In this three part series on diabetic clinical trials we will look at what the current diabetic clinical trials are focused on, what to know before participating in one, and the risks and rewards of participating in clinical trials for diabetes.
What Are Clinical Trials?
Before any new treatment for any disease or condition can be made available to the general public, it must be tested and proven both safe and effective in rigorously controlled clinical trials using protocols and documenting test results. Participation by patients is strictly voluntary and they may withdraw from it at any time, for any reason.
In the area of diabetes research much of the clinical trial activity draws on strategies for improving diabetes care through new investigational medications along with improved mechanisms for delivering the multiple medications that diabetics must take in order to maintain optimum glycemic control.
For type II diabetics, there are several treatment options available with already approved medications. Initial treatment with oral medications often occurs if the target A1C level is not achieved within 3 months of dietary and lifestyle changes. Generally, metformin is the first oral medication given to a patient. If after another 3 months of single therapy with metformin is not successful, then a number of combinations with newer oral hypoglycemics are available.
Six possible treatment options can be considered with metformin:
- Sulfonylureas,
- TZDs (Thiazolidinedione),
- DPP-4-inhibitors,
- SGLT2 inhibitors,
- GLP-1 receptor agonists, or
- basal insulin with or without fast acting insulins.
Newer 'groups' of investigational medications are now in clinical research trials to add to this widening array of choices as well. In addition, easier modalities of administration of the GLP-1 receptor agonists and DPP-4 inhibitors, such as once-a-week or once-a-month injections/ingestion are underway.
Potentially more effective insulin products combined with GLP-1 receptor agonists are also being studied at this time by many clinical investigators including those at Chase Medical Resesarch, LLC. These have shown great promise for blood glucose control with potential weight loss.
Regulatory bodies such as the Food and Drug Administration (FDA) only approve new treatments for general use after the results of the clinical trials have been verified. Although there may be exciting medical breakthroughs during the trials, the public generally doesn't learn of the new investigational medication options till the approval by the FDA has occurred. For diabetics interested in new alternatives, participating in a clinical trial may be considered an option.
Most clinical trials are conducted as double-blind studies, meaning neither the patient nor the physician knows which treatment the volunteer will receive, the one being investigated or one with known benefits or characteristics. Once the trial period has concluded, researchers then compare the results of the two groups – those who did receive the new therapy and those who did not – to identify the benefits and side-effects, if any, of those treatments.
In part two of our three part series, we will look at things to know before participating in a diabetes clinical trial.
Learn More About Chase Medical Research
At Chase Medical Research, we currently have a number of diabetic clinical trials that we are now enrolling diabetic subjects that meet the qualification criteria.We are investigating very exciting and innovative therapies that may have a profound effect on diabetes care in the near future.
Study related medication and treatments are provided at no-cost, and there is often compensation for time and travel. If you're interested in seeing if you qualify for a diabetes clinical trial, click the button below.
Don't hesitate to contact us if you have any questions!
