Diabetes is a chronic disease that affects how your body uses blood sugar, with hyperglycemia being the major hallmark of the disease. The underlying cause of diabetes varies by type (type 1 or type 2). Type 1 diabetes (T1D) is an autoimmune disease that permanently destroys β-cells of the pancreatic islet, which means that the body can no longer produce insulin. Type 2 diabetes (T2D) is characterised by insulin resistance and pancreatic β-cell failure, with an underlying genetic predisposition that is heavily influenced by diet and lifestyle. Regardless of the diabetes type, the disease can lead to serious complications such as diabetic foot ulcers, diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, and cardiovascular (CV) disease. Significant advances in diabetes medicine, such as anti-diabetic oral medications, incretin therapies, and novel insulin formulations, have been made over the past century, but many unmet needs remain for this complex and difficult-to-treat disease.

The need for additional treatments that provide both glycemic and non-glycemic benefits is applicable to both types of diabetes, especially since the control of diabetes comorbidities is less than optimal in most patients. Incretin-based therapies are partially addressing this need in T2D, with glucagon-like peptide-1 receptor agonists (GLP-1RAs) inducing weight loss, lowering blood pressure, and providing CV benefits. Sodium glucose cotransporter inhibitors (SGLTIs) are also providing these non-glycemic benefits in T2D patients. Because of this, SGLTIs such as Sanofi’s/Lexicon’s Zynquista (sotagliflozin), AstraZeneca’s Forxiga (dapagliflozin), Astella’s Suglat (ipragliflozin), and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) are being increasingly investigated in T1D patients and are on track to becoming approved and marketed in the near future.

Reducing the occurrence of hypoglycemia, or low blood sugar levels, in insulin-dependent diabetic patients is another vital area in the diabetes space that requires ongoing attention. Hypoglycemia is one of the top safety concerns associated with diabetics who are taking insulin. In severe cases, it can cause a coma or be fatal. Currently, all available insulin therapies are associated with the risk of hypoglycemia, despite the fact that new generation insulins such as Novo Nordisk’s Tresiba (insulin degludec) have lowered the risk. GlobalData believes that transformational insulin products are necessary to combat the risk of hypoglycemia in insulin-dependent patients. Fortunately, a novel advancement in insulin technology, known as glucose-responsive insulin or “smart” insulin, could potentially fill this gap. Although this novel insulin technology has yet to enter clinical trials, it remains promising, as the insulin would be able to detect glucose levels and be activated or deactivated depending on whether blood sugar levels are high or low, respectively.

The issue of significantly decreased compliance among patients using injectable therapies (such as insulin and GLP-1RAs) continues to be partially addressed by drug developers. Most attempts to bring commercially successful non-injectable insulin to market have been met with failure, as seen with Pfizer’s Exubera (insulin human). Currently, only one inhalable insulin is marketed in the US: Mannkind’s Afrezza (technosphere insulin). However, despite the fact that Afrezza has the potential to increase patient compliance, the product has stumbled as a result of reimbursement issues, safety issues, and physician concerns. On the other hand, the GLP-1RAs are undergoing incredible progress, with once weekly injectable versions such as Eli Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Ozempic (semaglutide) becoming available on the market. In addition, Novo Nordisk’s NN-9924, which is in Phase III clinical trials, is poised to become the first oral GLP-1RA on the market.

The most pressing unmet need in the diabetes space is the development of breakthrough treatments that address the underlying cause of the disease. In T1D, this would be a treatment that would interfere with either the etiology or the pathogenic processes involved in the eradication of the β-cells. In T2D, the treatment would have to effectively target the root of the disease, insulin resistance. Key opinion leaders interviewed by GlobalData believe that opportunities may lie in regenerative medicine, but unfortunately most stem cell therapies targeting diabetes are still in very early stages of development. Whether or not a truly curative treatment will be discovered and developed is yet to be seen. In the meantime, developers continue to focus on tackling the multiple unmet needs that remain in this space.

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By GlobalData