin D Placebo | Vitamin D placebo administered for a mean duration of 162 days. |
| FG004 | Vitamin D | 1,000 IU/day administered for a mean duration of 162 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 Vitamin D Randomization |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days. |
| BG001 | Pioglitazone (PIO) | PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days. |
| BG002 | Rosiglitazone (RSG) | RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent-to-Treat (ITT) Population: all randomized participants | Posted | Number | participants | From Randomization at Visit 3 up to the Final Visit (average of 162 days) |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Number | participants | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint. | Posted | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint. | Posted | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint. | Posted | From Randomization at Visit 3 to Final Visit (up to 162 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint. | Posted | From Randomization at Visit 3 to Final Visit (up to 162 days) |
|
162 days for the TZD arm; 130 days for the vitamin D arm
Non-serious AE's were not analyzed including the Vitamin D Placebo and Vitamin D arms. As a result, data is presented as "0" participants at risk for both the Vitamin D Placebo and Vitamin D arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days. | 7 | 541 | 36 | 541 | ||
| EG001 | Pioglitazone | PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days. | 5 | 392 | 35 | 392 | ||
| EG002 | Rosiglitazone | RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days. | 2 | 399 | 21 | 399 | ||
| EG003 | Vitamin D Placebo | Vitamin D placebo administered for a mean duration of 162 days | 2 | 614 | 0 | 0 | ||
| EG004 | Vitamin D | 1,000 IU/day administered for a mean duration of 162 days. | 9 | 607 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Angioplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| |
| Pruritis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Edema | General disorders | MedDRA | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cardiac stress test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA | Systematic Assessment |
| |
| Echocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Ejection fraction abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA | Systematic Assessment |
| |
| Glycosylated hemoglobin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cancer | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin discoloration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
The intended duration of this study was approximately 5.5 years. However, the trial was stopped prematurely because of regulatory concerns after a mean of 162 days without consideration of the accrued data.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000077154 | Rosiglitazone |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
|
| Death |
|
| Male |
|
| Unknown |
|
| South Asian |
|
| Black African |
|
| Native South American |
|
| Other Asian |
|
| Native North American |
|
| Japanese |
|
| Arab/ Persian |
|
| Native Hawaiian/ Australian or Other Asian Pacific |
|
| Malays |
|
| Sub-Saharan African |
|
| Missing |
|
| CV Death |
|
| Non-Fatal MI |
|
| Non-Fatal Stroke |
|
| OG004 | Vitamin D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| VITAMIN D |
1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG003 | VITAMIN D PLACEBO | Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG003 |
| VITAMIN D PLACEBO |
Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG003 | VITAMIN D PLACEBO | Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
Vitamin D placebo administered for a mean duration of 162 days.
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
|
| OG003 | VITAMIN D PLACEBO | Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
| VITAMIN D PLACEBO |
Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|
| OG003 | VITAMIN D PLACEBO | Vitamin D placebo administered for a mean duration of 162 days. |
| OG004 | VITAMIN D | 1,000 IU/day administered for a mean duration of 162 days. |
|