Congenital Hyperinsulinism
Conditions
Brief summary
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
Interventions
DRUGdasiglucagon
Glucagon analogue
DRUGPlacebo
Placebo for dasiglucagon
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Days to 364 Days
Healthy volunteers
No
Inclusion criteria
* CHI diagnosis established based on the following: 1. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or 2. Hypofattyacidemia: plasma free fatty acid \<1.7 mmol/L, and/or 3. Hypoketonemia: Beta-hydroxybutyrate \<1.8 mmol/L, and/or 4. Glycemic response: an increase in plasma glucose (PG) of \>30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration * Male or female, age ≥7 days and \<12 months at screening * Body weight of ≥2.0 kg (4.4 lbs.) * Continuous IV glucose requirement to prevent hypoglycemia
Exclusion criteria
* Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress) * Was born preterm below 34 weeks of gestational age * Presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma * Known or suspected presence of severe brain damage * Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism * Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m\^2 body surface area or equivalent within 5 days before screening * Prior use of lanreotide, sirolimus (mechanistic target of rapamycin \[mTOR\] inhibitors), anti-inflammatory biological agents, or other immune modulating agents. Prior use of octreotide is allowed after a minimum of 48 hour washout before randomization. * Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject's ability to participate in the trial * Any recognized clotting or bleeding disorder * The use of prescription or non-prescription medications known to cause QT prolongation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intravenous Glucose Infusion Rate | Hours 36-48 after initiation of trial drug (Part 1) | Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intravenous Glucose Infusion Rate | 48 hours after initiation of trial drug (Part 1) | Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Hours 36-48 after initiation of trial drug (Part 1) | Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no) |
| Time to Complete Weaning Off Intravenous Glucose | Days 5 to 25 (Part 2) | Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours. |
| Hypoglycemia Event Rate in Part 2 | Days 5 to 25 | Hypoglycemia event rate, defined as number of hypoglycemic events when PG was \<70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose. |
| Clinically Significant Hypoglycemia Events in Part 2 | Days 5 to 25 | Clinically significant hypoglycemia event rate, defined as number of events when PG was \<54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose. |
| Time to Actual Hospital Discharge | Days 5 to 25 | Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital. |
| Time to Pancreatic Surgery | Days 5 to 25 | Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%). |
| Carbohydrates Administered Intravenously | Days 5 to 25 | Amount (g) of carbohydrates administered via IV glucose infusion or bolus or total parenteral nutrition. This secondary endpoint was intended to account only for carbohydrates administered via IV glucose infusion or bolus. It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition from the collected data. This endpoint was expanded to include both. |
| Carbohydrates Administered Parenterally | Days 5 to 25 | Amount (g) of carbohydrates administered as part of total parenteral nutrition. |
| Carbohydrates Administered | 0 to 48 hours after initiation of trial drug | Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day. |
| Carbohydrates Administered Via Gastric Feed | Days 5 to 25 | Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy. |
| Time in Range in Part 2 | Days 5 to 25 | Percent time in range (PG between 70 to 180 mg/dL \[3.9-10.0 mmol/L\]) as measured by continuous glucose monitoring. |
| Time in Hypoglycemia in Part 2 | Days 5 to 25 | Percent time in hypoglycemia (when PG was \<70 mg/dL \[or 3.9 mmol/L\]) as measured by continuous glucose monitoring. |
| Time in Clinically Significant Hypoglycemia in Part 2 | Days 5 to 25 | Percent time in clinically significant hypoglycemia (when PG was \<54 mg/dL \[or 3.0 mmol/L\]) as measured by continuous glucose monitoring. |
| Hypoglycemia Episodes in Part 2 | Days 5 to 25 | Rate of hypoglycemia episodes, defined as number of episodes per week when PG was \<70 mg/dL (3.9 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. |
| Clinically Significant Hypoglycemia Episodes in Part 2 | Days 5 to 25 | Rate of clinically significant hypoglycemia episodes, defined as number of episodes per week when was \<54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring. |
