|
Home
Search
Study Topics
Glossary
|
| Study 1 of 1 for search of: | Thiazolidinediones Intervention with Vitamin D Evaluation |
|
Previous Study | Return to Search Results | Next Study |
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
Inclusion Criteria:
Age ≥ 50 years and evidence of vascular disease defined as ≥1of:
Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of:
history of treated or untreated hypertension with left ventricular hypertrophy by electrocardiogram (ECG) or echocardiogram
Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| 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 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| 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 |
|
Cardiovascular Outcomes Academic Research Collaborator: Population Health Research Institute / Hamilton Health Sciences / McMaster University / Ontario Canada |
|
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 |