medwireNews: The risk for hypoglycemia from an accidental basal insulin overdose is no higher with weekly insulin icodec than with daily glargine U100 in people with type 2 diabetes, report researchers.
The trial consisted of a run-in period to optimize insulin glargine dose followed by either 6 weeks of weekly insulin icodec injections or 11 days of daily glargine injections in a randomly assigned order with a washout period between them.
During the icodec phase, the 43 trial participants received a double dose at week 3 and a triple dose at week 6; during the glargine phase they received double and triple doses on days 4 and 11 respectively.
The 43 trial participants (72% men) were an average age of 56.3 years, with an average diabetes duration of 13.5 years. Their average glycated hemoglobin level was 7.2%, and 95% were taking oral antidiabetic agents.
The participants’ vulnerability to hypoglycemia was tested 44 hours after icodec injection and 7 hours after glargine injection – at the estimated time of maximum glucose-lowering effect for these insulins.
The minimum glucose level allowed was 45 mg/dL (2.5 mmol/L), at which point the participants received a glucose infusion to achieve euglycemia, Thomas Pieber (Medical University of Graz, Austria) told delegates at the 82nd ADA Scientific Sessions in New Orleans, Louisiana.
The team found that 40% of people experienced glucose levels below 54 mg/dL (3.0 mmol/L) following a double dose of icodec, and 36% did so after a double dose of glargine. The corresponding rates after triple doses of these insulins were 53% and 70%, with no significant difference between the two.
The rate of participants experiencing plasma glucose of 45 mg/dL or lower after a double dose was not significantly different between the icodec and glargine phases, at 4.7% and 7.1%, respectively. But the corresponding rates after the triple doses were 2.6% versus 25.0%, which was a significant difference favoring icodec.
Likewise, the average nadir glucose level achieved was a comparable 58 and 59 mg/dL (3.22 and 3.27 mmol/L) after the double doses of icodec and glargine, respectively, but a significantly different 56 and 52 mg/dL (3.1. and 2.88 mmol/L) after the triple doses.
There were no differences in hypoglycemia symptoms or in glucagon or growth hormone response during hypoglycemia due to overdoses of icodec or glargine.
However, the participants had significantly larger cortisol and epinephrine (adrenaline) responses during hypoglycemia following icodec versus glargine, and a trend toward a larger norepinephrine (noradrenaline) response.
In response to a question, Pieber said that participants were monitored for 4 days after the double and triple icodec doses, during which recurrent hypoglycemia episodes were rare and mild, and “easily compensated with oral carbohydrates.”
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