| Extent of Hypoglycemia in Part 2 | Days 5 to 25 | Extent of hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring. |
| Extent of Clinically Significant Hypoglycemia in Part 2 | Days 5 to 25 | Extent of clinically significant hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 54 mg/dL \[3.0 mmol/L\]) as measured by continuous glucose monitoring, divided by the total duration in hours of continuous glucose monitoring. |
| Time in Hyperglycemia in Part 2 | Days 5 to 25 | Percent time in hyperglycemia (when PG was \>180 mg/dL \[10.0 mmol/L\]), as measured by continuous glucose monitoring. |
| Carbohydrates Administered Orally | Days 5 to 25 | Amount (g) of carbohydrates administered via oral route. |
Countries
Germany, Israel, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Who Received Treatment All participants who received treatment | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants Who Received Treatment |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 71.25 Days STANDARD_DEVIATION 84.976 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gastrostomy/nasogastric tube Gastrostomy | 2 Participants |
| Gastrostomy/nasogastric tube Nasogastric tube | 7 Participants |
| Gastrostomy/nasogastric tube None | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 8 Participants |
| Region of Enrollment Germany | 1 participants |
| Region of Enrollment United Kingdom | 3 participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 1 |
| other Total, other adverse events | 3 / 12 | 7 / 12 | 10 / 12 | 10 / 12 | 1 / 1 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 1 / 12 | 1 / 12 | 0 / 1 |
Outcome results
Primary
Mean Intravenous Glucose Infusion Rate
Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Time frame: Hours 36-48 after initiation of trial drug (Part 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasiglucagon | Mean Intravenous Glucose Infusion Rate | 4.33 mg/kg/minute | Standard Deviation 4.922 |
| Placebo | Mean Intravenous Glucose Infusion Rate | 9.51 mg/kg/minute | Standard Deviation 5.655 |
Comparison: Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebop-value: 0.003795% CI: [-8.29, -2.13]Mixed Models Analysis
Secondary
Carbohydrates Administered
Total amount (g) of carbohydrates administered (regardless of the route) per day.
Time frame: Days 5 to 25
Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Carbohydrates Administered | Week 1 (Days 5 to 11) | 91.03 g/day |
| Dasiglucagon | Carbohydrates Administered | Week 2 (Days 12 to 18) | 75.09 g/day |
| Dasiglucagon | Carbohydrates Administered | Week 3 (Days 19 to 25) | 80.73 g/day |
| Dasiglucagon | Carbohydrates Administered | Weeks 1 to 3 (Days 5 to 25) | 87.37 g/day |
Secondary
Carbohydrates Administered
Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day.
Time frame: 0 to 48 hours after initiation of trial drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasiglucagon | Carbohydrates Administered | 106.7 g/day | Standard Deviation 53.72 |
| Placebo | Carbohydrates Administered | 139.1 g/day | Standard Deviation 57.35 |
Comparison: Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebop-value: 0.023895% CI: [-56.8, -5.05]Mixed Models Analysis
Secondary
Carbohydrates Administered Intravenously
Amount (g) of carbohydrates administered via IV glucose infusion or bolus or total parenteral nutrition. This secondary endpoint was intended to account only for carbohydrates administered via IV glucose infusion or bolus. It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition from the collected data. This endpoint was expanded to include both.
Time frame: Days 5 to 25
Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Carbohydrates Administered Intravenously | Week 1 (Days 5 to 11) | 41.35 g/day |
| Dasiglucagon | Carbohydrates Administered Intravenously | Week 2 (Days 12 to 18) | 2.12 g/day |
| Dasiglucagon | Carbohydrates Administered Intravenously | Week 3 (Days 19 to 25) | 0.35 g/day |
| Dasiglucagon | Carbohydrates Administered Intravenously | Weeks 1 to 3 (Days 5 to 25) | 22.60 g/day |
Secondary
Carbohydrates Administered Orally
Amount (g) of carbohydrates administered via oral route.
Time frame: Days 5 to 25
Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Carbohydrates Administered Orally | Week 1 (Days 5 to 11) | 19.57 g/day |
| Dasiglucagon | Carbohydrates Administered Orally | Week 2 (Days 12 to 18) | 0.37 g/day |
| Dasiglucagon | Carbohydrates Administered Orally | Week 3 (Days 19 to 25) | 0.23 g/day |
| Dasiglucagon | Carbohydrates Administered Orally | Weeks 1 to 3 (Days 5 to 25) | 13.38 g/day |
Secondary
Carbohydrates Administered Parenterally
Amount (g) of carbohydrates administered as part of total parenteral nutrition.
