For decades, studies have conclusively demonstrated that early intensive insulin therapy administered to newly-diagnosed Type 2 diabetes patients can result in remission of the disease. One meta-analysis report, conducted more than a decade ago and involving over 3,000 patients, demonstrated results of nearly 50% of patients who underwent early intensive insulin therapy achieving drug-free remission for up to two years. Clinical data has also demonstrated that early intensive insulin therapy has resulted in a significant reduction of insulin resistance, a common precursor of Type 2 diabetes.
In a clinical study by Model Clinical Research LLC, Baltimore MD, in collaboration with MannKind Corporation, investigators are seeking to demonstrate that the addition of mealtime Afrezza (aka Technosphere Insulin) can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.
The trial protocol instructs patients to follow a weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm.
In spite of growing clinical evidence that early initiation of insulin therapy has repeatedly demonstrated significant results, including complete remission of the disease, the American Diabetes Association still has insulin therapy as the last step in its Diabetes Standards of Care.
In early stages of Type 2 diabetes, insulin resistance and other factors often causes the pancreas to become over-stressed and unable to keep up with the body's demand for insulin. In layman's terms, the beta cells in the pancreas begin to wear out. Critics of the ADA and the AACE are becoming increasingly vocal in their dissent against the recommendation within the ADA's Standard of Care which advocates early treatment of diabetes with oral medications, such as Metformin, stating that Metformin does nothing to assist the pancreas or improve its ability to produce sufficient levels of insulin. Early intensive insulin therapy, on the other hand, can provide a respite to the over-stressed pancreas by providing much-needed insulin and enabling the pancreas to recuperated and generate new insulin-producing beta cells at a rate that will meet the body's demand while, at the same time, lowering insulin resistance.
Recently, the American Diabetes Association announced changes that would enable the organization to more rapidly response to scientific discoveries for the treatment of diabetes, stating in a press release that, "Beginning with the 2018 ADA Standards of Medical Care in Diabetes, the Standards document will be a “living” document where notable updates are incorporated into the Standards, as determined appropriate by the Professional Practice Committee, noting that their decades-long practice of annually reviewing medical advances would be replaced with more frequent updates, what they described as a "living" Standards of Care, in response to important events such as "new treatments with the potential to impact patient care" and publication of new findings "that support a change to a recommendation and/or evidence level of a recommendation".
Many critics of the ADA are advocating that there is now more than sufficient clinical evidence to meet the ADA's criteria to update its Standard of Care to move short-term intensive insulin therapy to the first step in treating early diabetes. It's hard to argue with results and the incredible potential of this therapy, its puzzling why the ADA has taken so long to advocate early short-term insulin therapy as a first step in combatting this disease. I know of no other treatment that has the potential of remission of diabetes for 50% of treated patients.
Delaying this therapy may result in continuous deterioration of the pancreas to the point where it is no longer repairable and sentences the patient to a difficult life of continuously fighting diabetes. It's a fight that can be won with a 1st Round knockout. It's time for the American Diabetes Association and the American Association of Clinical Endocrinologists to recognize this important treatment and to put it in its proper place in the 2019 ADA Standards of Medical Care in Diabetes.
The clinical trial, entitled "Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients" is scheduled to be completed in September 2018.
Trial Link: clinicaltrials.gov/ct2/show/NCT03324776?term=mannkind&recrs=abdfg&rank=3
