Diabetes is one of the most prevalent conditions in the United States, with figures from the Centers for Disease Control and Prevention suggesting almost one in ten people live with the condition, the equivalent to 30 million people across the country.
The majority of cases - nine out of ten - are type 2 diabetes, the symptoms of which can often be alleviated and controlled with lifestyle changes such as eating a healthier diet and getting more exercise. However, there are many treatments and medications available to help patients monitor and improve glycemic control and treat the symptoms of diabetes.
In 2017, the US Food and Drug Administration (FDA) approved a number of new drugs and devices as treatments and therapies for diabetes…
1. Steglatro (ertugliflozin)
Last year, pharmaceutical giants Merck and Pfizer were granted FDA approval for Steglatro (ertugliflozin), a new sodium glucose co-transporter 2 inhibitor (SGLT2 inhibitor). Steglatro is indicated as an adjunct treatment to be used alongside diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.
Following its approval in December 2017, Steglatro is set to appear in US pharmacies in January 2018. The drug will also be available as part of two combination medications: Steglujan (ertugliflozin and sitagliptin), which pairs it with Merck’s diabetes drug Januvia (sitagliptin); and Segluromet (ertugliflozin and metformin hydrochloride) which combines it with metformin.
SGLT2 inhibitors lower a patient’s blood sugar levels by causing the kidneys to remove sugar via the urine. Steglatro is available in 5mg or 15mg tablets, with a recommended starting dose of 5mg. It was one of 46 novel drugs granted FDA approval last year. To date, the FDA has not approved the use of SGLT2 inhibitors for the treatment of patients with type 1 diabetes.
While a welcome addition to pharmacies, Steglatro is not the first SGLT2 inhibitor available as three similar drugs are currently available. The first SGLT2 inhibitor diabetes treatment to market was Invokana (canagliflozin) from Johnson & Johnson, while Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca Farxiga (dapagliflozin) are also options.
2. Ozempic (semaglutide)
Novo Nordisk’s Ozempic (semaglutide) is the latest glucagon-like peptide 1 (GLP-1) receptor agonist approved as an adjunct therapy to improve glycemic control in adult patients with type 2 diabetes mellitus. The subcutaneous injectable medication gained an FDA nod in December 2017 and is indicated as an adjunct treatment to be used alongside improved diet and exercise.
Ozempic is administered by patients themselves via an injector pen, of which two are available; one delivering 0.25mg or 0.5mg per injection, the other administering a 1mg dose. It is similar to a natural hormone found in the body and works by causing insulin release in response to high blood sugar and by decreasing the amount of sugar created in the liver.
The FDA’s approval of Ozempic takes the number of approved GLP-1 receptor agonists available in the United States up to six. Similar alternative medications in this drug class include Trulicity (dulaglutide) from Eli Lilly and Tanzeum (albiglutide), manufactured by GlaxoSmithKline.
3. Admelog (insulin lispro injection)
In September 2017, Sanofi-Aventis US was granted FDA approval for Admelog (insulin lispro injection), a short-acting insulin to be used as a “follow-on” product which gained final approval in December. Follow-on products are those which qualify for an abbreviated pathway to approval due to their similarity to another product, in this case, Humalog (insulin lispro).
The drug is indicated for the treatment of type 1 diabetes mellitus in pediatric patients over the age of three and in adults. Admelog also gained approval as a treatment for adults with type 2 diabetes. Short-acting insulin products are generally administered just before eating to help control blood sugar levels after a meal.
Admelog has a number of routes of administration: subcutaneous injection (injection under the skin; subcutaneous infusion (for instance, with an insulin pump); or as an intravenous infusion. The medication will be available either in vial form or in the disposable insulin pen.
4. FreeStyle Libre Flash Glucose Monitoring System
The FreeStyle Libre Flash Glucose Monitoring System from Abbott Diabetes Care Inc is likely to be an exciting new development in diabetes management for many patients across the United States. It is the first continuous glucose monitoring system that does not need calibrating using a blood sample from the fingertip.
Users have a small sensor wire that lasts for up to ten days is inserted under the skin on the arm. This continuously monitors and measures blood glucose levels and can be read simply by waving a mobile reader above the sensor wire.
The device gained FDA approval in September this year for use in adult patients who need to make diabetes treatment decisions.
5. Dermapace System
At the end of 2017, the FDA permitted the marketing of the first shockwave device to help treat patients with diabetic foot ulcers. The Dermapace System from Sanuwave is intended for use treating chronic full-thickness diabetic foot ulcers with wound areas less than 16cm2 which extend through the epidermis, dermis tendon, or capsule, but without bone exposure.
It is an external shock wave system using energy pulses to mechanically stimulate the wound and should be used along with the standard diabetic ulcer care.
The device received a nod from the FDA following a review of clinical data from two studies involving a total of 336 patients. The agency suggested improving options for treating and healing ulcer wounds may help reduce the number of lower limb amputations as a result of diabetic ulcers.