Last updated: 11/07/2018 04:16:03
Thiazolidinedione Intervention with vitamin D EvaluationTIDE
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
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:
Drug: pioglitazone
Drug: rosiglitazone
Drug: placebo
Dietary supplement: Vitamin D
Dietary supplement: Placebo
Enrollment:
1332
Observational study model:
Not applicable
Primary completion date:
2010-22-11
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
Mumbai, India, 400007
1.3 miles (2.1 km) away from your location
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pune, India, 411004
72.4 miles (115.8 km) away from your location
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nasik, India, 422013
93.7 miles (149.9 km) away from your location
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
Terminated (halted prematurely)
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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