Clinical trial NCT00879970: Thiazolidinedione Intervention With Vitamin D Evaluation
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Cardiovascular Outcomes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Population Health Research Institute
First posted: 2009-04-13
Enrollment: 1332
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 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


Eligibility 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

Primary outcomes:
measure: 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)
measure: 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:
measure: Number of Participants With Any Revascularization
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: Number of Participants With Need for Hospitalization for Any Reason
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: 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)
measure: Number of Participants With Composite Microvascular Outcome
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: 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)
measure: 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)
measure: Number of Participants With Clinical Proteinuria
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: Number of Participants With a Fracture
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: 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)
measure: 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)
measure: Number of Participants With Erectile Dysfunction
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: Mean Score on Euro-QoL (EQ)-5D
timeFrame: From Randomization at Visit 3 to Final Visit (up to 162 days)
measure: 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)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Northridge
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
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state: California
city: Decatur
country: United States
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state: Georgia
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country: United States
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state: Georgia
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state: Idaho
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city: Ciudad Autonoma de Buenos Aires
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state: Buenos Aires
city: Coronel Suarez
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state: Región De La Araucania
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state: Región Metro De Santiago
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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state: Brandenburg
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state: Niedersachsen
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state: Nordrhein-Westfalen
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state: Rheinland-Pfalz
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facility: GSK Investigational Site
state: Rheinland-Pfalz
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country: Germany
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city: Berlin
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city: Hamburg
country: Germany
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city: Ahmedabad
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city: Bangalore
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Italy
facility: GSK Investigational Site
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country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St Pertersburg
country: Russian Federation
facility: GSK Investigational Site
city: St Petersberg
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Syktyvkar
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Vladivostok
country: Russian Federation
facility: GSK Investigational Site
city: Vladivostok
country: Russian Federation
facility: GSK Investigational Site
city: Volgograd
country: Russian Federation
facility: GSK Investigational Site
city: Voronezh
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Meyerspark
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Parktown
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Chatsworth
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Umhlanga Rocks
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Benoni
country: South Africa
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Newton
country: South Africa
facility: GSK Investigational Site
city: Observatory
country: South Africa
facility: GSK Investigational Site
city: Parktown
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Worcester
country: South Africa
facility: GSK Investigational Site
city: Eksjö
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Härnösand
country: Sweden
facility: GSK Investigational Site
city: Karlshamn
country: Sweden
facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
city: Ljungby
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Oskarshamn
country: Sweden
facility: GSK Investigational Site
city: Skene
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Vällingby
country: Sweden
facility: GSK Investigational Site
city: Växjö
country: Sweden
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Chippenham
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
country: United Kingdom
facility: GSK Investigational Site
city: Harrogate
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.