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Thiazolidinedione
Rosiglitazone for Prediabetes-Related Coronary Artery Disease
Phase 4
Waitlist Available
Research Sponsored by Denver Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Persons with angina or any other cardiac or pulmonary symptoms that would potentially limit exercise performance will be excluded.
Women using hormone contraception or on hormone replacement therapy will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will study the effects of rosiglitazone on exercise tolerance, coronary artery calcification, and diabetes indicators in subjects with impaired glucose tolerance.
Who is the study for?
Adults aged 25-75 with prediabetes, specifically impaired glucose tolerance but not yet diabetic (FPG <126 mg/dL, HbA1c <6.5%), and a BMI of 25-40 can join this trial. Women must be non-pregnant, postmenopausal or using barrier contraception. Exclusions include severe liver disease, hypersensitivity to thiazolidinediones, chronic steroid use, recent weight loss programs or intensive exercise initiation.
What is being tested?
The study is testing if rosiglitazone can prevent coronary artery disease in people with impaired glucose tolerance over an 18-month period compared to a placebo. Participants will undergo tests for exercise tolerance and heart health at the start, after one year and at the end of the study.
What are the potential side effects?
Rosiglitazone may cause side effects like fluid retention leading to swelling and weight gain; it could also increase risk for heart problems or worsen existing diabetes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have heart or lung conditions that limit my ability to exercise.
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I am not using hormone-based birth control or hormone replacement therapy.
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My liver function tests are within normal limits.
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I cannot take rosiglitazone due to health reasons.
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I have severe heart pain or discomfort that needs constant medication.
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I have had cancer before, but not skin cancer.
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I have severe heart failure or high blood pressure needing medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2008 Phase 3 trial • 1791 Patients • NCT0003248755%
Musculoskeletal
43%
Infections
35%
General Disorders
35%
Nervous system
32%
Gastrointestinal Disorders
26%
Injury
25%
Respiratory
24%
Skin
21%
Eye Disorders
19%
Investigations
19%
Psychiatric
15%
Renal
13%
Metabolism
13%
Vascular
9%
Infections and infestations
9%
Surgical
9%
Neoplasms
9%
Reproductive
8%
Cardiac Disorders
7%
Blood
7%
Ear
7%
Immune
4%
Cardiac disorders
4%
Gastrointestinal disorders
4%
Surgical and Medical Procedures
3%
Renal and Urinary Disorders
3%
Respiratory, thoracic and mediastinal Disorders
3%
Nervous System Disorders
3%
Neoplasms benign, malignant and unspecified
3%
Metabolism and Nutrition Disorders
3%
Injury, poisoning and procedural complications
2%
Musculoskeletal and connective tissue disorders
2%
Vascular Disorders
2%
Psychiatric Disorders
1%
Hepatobiliary Disorders
1%
Blood and lymphatic Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 2
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Rosiglitazone
Group II: 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosiglitazone
FDA approved
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,747 Total Patients Enrolled
Denver Research InstituteLead Sponsor
3 Previous Clinical Trials
567 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood sugar levels after eating are between 140-199 mg/dL.Your blood sugar levels must be below 126 mg/dL, C-peptide level should be above 2.0 ng/mL, and HbA1c should be less than 6.5%.You have been regularly drinking too much alcohol or using drugs in the past 6 months.I do not have heart or lung conditions that limit my ability to exercise.I take steroids for a chronic condition.I am not on any weight loss medications or programs, nor have I started an intensive exercise program recently.I am not using hormone-based birth control or hormone replacement therapy.I am using effective birth control and will continue for the study duration and 30 days after.I am a woman who can have children and my pregnancy test is negative.I don't have any health issues that would make it unsafe for me to join the study.You have had a strong allergic reaction to thiazolidinediones, like trouble swallowing, breathing, fast heartbeat, or skin problems.You must have a body mass index between 25 and 40, and weigh less than 300 pounds.My liver function tests are within normal limits.I am a woman who is either postmenopausal, surgically sterile, or using effective birth control.I cannot take rosiglitazone due to health reasons.I have severe heart pain or discomfort that needs constant medication.I have had cancer before, but not skin cancer.You are currently smoking.I am between 25 and 75 years old.I have severe heart failure or high blood pressure needing medication.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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