7. Drug Updates

FDA approves Novo Nordisk fast-acting insulin Fiasp

The U.S. Food and Drug Administration approved Novo Nordisk's fast-acting insulin to treat diabetes. The product, named as Fiasp, is designed to help diabetes affected patients to control post-meal spikes in blood sugar. The product was already approved for use in Canada and Europe.

This faster-acting formulation of insulin aspart gets absorbed more quickly and works faster than conventional fast acting insulin like aspart or lispro, and thus more closely resembles the natural physiological insulin response to meals.

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Degludec gets label update for reduction in severe hypoglycemia!

The European Medicines Agency's CHMP on 29th September 2017 has endorsed an update of the European Union label with immediate effect for Tresiba® (insulin degludec) to include DEVOTE trial results on severe hypoglycaemia.

DEVOTE is a randomized, multinational and double-blinded trial that was carried out to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 among people with type 2 diabetes, over 104 weeks. It is the first cardiovascular outcomes trial (CVOT) comparing two basal insulins.

In the trial, Tresiba was non-inferior to insulin glargine U100 in terms of major adverse cardiovascular events (MACE) and also showed statistically significant reductions in severe hypoglycemic events (-40%) including nocturnal severe hypoglycaemia (-53%).

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Sustain-7 trial Proves Superiority of Semaglutide over Dulaglutide

Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analog in development for the treatment of adults with type 2 diabetes.

In a recent head-to-head trial (Sustain-7 trial) that compared Novo Nordisk’s Semaglutide to Eli Lilly’s once-weekly Dulaglutide (brand name Trulicity), the former was found to out-perform the latter. In the 40-week, Phase IIIb study, semaglutide achieved better HbA1c reduction (-1.5% with 0.5mg dose and -1.8% with 1 mg dose) than dulaglutide (-1.1% with 0.75mg dose and -1.4% with 1.5 mg dose). Similarly in semaglutide group, more percentage of patients reached treatment goals and achieved significantly greater weight loss than the other group.

The results obtained from the trial such as semaglutide’s superior glucose control and weight loss when compared to dulaglutide, reinforces the unprecedented results observed in the entire SUSTAIN programme.

Semaglutide is now under review by many regulatory agencies, including the FDA (USA), the EMA (Europe) and PMDA (Japan).

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DEPICT-1: Dapagliflozin Works in T1D With Little Ketoacidosis

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that has been approved for treating type 2 diabetes. In the DEPICT-1 study, researchers assessed the efficacy and safety of dapagliflozin as an oral adjunct to insulin in patients with inadequately controlled type 1 diabetes (T1D). This is the first phase 3 clinical trial of the newer selective SGLT2 inhibitor in T1D.

The study published in Lancet Diabetes and Endocrinology shows that dapagliflozin at doses 5 mg and 10 mg provided clinically relevant benefits as add-on to adjustable insulin, compared with placebo. The incidence of diabetic ketoacidosis was approximately the same across both the groups. Over 24 weeks of study, both doses of dapagliflozin were significantly beneficial compared to placebo in improving HbA1c [5 mg vs placebo= -0.42% (P < .0001), 10 mg vs placebo= -0.45% (P < .0001)], body mass index [5 mg vs placebo= -2.96% (P < .0001), 10 mg vs placebo= -3.72% (P < .0001)], and Total daily insulin dose [5 mg vs placebo= -8.8% (P < .0001), 10 mg vs placebo= -13.2% (P < .0001)]. Hypoglycemia and other common adverse events reported were similar across the groups. Results obtained give hope for a prompt registration of dapagliflozin as adjunct therapy in T1D.

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