Last updated: 11/07/2018 04:16:03
Thiazolidinedione Intervention with vitamin D EvaluationTIDE
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with the indicated components of the composite cardiovascular outcome for thiazolidinedione (TZD)
Timeframe: 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
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Secondary outcomes:
Number of participants with any revascularization
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with need for hospitalization for any reason
Timeframe: 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
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with composite microvascular outcome
Timeframe: 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
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with severe lower than normal blood glucose level (hypoglycemia)
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with clinical proteinuria
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with a fracture
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with hepatic enzyme increased or abnormal liver function tests
Timeframe: 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
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Number of participants with erectile dysfunction
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Mean score on Euro-QoL (EQ)-5D
Timeframe: 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)
Timeframe: From Randomization at Visit 3 to Final Visit (up to 162 days)
Interventions:
Enrollment:
1332
Primary completion date:
2010-22-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
The TIDE Investigators. Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE): A Randomized Controlled Trial. Diabetologia.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Academic Research Collaborator: Population Health Research Institute / Hamilton Health
Study date(s)
May 2009 to November 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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
- Type 1 diabetes
- Current need for insulin treatment
Inclusion and exclusion criteria
Inclusion criteria:
- Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose greater than or equal to 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) greater than or equal to 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
- Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of 6%) within one month of screening
- Age ≥ 50 years and evidence of vascular disease defined as ≥1of: --prior myocardial infarction --prior stroke --coronary, carotid or peripheral artery revascularization ≥ 4 years earlier --previous documented myocardial ischemia on either an exercise stress test or on any cardiac imaging, or previous unstable angina with ECG changes or cardiac enzyme elevation OR
- Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of: --microalbuminuria or proteinuria --history of treated or untreated hypertension with left ventricular hypertrophy by electrocardiogram (ECG) or echocardiogram -->50% stenosis on any imaging of coronary, carotid or lower extremity arteries --ankle/brachial index <0.9 OR
- Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors: --current tobacco use --LDL-c ≥3.4 mmol/L (130 mg/dL) or on a lipid lowering medication --HDL-c < 1.0 mmol/L (40 mg/dL) for men and < 1.3 mmol/L (50 mg/dL) for women or triglycerides ≥ 2.3 mmol/L (200 mg/dL) --BP lowering medication use or untreated SBP ≥ 140 mmHg or DBP ≥ 95 mmHg --Waist to hip ratio > 1.0 for men and > 0.8 for women
- On no insulin and on less than or equal to 2 anti-diabetes drugs where at least one drug is at or below the half-maximal dose (as indicated in the MOP) with stable dosing for 10 weeks prior to screening
Exclusion criteria:
- Type 1 diabetes
- Current need for insulin treatment
- Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
- An acute cardiovascular event within 30 days prior to randomization
- Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction < 0.4 or current use of loop diuretics
- Any fracture within the past 1 year
- Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
- Coronary, carotid or peripheral artery revascularization within the 4 years prior to screening in the absence of angina, MI, or stroke in the intervening period
- End stage renal disease requiring renal replacement therapy
- Receiving drug therapy to treat liver disease
- A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 2.5 times the upper limit of normal
- A prior heart transplant or awaiting a heart transplant
- Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication for vitamin D therapy
- Regular use of or indication for greater than 400IU of vitamin D daily
- Clinically or medically unstable with expected survival < 1 year
- Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant’s data
- Any other factor likely to limit protocol compliance or reporting of adverse events
- Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
- Contraindications to or history of hypersensitivity to the investigational products
- History of renal stones within the past 2 years
- Participation in another clinical trial of an investigational agent
Trial location(s)
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8330024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nizhniy Novgorod, Russia, 603126
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Eschweiler, Nordrhein-Westfalen, Germany, 52249
Status
Study Complete
Location
GSK Investigational Site
Pocatello, Idaho, United States, 83201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wallerfing, Bayern, Germany, 94574
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Uherske Hradiste, Czech Republic, 68601
Status
Study Complete
Location
GSK Investigational Site
Sesto San Giovanni (MI), Lombardia, Italy, 20099
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Banjara Hills PO, Hyderabad, India, 500 034
Status
Study Complete
Location
GSK Investigational Site
Westfield, New York, United States, 14787
Status
Study Complete
Location
GSK Investigational Site
San Nicolas, Buenos Aires, Argentina, B2900DMH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3X8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
Status
Study Complete
Location
GSK Investigational Site
Bergkamen, Nordrhein-Westfalen, Germany, 59192
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Rimouski, Québec, Canada, G5L 5T1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1090
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3R 3P1
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Chippenham, United Kingdom, SN15 2SB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Luis Potosi, San Luis PotosÃ, Mexico, 78200
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Umhlanga Rocks, KwaZulu- Natal, South Africa, 4320
Status
Study Complete
Location
GSK Investigational Site
Pozzilli (IS), Molise, Italy, 86077
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tijuana, Baja California Norte, Mexico, 22010
Status
Study Complete
Location
GSK Investigational Site
Saint-Georges, Québec, Canada, G5Y 4T8
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint-Petersburg, Russia, 198260
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Coronel Suarez, Buenos Aires, Argentina
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chatsworth, KwaZulu- Natal, South Africa, 4092
Status
Study Complete
Location
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14469
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Northridge, California, United States, 91324
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T5A 4L8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Dorsten, Nordrhein-Westfalen, Germany, 46282
Status
Study Complete
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 2X2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50823
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Doncaster, United Kingdom, DN9 1EP
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92109
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, 4000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sheffield, United Kingdom, S10 2RX
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ohsweken, Ontario, Canada, N0A 1M0
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Meyerspark, Gauteng, South Africa, 0184
Status
Study Complete
Location
GSK Investigational Site
Temuco, Región De La Araucania, Chile
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Temple, Texas, United States, 76508
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mestec Kralove, Czech Republic, 289 03
Status
Study Complete
Location
GSK Investigational Site
Oschatz, Sachsen, Germany, 04758
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90822
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80809
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winsen/Lohe, Niedersachsen, Germany, 21423
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63106
Status
Study Complete
Location
GSK Investigational Site
Winnipeg, Manitoba, Canada, R2V 4W3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45329
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Status
Study Complete
Location
GSK Investigational Site
Guadalajara, Jalisco, Mexico, CP 44340
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1405
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kalispell, Montana, United States, 59901
Status
Study Complete
Location
GSK Investigational Site
Haverhill, Massachusetts, United States, 1830
Status
Study Complete
Location
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bloemfontein, South Africa, 9301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, United Kingdom, M13 9Wl
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schoenebeck, Sachsen-Anhalt, Germany, 39218
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neunkirchen, Saarland, Germany, 66539
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Zerbst, Sachsen-Anhalt, Germany, 39261
Status
Study Complete
Location
GSK Investigational Site
Angermuende, Brandenburg, Germany, 16278
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Harrogate, United Kingdom, HG1 5JP
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pocatella, Idaho, United States, 83209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Milano (Milan), Lombardia, Italy, 20132
Status
Study Complete
Location
GSK Investigational Site
Elsterwerda, Brandenburg, Germany, 04910
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ingelheim, Rheinland-Pfalz, Germany, 55218
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2010-22-11
Actual study completion date
2010-22-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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