OR WAIT null SECS
The team estimated the time to individual plasma glucose recovery following exposure to the medication.
Investigators from Slovenia estimated the true but unmeasured time to individual plasma glucose (PG) recovery following treatment with the novel glucagon analog dasiglucagon featured in phase 2 and phase 3 registration trials for the treatment of hypoglycemia.
The team, led by Tadej Battelino, MD, PhD, University Medical Center Ljubljana and University of Ljubljana, estimated that the true time to recovery for dasiglucagon was 8.7 minutes in the phase 2 trial featured in the study and roughly 9 to 9.3 minutes in phase 3 trials.
The data was presented during the session “Predicting true time to recovery from insulin-induced hypoglycemia with dasiglucagon,” during the 19th World Congress Insulin Resistance Diabetes & Cardiovascular Disease CME Conference (WCIRDC).
Dasiglucagon had previously undergone an extensive clinical development program, and was approved by the US Food and Drug Administration (FDA) for the use in severe hypoglycemia in children and adults patients with diabetes aged 6 years and older.
During the phase 2 and phase 3 trials, the primary and secondary endpoints included time to plasma glucose recovery from insulin-induced hypoglycemia, which was defined as first plasma glucose increase ≥20 mg/dL after treatment initiation without the need for intravenous glucose.
Different plasma glucose sampling schemes were used in phase 2 and phase 3 trials, the former of which involved 5-minute intervals and the latter having more frequent intervals.
For the present study, investigators believed that linear interpolation enabled a better measure of actual time to plasma glucose recovery in patients receiving dasiglucagon.
Linear interpolation between the 2 tome points featured in the trials before and after plasma glucose recovery occurred was calculated.
According to investigators, this interpolation assumed that plasma glucose increased linearly in the limited time interval between 2 consecutive time points.
In the trials included in the present study, the linear interpolation estimated a 20-mg/dL PG increase would occur earlier than the observed time to PG recovery.
In a representative patient, a PG sample taken at 10 minutes was considered the first sample that showed an increase of at least 20 mg/dL from the pre-dose level. The observed time to PG recovery for this patient was 10 minutes.
Linear interpolation estimated that the increase of 20 mg/dL occurred at 9 minutes. Additionally, linear interpolation estimated that PG recovery occurred earlier than the predetermined time point in patients treated with dasiglucagon.
The observed time to PG recovery was considered a discrete measure dependent on the PG sampling scheme, and linear interpolation of PG recovery estimated the true time to recovery on a continuous time scale.
Battelino and colleagues reported that th median estimated true time to recovery with dasiglucagon ranged from 8.7 to 9.3 minutes across trials.
“These results confirm the consistent efficacy of dasiglucagon for the treatment of hypoglycemia,” the team wrote. “Estimating true time to recovery enables better comparison between trials versus observed time to PG recovery only.”