Study 1 of 1 for search of: Thiazolidinediones Intervention with Vitamin D Evaluation
Previous Study Return to Search Results Next Study

Full Text View
Tabular View
No Study Results Posted
Related Studies
Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)
This study is currently recruiting participants.
Verified by GlaxoSmithKline, November 2009
First Received: April 2, 2009   Last Updated: November 19, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00879970
  Purpose

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


Condition Intervention Phase
Cardiovascular Disease
Type 2 Diabetes Mellitus
Drug: pioglitazone
Drug: placebo
Dietary Supplement: vitamin D
Dietary Supplement: placebo
Drug: rosiglitazone
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The composite primary outcome for the vitamin D research question is death or serious cancer requiring hospitalization, chemotherapy or surgery. [ Time Frame: up to 10 years ] [ Designated as safety issue: Yes ]
  • The composite cardiovascular primary outcome for the TZD research questions is the first occurrence of either: a) cardiovascular death; b) nonfatal myocardial infarction (MI); or c) nonfatal stroke. [ Time Frame: Approximately 5.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality, a composite microvascular outcome, hospitalization for heart failure, revascularization, angina, cancer and fracture [ Time Frame: Approximately 5.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16000
Study Start Date: May 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TZD placebo: Placebo Comparator Drug: placebo
thiazolidinedione factor intervention
vitamin D placebo: Placebo Comparator Dietary Supplement: placebo
Vitamin D factor intervention
pioglitazone: Active Comparator Drug: pioglitazone
thiazolidinedione factor intervention
rosiglitazone: Active Comparator Drug: rosiglitazone
thiazolidinedione factor intervention
vitamin D: Active Comparator Dietary Supplement: vitamin D
vitamin D factor intervention

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879970

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
United States, Georgia
GSK Investigational Site Recruiting
Tucker, Georgia, United States, 30084
Principal Investigator: Joshua Barzilay            
United States, Montana
GSK Investigational Site Recruiting
Kalispell, Montana, United States, 59901
Principal Investigator: Eve Gillespie            
United States, New York
GSK Investigational Site Recruiting
Westfield, New York, United States, 14787
Principal Investigator: Donald Brautigam            
United States, Tennessee
GSK Investigational Site Recruiting
Kingsport, Tennessee, United States, 37660
Principal Investigator: Judith White            
United States, Texas
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Priscilla A Hollander            
Canada
GSK Investigational Site Recruiting
Hamilton, Canada, L8N 3X5
Principal Investigator: Omid Salehian            
GSK Investigational Site Recruiting
Halifax, Canada, B3H 2Y9
Principal Investigator: Thomas Ransom            
Canada, British Columbia
GSK Investigational Site Recruiting
Chilliwack, British Columbia, Canada, V2P 4M9
Principal Investigator: Kay Ho            
Canada, Manitoba
GSK Investigational Site Recruiting
Winnipeg, Manitoba, Canada, R2H 0R8
Principal Investigator: Pravinsagar G Mehta            
GSK Investigational Site Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Principal Investigator: Vincent Woo            
Canada, Ontario
GSK Investigational Site Recruiting
Etobicoke, Ontario, Canada, M9R 4E1
Principal Investigator: Hasnain Khandwala            
GSK Investigational Site Recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Irene Hramiak            
GSK Investigational Site Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Eva Lonn            
GSK Investigational Site Recruiting
Oshawa, Ontario, Canada, L1J 2K1
Principal Investigator: James Cha            
GSK Investigational Site Recruiting
Brampton, Ontario, Canada, L6Z 4N5
Principal Investigator: Milan Gupta            
GSK Investigational Site Recruiting
Mississauga, Ontario, Canada, L5M 2V8
Principal Investigator: Irving Gottesman            
GSK Investigational Site Recruiting
Oakville, Ontario, Canada, L6H 3P1
Principal Investigator: Yaw D Twum-Barima            
GSK Investigational Site Recruiting
Thornhill, Ontario, Canada, L4J 8L7
Principal Investigator: Ronald M Goldenberg            
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M4R 2G4
Principal Investigator: Ronnie Aronson            
GSK Investigational Site Recruiting
Barrie, Ontario, Canada, L4M 7G1
Principal Investigator: Suzan Abdel-Salam            
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1C 1S6
Principal Investigator: Kim Tan            
Canada, Quebec
GSK Investigational Site Recruiting
Laval, Quebec, Canada, H7T 2P5
Principal Investigator: Andre Belanger            
GSK Investigational Site Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Principal Investigator: Paul Poirier            
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111960
Study First Received: April 2, 2009
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00879970     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Cardiovascular Outcomes
Academic Research Collaborator: Population Health Research Institute / Hamilton Health Sciences / McMaster University / Ontario Canada

Additional relevant MeSH terms:
Ergocalciferols
Vitamin D
2,4-thiazolidinedione
Vitamins
Metabolic Diseases
Pioglitazone
Growth Substances
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Micronutrients
Glucose Metabolism Disorders
Rosiglitazone

ClinicalTrials.gov processed this record on November 20, 2009