CLINICAL TRIAL

Clopidogrel for Diabetes Mellitus

Recruiting · 18+ · All Sexes · Jacksonville, FL

This study is evaluating whether clopidogrel may have different effects in patients with diabetes and chronic kidney disease.

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About the trial for Diabetes Mellitus

Eligible Conditions
Kidney Diseases · Chronic Kidney Disease (CKD) · Type 2 Diabetes Mellitus · Diabetes Mellitus · Myocardial Ischemia · Renal Insufficiency, Chronic · Coronary Disease · Coronary Artery Disease · Coronary Artery Disease (CAD) · Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 2 different treatments. Clopidogrel is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Clopidogrel
DRUG
Clopidogrel active metabolite
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Clopidogrel
DRUG
Clopidogrel active metabolite
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clopidogrel
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Diabetes Mellitus or one of the other 9 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Odds of Eligibility
High>50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 hours.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Clopidogrel will improve 1 secondary outcome and 2 other outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 6 hours.

P2Y12 reaction units (PRU)
6 HOURS
Comparison of platelet reactivity measured as PRU assessed by VerifyNow after a 600 mg clopidogrel LD between DM patients with and without CKD
Clopidogrel active metabolite concentration
6 HOURS
Comparison of clopidogrel active metabolite plasma concentrations, Tmax, Cmax and AUC
Platelet reactivity index (PRI)
BASELINE
Comparison of of platelet reactivity measured as PRI assessed by VASP after incubation with clopidogrel active metabolite between DM patients with and without CKD

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can diabetes mellitus be cured?

Diabetes is a chronic condition. Since many of the symptoms of diabetes mellitus are reversible, many people can control their blood sugar adequately with proper nutrition and regular exercise.

Anonymous Patient Answer

What causes diabetes mellitus?

Diabetes is probably a family trait. There is no evidence for environmental triggers in development of the disease. It may, however, be modulated by genetics.

Anonymous Patient Answer

What is diabetes mellitus?

Diabetes has its roots in a progressive deterioration of the functions of many body organs including the brain. Diabetes is the underlying cause for many neuropathic and ischemic complications of vascular disease, which leads to the deterioration of one's own brain.

Anonymous Patient Answer

What are common treatments for diabetes mellitus?

Most patients with diabetes are treated for their condition; however, there are also other treatments that are typically implemented in diabetics. Some of these include, but are not limited to, antihypertensive medications, oral medication for hypertension and insulin, and oral medication for controlling glucose levels or lowering cholesterol in diabetics.

Anonymous Patient Answer

What are the signs of diabetes mellitus?

Symptoms of diabetes mellitus include frequent urination, excessive thirst, fatigue and headaches. In addition there is a loss of skin sensation and increased skin pigmentation. A person with diabetes mellitus may not realize the significance of these symptoms. Diabetes can be prevented and managed by regular screening and the detection of early signs of disease.

Anonymous Patient Answer

How many people get diabetes mellitus a year in the United States?

Diabetes was fairly common in US adults. More than one-third (36.0%) of US adults received a diabetes diagnosis in the 12-month or prior period, and about one in four (23.6%) had been diagnosed in the past 6 months. Women and Latinos had higher prevalence of diabetes in comparison to Caucasians (17.4% vs. 10.2%, respectively). Among adults with diabetes, the most common treatment regimen (monotherapy) was metformin (51.0%), and combination medication was the second most common regimen (37.8%).

Anonymous Patient Answer

How does clopidogrel work?

Although clopidogrel is an antiplatelet drug, it also acts directly on thrombin to prevent clot formation in the arterial system. This mechanism seems to be associated with how clopidogrel reduces the risk of thromboembolism when used during pregnancy and in patients who undergo surgery. Clopidogrel may also be an effective anticoagulant during treatment of type 2 diabetes.

Anonymous Patient Answer

Who should consider clinical trials for diabetes mellitus?

Trial eligibility based on age and HbA1c was more accurate than clinical assessment for the presence of diabetes and was associated with greater treatment intensity. Thus, this clinical assessment, while helpful to identify potential trial candidates, was not as reliable or accurate as trial eligibility. Trial eligibility as an indication for potential participation increased treatment intensity both by identifying individuals who would benefit from a trial and by identifying individuals who were undertreated.

Anonymous Patient Answer

Have there been other clinical trials involving clopidogrel?

The present study demonstrated that patients on dual antiplatelet treatment with two or more clopidogrel-containing agents are more likely to suffer a myocardial infarction than patients receiving an anticoagulant with a nonanatomic chemical in a similar category as clopidogrel; therefore, care must be taken when performing cardiac and cerebrovascular imaging with these combinations of antiplatelet therapies.

Anonymous Patient Answer

Have there been any new discoveries for treating diabetes mellitus?

A number of new drug approaches have been invented that have the potential to have an all new role in the treatment of the diabetes mellitus. Although most of them are in the early phases of clinical trials it is hoped that new medicines may be available sooner or later in more forms of treating the diseases to the diabetic patients in the near future.

Anonymous Patient Answer

Is clopidogrel safe for people?

Clopidogrel and aspirin appear to be potentially interchangeable in people, at least in the short term after PCI. If, after 2 years, you have high on-treatment platelet reactivity (HTPR), further data are needed to determine whether clopidogrel, with the possibility of being an alternative, could be useful.

Anonymous Patient Answer

How serious can diabetes mellitus be?

The diabetes-specific mortality risk is increased in all persons with diabetes compared with non-diabetes, but with a stronger association in persons with the more severe disease. This disparity is partly attributed to differences in comorbidity between the two cohorts.

Anonymous Patient Answer
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