Research and development for potential COVID vaccines and treatments has been at the forefront of the pharmaceutical industry for most of 2020. Because of this, research dedicated to other therapeutic areas may be affected.

In recognition of World Diabetes Day, we asked our experts, Steven Lobel, PhD, D-ABMLI, MBA, FACB, Clinical Immunology and Pediatrics/Endocrinology, and Lisa Wetherington, Senior Project Manager, to talk about the growing focus with COVID-19 research and how this poses a threat to the dedicated research for diabetes cures and treatments. They also address the many ways Q² Solutions partners with sponsors to help bring new diabetes drugs to market.

What risks do you see to dedicated diabetes research in light of COVID-19?

Steven:
I see several possible issues, depending on where the research is being performed and at what level. At academic institutes, where most diabetes research is actually performed, allocation of funds may slow for new research as NIH and other federal dollars are moved to support of COVID-19 vaccine and therapeutic development. Additionally, recruitment of new subjects may become difficult due to lock-down and fears of travelling for patients with diabetes, one of the known risk factors for COVID-19 infection. Ongoing studies may be affected by missed appointments as registered research subjects miss their onsite appointments with investigators.

At the pharmaceutical level, similar issues may occur. Pre-clinical studies may be put on hold so that monies may be committed to COVID-19 research and development. Early phase studies may also be put on hold, or recruitment halted or slowed, so that allocated monies may be re-distributed towards COVID-19 work.

Lisa:
Diabetic patients face a higher chance of experiencing serious complications from COVID-19. Due to this risk, some patients might be reluctant to go out into a clinic for study enrollment or study follow up. Therefore, some sponsors have arranged for home visits by a health care professional to collect blood samples, complete electrocardiograms, vital signs, etc.

How have you seen diabetes research advance over the years? And how is Q² Solutions positioned to be a leading partner?

Steven:
Not to age myself, but I’ve seen diabetes research address a: single disease; to early onset diabetes and late onset diabetes; to juvenile diabetes and adult diabetes; to type 1 diabetes(T1DM) due to autoimmune destruction of beta cells and type 2 diabetes (T2DM) due to insulin resistance; to just this past year a new recommendation for the classification of T2DM into 5 categories with a possible progression between them. A greater understanding of the role of the microbiome in T2DM and the understanding of the pharmacology workings of a drug that has been used to treat diabetes for 63 years – metformin.  

These recent breakthroughs in the classification of subtypes of T2DM occurred through the understanding of pathways identified by classic and new biomarkers. The role of the microbiome was elucidated by understanding the metabolism of the amino acid imidazole propionate. And metformin’s major contributor of therapeutic action, the FBP1, may now be a new target in the treatment of T2DM. Q² Solutions Labs, (Central, Bioanalytical, ADME and Genomics) have all played a role in this research by performing the biomarker assay development, biomarker assay clinical testing, metabolic pathway elucidation with genomic tools and microbiome microbiologic analysis.

Lisa:
Some advances in treating adult and pediatric diabetic patients are insulin pumps and continuous blood glucose monitors (CGM). Both have improved care; however, there is a learning curve and further patient education is needed in order to be effective. The results of clinical trials delivered smarter and smaller devices. For Type I diabetes severe hypoglycemia (low blood glucose) is common and with the advances of CGM the device can detect low glucose readings and stop insulin delivery. Thus, preventing loss of consciousness and /or seizures. 

New medications, devices and advancements have also been seen in patients with Type 2 diabetes and insulin resistance issues. Several of these new medications also combat against heart and kidney issues, that many patients face with this disease.

For some clients, Q² Solutions has a dedicated Endocrine/Diabetes Program Lead that can be a good point of contact for the client with any escalations or program level enhancements. The Program Lead is a valuable contact for the sponsor and offers program level metrics for all the client endocrine studies.

How is Q² Solutions supporting sponsors in confronting diabetes as a critical global health issue?

Steven:
Q² Solutions (and our partner laboratory Quest Diagnostics) has been supporting diabetes research, preclinical to post marketing, for over 25 years (previously as Quintiles). We know diabetes and we know how the global increase of this disease will affect peoples lives and the extended requirement to treat them with new and effective medicines and treatment devices. For example, we provide support for the full spectrum of diabetic complications: cardiac and vascular pathology due to systemic inflammation; as well as, renal, retinal and neuropathies due to the interactions of numerous cytokines, chemokines and oxidative stress markers. Our experts partner with pharmaceutical scientists to design and support the best panels of unique biomarkers for the diagnosis and treatment of these underserved complications.

In a normal situation, what do study teams describe as their greatest challenges in diabetes research?

Lisa:
Sometimes enrollment and patients attending their scheduled visits can be an issue. For instance, teenagers or youth might have trouble meeting all the visits requirements with a clinical trial due to school, sports and after school commitments. Some older patients may also have a hard time getting to their appointments, depending on how they’re feeling and their access to transportation.

How has your role as a project manager impacted clinical trials for diabetes patients?

Lisa:
As a project manager, I ensure that our entire team strives to make sure that lab samples are resulted on time. We understand any delays with results to sites can have a significant impact to patient care. For example, patients might have to reschedule clinic visits, their treatments might be delayed, and they might suffer a financial hardship from this. We also ensure that samples are correctly routed to any referral labs for further testing and monitor courier tracking if potential risks arise.
 

Resources

Our lab experience includes testing services in support of clinical trials for insulins, GLP-1/glucagon dual-agonists, SGLT2 inhibitors, DPP-4 inhibitors (gliptins), combination therapies and more. To learn more about our broad range of testing services and capabilities for diabetes studies, see our diabetes factsheet.

To learn more about our laboratory solutions to support global COVID-19 clinical trials, see our SARS-CoV-2/COVID-19 Testing Portfolio.
 

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