IR2Dx has extensive clinical data on its markers in pharmaceutical drug interventional trials, covering the major classes of anti-diabetic drugs. These studies were performed across a wide range of individual companies’ drugs in a number of settings ranging from pre-diabetic patients, to advanced disease in Type 2 diabetes patients, with end stage renal disease.
These trials were conducted under current good clinical practices (cGCP) with informed consent. The outcomes were published in prestigious peer-reviewed journals. The total number of trials is over 30, with new published studies each year adding to our extensive trial database of 42 publications. Please see our clinical studies in Publications & Abstracts.
Type 2 Diabetes Patients
In the clinical studies, over 14,000 patients ranging from pilot trials of a few patients to more than 4,000 patients have been studied in Type 2 diabetic drug response trials. Not all of the markers incorporated in our products are included in each and every study. The markers were selected from the clinical studies to use the minimal number of markers to optimally represent the most important different mechanisms leading to Type 2 diabetes.
The largest percentage of our trial data is in the area of drug comparison studies. Patients on first line therapy with either metformin or sulfonylureas were compared with similar patients using sensitizers such as pioglitazone, or newer compounds like GLP-1 analogs or DPP-4 inhibitors.
The trials showed that our biomarkers generally demonstrated good concordance with traditional glucose-related markers like fasting plasma glucose (FPG) or HbA1c. The disadvantages of the glucose markers were twofold. First, they were much slower to detect disease deterioration as demonstrated by our overall group of markers and secondly, they were much slower to demonstrate improvement with a change in therapeutic regimen. In many cases when the glucose related tests indicated that patients were under relatively good control, in fact their underlying metabolic markers were very abnormal.
In contrast, our markers collectively demonstrated positive changes – in as little time as a week. The markers will be used with traditional glucose-related markers to provide optimum personalized management of Type 2 diabetes.
Pre-Diabetic Patients with Insulin Resistance
The objective for a prediabetes patient is early detection followed by therapy to delay or avert diabetes and its associated conditions. This should take place before the disease has progressed and may be diagnosed through traditional means, such as fasting plasma glucose, oral glucose tolerance testing, or HbA1c.
We have studied just under 1,500 patients who have not been diagnosed with diabetes, in diabetes drug interventional trials with lower dose diabetes medications, with and in comparison with either lipid lowering drugs or diet and exercise alone. In each case, the IR2Dx markers demonstrated the additive value of assessing response to low dose diabetes medications used to reduce risk of disease, monitored by normalizing levels of our markers.
Future Clinical Trials with Opportunity to Participate as a Clinical Site
IR2Dx intends to develop additional clinical data by using the IR2Dx TIGAR™ markers to screen, and then monitor, high risk patients on a regular basis. This is a major opportunity for IR2Dx to assist government healthcare payers, employers and third party insurers, in reducing costs and obtaining better patient outcomes.
IR2Dx plans to augment its extensive clinical database with clinical outcome studies in both of the disease settings described above. These major trials will be conducted under (cGCP). Our web site will post information as to when these trials will be open to clinician/laboratory participation and later, patient enrollment under enrollment criteria. Find out more about Partnership Opportunities.