Time to Plasma Glucose Recovery
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 10.00 |
| Placebo | 30.00 |
| GlucaGen® 1.0 mg | 10.00 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Germany, Slovenia
1 trial · 1 completed · 1 with posted results
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
NCT0366705328 Sept 2018 to 28 Jun 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin
Experimental
dasiglucagon
Single fixed dose (s.c.injection) of dasiglucagon
Placebo comparator
placebo
Single fixed dose (s.c.injection) of placebo
Active comparator
GlucaGen®
Single fixed dose (s.c.injection) of GlucaGen®
Outcomes the sponsor listed as primary.
Time to Plasma Glucose Recovery
Time frame · 0-45 minutes after dosing
Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes. Time to plasma glucose recovery was summarized for each treatment group using Kaplan Meier (KM) estimates together with the 95% confidence interval. Note that the upper confidence limit for the placebo median was not estimable, but is set to 45 minutes (censored value) here.
Plasma Glucose Recovery
Time frame · 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue intravenous (IV) glucose. Plasma glucose recovery was defined as the first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.
Plasma Glucose Changes From Baseline
Time frame · 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Plasma glucose changes from baseline within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial product injection or at the time of rescue intravenous (IV) glucose
Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)
Time frame · 0-30 minutes
Plasma glucose response as area under the effect curve above baseline from time 0 to 30 minutes (AUE0-30min). Plasma glucose was determined at pre-dose and at 4, 6, 8, 10, 12, 15, 17, 20, 30, and 45 minutes (and at 60 minutes if the patient weighed ≥21 kg) after dosing.
Administration of Rescue IV Glucose Infusion After IMP Injection
Time frame · 0-45 minutes
Number of patients receiving IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Time to First IV Glucose Infusion After IMP Administration
Time frame · 0-45 minutes
Time to first IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Pharmacokinetics: AUC0-30 Min
Time frame · 0-30 minutes
Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to 30 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: AUC0-300min
Time frame · 0-300 minutes
Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to 300 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: AUC0-inf
Time frame · 0-300 minutes
Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to infinitely post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: Cmax
Time frame · 0-300 minutes
Maximum of all valid plasma dasiglucagon or GlucaGen concentration measurements from 0 to 300 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: Tmax
Time frame · 0-300 minutes
Time to maximum of plasma dasiglucagon or GlucaGen concentration measurements. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: λz
Time frame · 0-300 minutes
Terminal elimination rate constant of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: t½
Time frame · 0-300 minutes
Terminal plasma elimination half-life of dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: CL/f
Time frame · 0-300 minutes
Total body clearance of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: Vz/f
Time frame · 0-300 minutes
Volume of distribution of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Pharmacokinetics: MRT
Time frame · 0-300 minutes
Mean residence time of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 10.00 |
| Placebo | 30.00 |
| GlucaGen® 1.0 mg | 10.00 |
| Group | Value (Participants) |
|---|---|
| Dasiglucagon 0.6 mg | 20 |
| Placebo | 6 |
| GlucaGen® 1.0 mg | 10 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 98.459 | 19.6527 |
| Placebo | 17.510 | 15.6313 |
| GlucaGen® 1.0 mg | 85.225 | 12.5052 |
| Group | Value (mmol*h/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 22.83 | 6.126 |
| Placebo | 1.81 | 4.641 |
| GlucaGen® 1.0 mg | 19.66 | 3.410 |
| Group | Value (Participants) |
|---|---|
| Dasiglucagon 0.6 mg | 0 |
| Placebo | 1 |
| GlucaGen® 1.0 mg | 0 |
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | not posted |
| Placebo | 12 |
| GlucaGen® 1.0 mg | not posted |
| Group | Value (h*pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 376 | 78.1 |
| GlucaGen® 1.0 mg | 376 | 63.3 |
| Group | Value (h*pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1810 | 44.8 |
| GlucaGen® 1.0 mg | 1370 | 72.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Age Group 6-11 Years - DasiglucagonPatients in the dasiglucagon group in the age group 6-11 years | 0 / 8 | 0 / 8 | 3 / 8 |
| Age Group 6-11 Years - PlaceboPatients in the placebo group in the age group 6-11 years | 0 / 4 | 0 / 4 | 1 / 4 |
| Age Group 6-11 Years - GlucaGenPatients in the GlucaGen group in the age group 6-11 years | 0 / 4 | 0 / 4 | 4 / 4 |
| Age Group 12-17 Years - DasiglucagonPatients in the dasiglucagon group in the age group 12-17 years | 0 / 12 | 0 / 12 | 12 / 12 |
| Age Group 12-17 Years - PlaceboPatients in the placebo group in the age group 12-17 years | 0 / 7 | 0 / 7 | 6 / 7 |
| Age Group 12-17 Years - GlucagenPatients in the GlucaGen group in the age group 12-17 years | 0 / 6 | 0 / 6 | 5 / 6 |
| Dasiglucagon 0.6 mgFull population. Single fixed dose (subcutaneous injection) of dasiglucagon | 0 / 20 | 0 / 20 | 15 / 20 |
| PlaceboFull population. Single fixed dose (subcutaneous injection) of placebo | 0 / 11 | 0 / 11 | 7 / 11 |
| GlucaGen® 1.0 mgFull population. Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg) | 0 / 10 | 0 / 10 | 9 / 10 |
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