Pramlintide, prandial insulin co-formulation gives benefits of both in one injection
medwireNews: A co-formulation of pramlintide and a prandial insulin offers improved postprandial glucose control and weight loss, without an increased number of injections, show the results of a small crossover trial.
Speaking at the virtual ADA 81st Scientific Sessions, Grégory Meiffren (Adocia, Lyon, France) said that based on these positive findings, the co-formulation will now be tested in a phase 2 clinical trial.
The drawback was an increased rate of gastrointestinal side effects, which the presenter said is a known issue with amylin analogs, but he added that these events “tend to disappear when the duration of use of pramlintide increases.”
The current study involved 15 people with type 1 diabetes who used the co-formulation (ADO09; pramlintide plus a novel prandial insulin) and insulin aspart for 24 days in a randomly assigned order, along with basal insulin degludec.
The study participants spent 2 days at the end of each period at the study site, during which postprandial glucose was measured. This revealed a greater than 100% reduction in glucose levels during the first 2 hours after a meal with ADO09 versus insulin aspart, and an average 69% reduction across a 4-hour postprandial period. Participants’ 1-hour plasma glucose was reduced by an average of 82 mg/dL (4.6 mmol/L).
Participants also had significantly slower gastric emptying and reduced glucagonemia when using ADO09 rather than insulin aspart.
During the outpatient part of each treatment period, participants spent an additional 58 minutes per day, on average, with their glucose levels within the range of 70–180 mg/dL (3.9–10.0 mmol/L). The amount of time spent in hyperglycemia was reduced by an average of 80 minutes, although there were also nonsignificant increases in the time spent in hypoglycemia, averaging 13 and 4 minutes for the 70 and 54 mg/dL (3.9 and 3.0 mmol/L) thresholds, respectively.
Fewer participants had hypoglycemia when using ADO09 than aspart, at 75.0% versus 81.3%, but there was a greater total number of events, at 96 versus 79. More participants had hypoglycemic events at night with ADO09 than aspart, but the number of events with blood glucose below 50 mg/dL (2.8 mmol/L) was the same for each treatment – four events in three participants.
Improved postprandial glucose control occurred despite a significant reduction in prandial insulin needs, averaging 12 U/day. Meiffren noted that use of the co-formulation based on insulin needs resulted in 27.1% of the participants’ injections containing more than 60 µg of pramlintide, which is the maximum dose currently allowed by the US FDA.
During the 24-week treatment period, participants lost an average of 1.6 kg when using ADO09, but gained an average 0.4 kg when using aspart.
The presenter stressed the significance of this finding, highlighting that the average baseline BMI of the cohort was 30.5 kg/m2.
Six study participants had nausea during the ADO09 treatment period, one had vomiting, and five had reduced appetite. Neither nausea nor vomiting occurred during the aspart treatment period, and one person reported reduced appetite while using aspart.
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