medwireNews: The novel oral insulin ORMD-0801 warrants further investigation as a treatment option for patients with inadequately controlled type 2 diabetes, indicate findings from a phase 2b trial presented at the virtual 56th EASD Annual Meeting.
Roy Eldor (Tel Aviv Sourasky Medical Center, Israel) explained that ORMD-0801 “is a novel human insulin formulation, which integrates both a species-specific protease inhibitor” to prevent degradation in the gastrointestinal tract, along with “a potent absorption enhancer that promotes absorption of the active ingredient across the intestinal epithelium.”
The team carried out a placebo-controlled, dose-ranging study to evaluate the efficacy of ORMD-0801 8 mg, 16 mg, or 32 mg given once or twice daily, or 32 mg given three times daily, in 347 patients with type 2 diabetes and glycated hemoglobin (HbA1c) levels of at least 7.5% (58 mmol/mol) despite standard treatment.
In addition to stable metformin treatment, participants were taking up to two oral antidiabetic agents prior to study enrolment, but those using glucagon-like peptide-1 receptor agonists within 3 months of the trial were excluded.
After 12 weeks of treatment, patients treated with the 8 mg or 32 mg doses once or twice daily experienced significantly greater average reductions in HbA1c levels than those in the placebo arm. These reductions ranged from 0.6% in the 32 mg once and twice daily arms to 1.0% in both 8 mg groups, compared with 0.1% in the placebo group. By contrast, participants treated with the 16 mg once daily dose experienced an average 0.1% increase in HbA1c.
Eldor said that “a similar trend was noted” for glucose area under the curve as measured by continuous glucose monitoring.
These benefits were seen “without a clear increase in hypoglycemia [and] without weight gain,” he added. Indeed, the number of hypoglycemia events ranged from none to 32 for participants in the active treatment groups, compared with 25 in the placebo arm. Average weight change ranged from a 1.4 kg loss for patients treated with ORMD-0801 8 mg once daily to a 0.8 kg gain for those given 16 mg twice daily, compared with a 0.3 kg decrease in the placebo arm.
The presenter added that ORMD-0801 treatment did not lead to an increased risk for serious or severe adverse events.
These findings suggest that “there is no significant benefit to be derived from dosing more than once daily,” said Eldor. Noting that the once-daily groups took ORMD-0801 at bedtime, he said this dose would likely optimize treatment adherence and reduce costs.
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