Novel Diabetes Devices on the Horizon to Improve Glucose Management

Several novel diabetes management devices and technolgoy advances are approaching FDA review including first of its kind all-in-one patch, a much anticipated insulin capsule, and a shelf-stable glucagon rescue pen for severe hypoglycemia.

For patients with type 2 diabetes (T2D), there has been resistance to initiating insulin from both clinicians and the patients. Glucose management in people with T2D  is a complex process that calls on patient willingness to inject just the right amount of insulin and with only a fraction of the insulin that enters the bloodstream actually reaching the liver so excess blood glucose is stored in muscle and adipose tissue, resulting in undesirable weight gain.

There are two new devices: one now on the market and another getting closer that may address the short-comings of traditional insulin injections, with potential to improve diabetes outcomes for many adults with type 2 diabetes.

And for people with type 1 diabetes, a novel simple, shelf-stable injectable glucagon pen to treat episodes of severe hypoglycemia.

First Basal-Bolus Insulin Delivery Patch Improves Poorly Controlled T2D

The V-Go (Valeritas) disposable wearable, daily insulin delivery patch is the first of its kind, all-in-one device designed to provide patients who have type 2 diabetes with continuous preset basal insulin and discrete, self-administered as-needed bolus dosing with meals.

The aim of this prandial insulin delivery device is to introduce insulin in a pattern that more closely matches the patient’s normal physiological needs to improve glycemic control.  

Clinical data presented at the Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting in Baltimore, Maryland offered evidence that this novel basal-bolus insulin product is more effective than multiple daily injections for glycemic control, utilization of insulin, and overall cost.1

“The simple, convenient manner in which V-Go delivers basal-bolus therapy continues to prove clinically beneficial and is patient-preferred,” according to the company. Each daily patch contains 36 bolus insulin units and a choice of three basal insulin rates (20 units, 30 units, 40 units).

Glucose control was improved in patients who used the V-Go with a prior history of failing to achieve good diabetes management according to both hemoglobin A1c and time-in-range values.1-3  Based on a prospective proof-of-concept pilot study (n=6), the average time-in-range for patients using the V-Go rose 35%.4

 “The goal is always to improve blood glucose time-in-range without increasing [risk of] hypoglycemia, and I am pleased to see switching to V-Go for insulin delivery achieved this goal and was preferred by patients over their prior insulin regimens,”1 said lead author Shreya Parikh, MD, an endocrinologist at the University of Texas McGovern Medical School in Sugar Land, based on a company release. She has not yet replied to a request from EndocrineWeb for comment.

First Oral Insulin, a Potential Game Changer, in Final Push

An oral insulin—a recombinant human insulin encapsulated in a propriety protein oral delivery formulation— is closer to reality for millions of adults with prediabetes and type 2 diabetes.

The oral formulation, ORMD-0801, under development by Oramed Pharmaceuticals, has just initiated a 90-day, phase 2b, randomized, placebo-controlled Food and Drug-sanctioned clinical trial of people with T2D (n=240) in multiple centers across the US.The oral pill will be given to patient groups at different doses and times throughout the day to demonstrate its impact on hemoglobin A1c levels.

This encapsulated oral insulin promises to address many of the limitations prohibiting ready acceptance to use injectable insulin among both clinicians and patients with type 2 diabetes, overcoming major barriers with a non-invasive, familiar delivery pill formulation that replaces the need for multiple dreaded injections.   

This oral capsule has undergone a placebo-controlled safety and efficacy study6, involving 180 patients who took the oral pill for at least 28 days. The results supported significantly lower Hg A1c levels with no serious side effects related to oral administration in a good representation of patients, including both sexes (54.7% female; 45.3% male) and ethnicities/races (48.4% Hispanic/Latino, 10.9% African American), with exceptional retention of participants for the duration of the trial.

A view of the study series leading to this point can be viewed at www.clinicaltrials.gov.7-10

Echoing what anyone having diabetes or managing patients would say, the CEO of Oramed, Nadav Kidron said, “Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin, but it also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin going directly to the liver rather than via the bloodstream.”

When swallowed, the active insulin is protected as the pill travels through the stomach and into the intestine where absorption is increased. The anticipated result is for patients to achieve better glucose control with minimal time-below-range (hypoglycemia) and time-above-range (hyperglycemia) as well as less undesirable weight gain.

Initiating insulin therapy earlier would decrease the burden on the pancreas, thereby preserving function for a longer period of time. 

The investigators believe the current trial will support a very favorable advance in glucose management. Results are expected in early 2019, which will set the stage for FDA approval.

Auto-Injectable Temperature-Stable Rescue Pen for Severe Hypoglycemia

Chicago-based Xeris is developing the G-Pen, a handheld glucagon (1 mg) subcutaneous rescue pen to treat severe hypoglycemia in patients with type 1 diabetes, which they expect will provide the first soluble, room-temperature stable, ready-to-inject glucagon delivery device.

While glucagon treatment is standard of care for all individuals with diabetes who are at risk for extreme hypoglycemic episodes, too few individuals who should have a rescue option are prepared because of the limitations in stability and ease of use.

The ready-to-use, auto-injectable pen is currently in a phase 3b clinical trial to evaluate treatment episodes using this investigational liquid-stable rescue device in comparison to current emergency glucagon delivery options, including preparation and administration times in the management of severe hypoglycemic episodes.11 This study was preceded by two phase 3 trials—one to evaluate response in adults7 and a second to test the product with a pediatric population (n=31).12

“We believe our glucagon auto-injector has the potential to offer benefits over currently marketed glucagon kits that require reconstitution and syringe filling prior to administration in a life-threatening emergency setting,” Paul Edick, chief executive officer, said in a company statement.

The company anticipates submitting an NDA application to the FDA before the end of the year. Xeris also has a bihormonal, closed-loop artificial pancreas under development.

 

 

Continue Reading:
Debating the Use of Continuous Glucose Monitoring in Type 2 Diabetes
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