Time frame: Days 5 to 25
Population: It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition because some of the carbohydrates that were given as a part of parenteral nutrition were also reported as carbohydrates administered intravenously. All available results regarding administration of carbohydrates are presented in outcome measure 11.
Secondary
Carbohydrates Administered Via Gastric Feed
Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy.
Time frame: Days 5 to 25
Population: Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Carbohydrates Administered Via Gastric Feed | Week 1 (Days 5 to 11) | 34.43 g/day |
| Dasiglucagon | Carbohydrates Administered Via Gastric Feed | Week 2 (Days 12 to 18) | 52.87 g/day |
| Dasiglucagon | Carbohydrates Administered Via Gastric Feed | Week 3 (Days 19 to 25) | 57.90 g/day |
| Dasiglucagon | Carbohydrates Administered Via Gastric Feed | Weeks 1 to 3 (Days 5 to 25) | 43.96 g/day |
Secondary
Clinically Significant Hypoglycemia Episodes in Part 2
Rate of clinically significant hypoglycemia episodes, defined as number of episodes per week when was \<54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Clinically Significant Hypoglycemia Episodes in Part 2 | Week 1 (Days 5 to 11) | 5.00 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Episodes in Part 2 | Week 2 (Days 12 to 18) | 8.50 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Episodes in Part 2 | Week 3 (Days 19 to 25) | 2.67 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Episodes in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 5.00 episodes per week |
Secondary
Clinically Significant Hypoglycemia Events in Part 2
Clinically significant hypoglycemia event rate, defined as number of events when PG was \<54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose.
Time frame: Days 5 to 25
Population: Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Clinically Significant Hypoglycemia Events in Part 2 | Week 1 (Days 5 to 11) | 1.67 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Events in Part 2 | Week 2 (Days 12 to 18) | 1.00 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Events in Part 2 | Week 3 (Days 19 to 25) | 2.92 episodes per week |
| Dasiglucagon | Clinically Significant Hypoglycemia Events in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 1.67 episodes per week |
Secondary
Extent of Clinically Significant Hypoglycemia in Part 2
Extent of clinically significant hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 54 mg/dL \[3.0 mmol/L\]) as measured by continuous glucose monitoring, divided by the total duration in hours of continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Extent of Clinically Significant Hypoglycemia in Part 2 | Week 1 (Days 5 to 11) | 0.14 mg/dL/hour |
| Dasiglucagon | Extent of Clinically Significant Hypoglycemia in Part 2 | Week 2 (Days 12 to 18) | 0.13 mg/dL/hour |
| Dasiglucagon | Extent of Clinically Significant Hypoglycemia in Part 2 | Week 3 (Days 19 to 25) | 0.12 mg/dL/hour |
| Dasiglucagon | Extent of Clinically Significant Hypoglycemia in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 0.14 mg/dL/hour |
Secondary
Extent of Hypoglycemia in Part 2
Extent of hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Extent of Hypoglycemia in Part 2 | Week 1 (Days 5 to 11) | 0.87 mg/dL/hour |
| Dasiglucagon | Extent of Hypoglycemia in Part 2 | Week 2 (Days 12 to 18) | 0.97 mg/dL/hour |
| Dasiglucagon | Extent of Hypoglycemia in Part 2 | Week 3 (Days 19 to 25) | 0.59 mg/dL/hour |
| Dasiglucagon | Extent of Hypoglycemia in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 0.89 mg/dL/hour |
Secondary
Hypoglycemia Episodes in Part 2
Rate of hypoglycemia episodes, defined as number of episodes per week when PG was \<70 mg/dL (3.9 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Hypoglycemia Episodes in Part 2 | Week 1 (Days 5 to 11) | 25.00 episodes per week |
| Dasiglucagon | Hypoglycemia Episodes in Part 2 | Week 2 (Days 12 to 18) | 26.50 episodes per week |
| Dasiglucagon | Hypoglycemia Episodes in Part 2 | Week 3 (Days 19 to 25) | 18.63 episodes per week |
| Dasiglucagon | Hypoglycemia Episodes in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 18.54 episodes per week |
Secondary
Hypoglycemia Event Rate in Part 2
Hypoglycemia event rate, defined as number of hypoglycemic events when PG was \<70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose.
