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Thiazolidinedione Intervention With Vitamin D Evaluation | Clinical Trials | Clareo Health

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Thiazolidinedione Intervention With Vitamin D Evaluation

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

NCT00879970•GlaxoSmithKline

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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
+12 more criteria

Locations (331)

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Tucker, Georgia, United States

GSK Investigational Site

Pocatella, Idaho, United States

GSK Investigational Site

Pocatello, Idaho, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Haverhill, Massachusetts, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

April 18, 2017

Enrollment

1,332

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

pioglitazone

DRUG

rosiglitazone

DRUG

placebo

DRUG

Vitamin D

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Thiazolidinedione Intervention With Vitamin D Evaluation

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)