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Fast-Acting Human Insulin, HinsBet, Shows Promise in Mid-Stage Trial

Treatment more effective than Humulin

Positive results have been reported from a phase IIa clinical trial evaluating a fast-acting formulation of recombinant human insulin, HinsBet (Adocia), in comparison with Humalog (insulin lispro) and Humulin (recombinant human insulin), both marketed by Eli Lilly.

The HinsBet formulation incorporates proprietary BioChaperone technology, which allows accelerated absorption of prandial insulins.

The new study met its primary endpoint: the increase in recombinant human insulin bioavailability during the first hour of therapy with HinsBet compared with Humulin. The main objective for prandial insulins is to mimic the physiological response to a meal with an absorption of subcutaneous insulin as fast as possible. Therefore, the effect of prandial insulins in the first hour is critical. The new clinical results show that HinsBet has an early effect equivalent to that of a fast-acting insulin analog, Humalog, and twice as fast that of regular recombinant human insulin, Humulin.

In the double-blind crossover study, the pharmacokinetic and pharmacodynamic characteristics of HinsBet were compared with those of Humulin and Humalog. Thirty-six patients with type-1 diabetes received a single 0.2-U/kg dose of HinsBet, Humulin, or Humalog under automated euglycemic clamp conditions (target blood glucose: 100 mg/dL; clamp duration: 10 hours post-dosing).

All three formulations were well tolerated and did not induce local reactions.

HinsBet demonstrated a significantly faster rate of absorption compared with Humulin (the study’s primary endpoint), with a 70% increase in early insulin exposure (AUCins_0–1h = 26.0 vs. 15.5 h*mU/L, respectively; P < 0.0001).

The metabolic effect was triggered significantly earlier with HinsBet than with Humulin, with a 70% faster onset of action (time to onset, 28 vs. 49 minutes, respectively; P < 0.0001). Moreover, the metabolic effect of HinsBet was more than twice that of Humulin within the first hour after administration (AUCGIR_0–1h= 111 vs. 46 mg/kg; P < 0.0001).

Finally, the total insulin exposure and the potency of recombinant human insulin were similar for HinsBet and Humulin (AUCins_0–last = 158 vs. 152 h*mU/L, respectively, and AUCGIR_0–last = 1,294 vs. 1,256 h*mU/L).

HinsBet demonstrated an absorption rate similar to that of Humalog with no significant difference in early exposure (AUCins_0–30min = 10.7 vs. 11.5 h*mU/L, respectively). This similar absorption also translated into a similar early metabolic effect between HinsBet and Humalog (AUCGIR_0–1h = 111 vs. 130 mg/kg).

Prandial insulins include regular human insulin and fast-acting insulin analogs. The main objective of prandial insulins is to control the rapid rise in glycemia associated with the digestion of meals. Available prandial insulins need to be injected 15 minutes (insulin analogs) to 30 minutes (regular human insulin) before mealtime. This delay makes it difficult for patients to correctly dose insulin relative to the actual meal and usually results in unsatisfactory glycemic control (i.e., hyper- or hypoglycemia).

Source: Adocia; February 5, 2015.

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