News to Muse - May 2013
Once-a-Week Insulin under Study
AntriaBio has developed a formulation of insulin that is designed to release insulin slowly and uniformly over a period of seven days. AB101 is a once-a-week injectable basal insulin. Researchers take PEGylated insulin and then encapsulate it into a poly-lactic, poly-glycolic microsphere. After injection, the PEGylated insulin is slowly released at the injection site as the polymer microspheres are broken down by simple hydrolysis. PEGylation is a process used to modify the pharmacological properties of a drug—in this case to slow down the absorption process.
Early Control of High Blood Pressure Benefits Those with Type 2 Diabetes
A large study of over 15,000 individuals found that those patients who received aggressive efforts to control elevated blood pressure within the first year of diagnosis, experienced lower rates of major cardiovascular events and heart attack. Blood pressure levels should be below 140/90.
Link between Type 1 Diabetes, Celiac Disease, and Diabetic Retinopathy over Time
The Swedish National Patient Registry tracked 41,566 patients with Type 1 diabetes between 1964–2009. Within this registry they looked at individuals who had Type 1 diabetes and celiac disease. Researchers wanted to assess the long-term complications of individuals with both conditions. In reviewing the data, it was apparent there was an increased risk of diabetic retinopathy. Although the risk was low for their first five years from diagnosis, there was a neutral risk at 5-10 years from diagnosis, an increased risk was noted at 5-10 years, and a three-fold risk occurred after 15 years. Speculation as to why the lower risk in the early years is related to the lower rates of cholesterol, high blood pressure and A1C. Over time, it is thought that a low-grade inflammatory process may occur. Therefore, it is important for those individuals with diabetes and celiac disease to be attentive in obtaining a yearly eye exam.
Ultra-long-acting Insulin and Pre-mixed Ultra-long-acting Insulin with Novolog Recommended for Approval
An FDA advisory panel has recommended approval of Novo Nordisk’s ultra-long-acting basal insulin degludec (Tresiba), and their pre-mixed combination insulin 70% degludec and 30% rapid-acting aspart (Novolog), which will be marketed as Ryzokeg.
The ultra-long-acting insulin is taken once a day but may be delayed from 8-40 hours after the last dose. Trials have shown less nocturnal hypoglycemia and a flatter profile. Because of a possible increase in cardiovascular risk the FDA panel is recommending a 5-year followup study to evaluate cardiac risk. The panel is not recommending holding up approval, but rather allowing the study to be started after approval.
Insulin in Clinical Trials
Novo Nordisk is Set to Begin Phase 3 Clinical Trials on Ultra-rapid-acting Insulin – FIAsp
FIAsp would impact mealtime blood glucose readings as it is more similar to the immediate response of insulin experienced by those without diabetes. This would be more convenient—as a 15-minute waiting period would not be necessary, individuals would have a decreased risk of hypoglycemia and potentially less weight gain. If blood glucose levels decreased more rapidly, individuals would be less likely to stack insulin and experience delayed hypoglycemic reactions.
Mannkind has an ultra-rapid-acting inhaled insulin—Afrenza, which is scheduled to be submitted for approval in late 2013. Other companies are attempting to produce a faster-acting insulin by adding an enzyme that would degrade connective tissue—allowing insulin to be absorbed more quickly.
Disposable Insulin Delivery Devices
Disposable Insulin Delivery Device for Basal and Bolus Insulin Available for Patients with Type 2 Diabetes
Valerita’s V-Go Disposable Insulin Delivery Device
A clinical trial using the V-Go disposable insulin delivery device found that after 12 weeks, A1C levels dropped on average 1.2%. The V-Go disposable insulin delivery device delivers a pre-set dose of basal insulin over 14 hours and 2-unit bolus insulin using a 2-step process. The device may be used instead of a vial, syringe, pen, or insulin pump. The device, which requires daily changes, is targeted to individuals with Type 2 diabetes. The V-Go is available in three preset rates of 20, 30 or 40 units of basal insulin per day, and each version allows an additional 36 units of bolusing in 2-unit increments—up to 18 units per day. The device is 2.4” x 1.3” x 0.5” and is inserted using 30-gauge stainless steel needles. The mechanical dosing can be done through clothing—making it easy to use. Users gave it a positive review of 9.1 out of a score of 10.