A Single-blind, Placebo-controlled, Dose-ranging Trial of Oral Hepatic-directed Vesicle Insulin Add-on to Oral Antidiabetic Treatment in Patients With Type 2 Diabetes Mellitus

Our results have shown that add-on oral hepatic-directed vesicleinsulin, in the dosage range 0.05 to 0.4 U/kg studied, significantly reduced mean postprandial plasma glucose area under the concentration-time curve values, compared to placebo, in patients with type 2 diabetes mellitus on oral antidiabetic drugs

W. Blair Geho

2014

Scholarcy highlights

  • The dose response of postprandial plasma glucose to add-on, premeal oral hepatic-directed vesicleinsulin, an investigational lipid bio-nanoparticle hepatocyte-targeted insulin delivery system, was evaluated in a 3-test-meal/day model in type 2 diabetes patients
  • Add-on oral HDV-I 0.05-0.4 U/kg significantly lowered PPG excursions and the dose response curve was flat. These results are consistent with the lack of a linear dose response between portal and systemic plasma insulin concentrations in previous animal and human studies
  • Despite the known benefits and potential advantages of intensive glycemic control in patients with type 2 diabetes mellitus, insulin treatment is often initiated late in the course of the disease following the failure of oral antidiabetic drugs or for a variety of other reasons, including fear of injections, weight gain, and hypoglycemia; fear of disease progression; patient and/or physician misperceptions about insulin; the unwillingness of physicians and their patients to initiate insulin therapy according to conventional recommendations referred to as “psychological insulin resistance”; and so on
  • The 3 treatment-emergent adverse events occurred in the same subject during oral HDV-I 0.4 U/kg treatment and included right and left forearm IV infiltrate and right forearm IV site tenderness
  • Our results have shown that add-on oral HDV-I, in the dosage range 0.05 to 0.4 U/kg studied, significantly reduced mean postprandial plasma glucose area under the concentration-time curve values, compared to placebo, in patients with type 2 diabetes mellitus on OAD
  • Add-on oral HDV-I across all the doses tested resulted in clinically meaningful reductions in postprandial plasma glucose AUC in patients with type 2 diabetes mellitus on stable OAD therapy over the 3-meal study period
  • Results of long-term randomized controlled trials are required to achieve this potential

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