Time frame: Days 5 to 25
Population: Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Hypoglycemia Event Rate in Part 2 | Week 1 (Days 5 to 11) | 8.50 episodes per week |
| Dasiglucagon | Hypoglycemia Event Rate in Part 2 | Week 2 (Days 12 to 18) | 6.0 episodes per week |
| Dasiglucagon | Hypoglycemia Event Rate in Part 2 | Week 3 (Days 19 to 25) | 3.79 episodes per week |
| Dasiglucagon | Hypoglycemia Event Rate in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 6.04 episodes per week |
Secondary
Mean Intravenous Glucose Infusion Rate
Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Time frame: 48 hours after initiation of trial drug (Part 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasiglucagon | Mean Intravenous Glucose Infusion Rate | 6.9 mg/kg/minute | Standard Deviation 5.91 |
| Placebo | Mean Intravenous Glucose Infusion Rate | 10.4 mg/kg/minute | Standard Deviation 5.31 |
Secondary
Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute
Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no)
Time frame: Hours 36-48 after initiation of trial drug (Part 1)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dasiglucagon | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes | 9 Participants |
| Dasiglucagon | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no | 3 Participants |
| Placebo | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes | 6 Participants |
| Placebo | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no | 6 Participants |
Secondary
Time in Clinically Significant Hypoglycemia in Part 2
Percent time in clinically significant hypoglycemia (when PG was \<54 mg/dL \[or 3.0 mmol/L\]) as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Time in Clinically Significant Hypoglycemia in Part 2 | Week 1 (Days 5 to 11) | 2.07 percent time |
| Dasiglucagon | Time in Clinically Significant Hypoglycemia in Part 2 | Week 2 (Days 12 to 18) | 2.20 percent time |
| Dasiglucagon | Time in Clinically Significant Hypoglycemia in Part 2 | Week 3 (Days 19 to 25) | 0.88 percent time |
| Dasiglucagon | Time in Clinically Significant Hypoglycemia in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 1.75 percent time |
Secondary
Time in Hyperglycemia in Part 2
Percent time in hyperglycemia (when PG was \>180 mg/dL \[10.0 mmol/L\]), as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients from all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Time in Hyperglycemia in Part 2 | Week 1 (Days 5 to 11) | 1.74 percent time |
| Dasiglucagon | Time in Hyperglycemia in Part 2 | Week 2 (Days 12 to 18) | 0.81 percent time |
| Dasiglucagon | Time in Hyperglycemia in Part 2 | Week 3 (Days 19 to 25) | 0.32 percent time |
| Dasiglucagon | Time in Hyperglycemia in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 1.48 percent time |
Secondary
Time in Hypoglycemia in Part 2
Percent time in hypoglycemia (when PG was \<70 mg/dL \[or 3.9 mmol/L\]) as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Time in Hypoglycemia in Part 2 | Week 3 (Days 19 to 25) | 5.73 percent time |
| Dasiglucagon | Time in Hypoglycemia in Part 2 | Week 1 (Days 5 to 11) | 7.20 percent time |
| Dasiglucagon | Time in Hypoglycemia in Part 2 | Week 2 (Days 12 to 18) | 8.82 percent time |
| Dasiglucagon | Time in Hypoglycemia in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 6.67 percent time |
Secondary
Time in Range in Part 2
Percent time in range (PG between 70 to 180 mg/dL \[3.9-10.0 mmol/L\]) as measured by continuous glucose monitoring.
Time frame: Days 5 to 25
Population: Data were not available from all patients during all weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasiglucagon | Time in Range in Part 2 | Week 1 (Days 5 to 11) | 86.69 percent time |
| Dasiglucagon | Time in Range in Part 2 | Week 2 (Days 12 to 18) | 87.87 percent time |
| Dasiglucagon | Time in Range in Part 2 | Week 3 (Days 19 to 25) | 91.42 percent time |
| Dasiglucagon | Time in Range in Part 2 | Weeks 1 to 3 (Days 5 to 25) | 88.35 percent time |
Secondary
Time to Actual Hospital Discharge
Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital.
Time frame: Days 5 to 25
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasiglucagon | Time to Actual Hospital Discharge | NA days |
Secondary
Time to Complete Weaning Off Intravenous Glucose
Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours.
Time frame: Days 5 to 25 (Part 2)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasiglucagon | Time to Complete Weaning Off Intravenous Glucose | 5.8 days |
Secondary
Time to Pancreatic Surgery
Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%).
Time frame: Days 5 to 25
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasiglucagon | Time to Pancreatic Surgery | NA days |