A Phase 2/3 interventional study of dasiglucagon and Placebo in Congenital Hyperinsulinism, sponsored by Zealand Pharma. Completed at 6 sites in 4 countries. Open to participants aged 7 Days to 364 Days. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Zealand Pharma · Phase 2/3, Interventional, and Treatment
Among 24 studies in Congenital Hyperinsulinism with a site in United States — 3 open to participants now, 6 under way, 1 of them phase 3. Congenital Hyperinsulinism · United States.
Among the 24 studies in Congenital Hyperinsulinism with a site in United States, this one is the 13th largest by enrollment of the 20 interventional ones, is one of 2 that started in 2020, is the only one in phase 2/3, and was the 20th registered.
38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.
This study's enrollment of 12 is below the median of 17 across 30 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →3 of the 24 studies in Congenital Hyperinsulinism with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 4 Congenital Hyperinsulinism studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger; 3 take children under 18; 1 take healthy volunteers.
This study: 7 Days to 364 Days · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2020.
Median enrollment 16 across the 20 interventional studies, 30,000 across the 1 observational. Of the 16 that completed or were terminated, 9 (56%) have results posted.
7 of 24 have an industry lead sponsor. The 10 most frequent:
Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
Zealand Pharma has 3 studies filed under Congenital Hyperinsulinism — fewer than ten, so there is no comparison to draw.
2 of the studies in Congenital Hyperinsulinism with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
| NCT04205604Miguel Pampaloni18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism | 2026-12-01 |
Among the 24 studies in Congenital Hyperinsulinism with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CHI diagnosis established based on the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
48 hours of dasiglucagon subcutaneous (sc) infusion starting at 10 µg/hour with crossover to 48 hours placebo sc infusion (part 1) followed by 21 days of dasiglucagon sc infusion (part 2).
Drug: dasiglucagon · Drug: Placebo
48 hours of placebo sc infusion with crossover to 48 hours dasiglucagon sc infusion starting at 10 µg/hour (part 1) followed by 21 days of dasiglucagon sc infusion (part 2).
Drug: dasiglucagon · Drug: Placebo
Glucagon analogue
Also known as: ZP4207
Placebo for dasiglucagon
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)
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
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)
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)
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)
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
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
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
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
Carbohydrates Administered
Total amount (g) of carbohydrates administered (regardless of the route) per day.
Time frame: Days 5 to 25
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
Carbohydrates Administered Parenterally
Amount (g) of carbohydrates administered as part of total parenteral nutrition.
Time frame: Days 5 to 25
Carbohydrates Administered Orally
Amount (g) of carbohydrates administered via oral route.
Time frame: Days 5 to 25
Carbohydrates Administered Via Gastric Feed
Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy.
Time frame: Days 5 to 25
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
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
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
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
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
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
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
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
| Milestone | Dasiglucagon, Then Placebo | Placebo, Then Dasiglucagon |
|---|---|---|
| Started | 7 | 5 |
| Completed | 7 | 5 |
| Not completed | 0 | 0 |
| Milestone | Dasiglucagon, Then Placebo | Placebo, Then Dasiglucagon |
|---|---|---|
| Started | 7 | 5 |
| Completed | 7 | 5 |
| Not completed | 0 | 0 |
| Milestone | Dasiglucagon, Then Placebo | Placebo, Then Dasiglucagon |
|---|---|---|
| Started | 7 | 5 |
| Completed treatment | 7 | 4 |
| Completed | 7 | 5 |
| Not completed | 0 | 0 |
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).
| mg/kg/minute | Dasiglucagon | Placebo |
|---|---|---|
| Mean Intravenous Glucose Infusion Rate | 4.33 ± 4.922 | 9.51 ± 5.655 |
Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day.
| g/day | Dasiglucagon | Placebo |
|---|---|---|
| Carbohydrates Administered | 106.7 ± 53.72 | 139.1 ± 57.35 |
Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
| mg/kg/minute | Dasiglucagon | Placebo |
|---|---|---|
| Mean Intravenous Glucose Infusion Rate | 6.9 ± 5.91 | 10.4 ± 5.31 |
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)
| Participants | Dasiglucagon | Placebo |
|---|---|---|
| Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes | 9 | 6 |
| Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no | 3 | 6 |
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.
| days | Dasiglucagon (Part 2) |
|---|---|
| Time to Complete Weaning Off Intravenous Glucose | 5.8 (1.0 to 7.9) |
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.
| episodes per week | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 8.50 (0.0 to 29.0) |
| Week 2 (Days 12 to 18) | 6.0 (0.0 to 37.3) |
| Week 3 (Days 19 to 25) | 3.79 (0.0 to 15.2) |
| Weeks 1 to 3 (Days 5 to 25) | 6.04 (1.7 to 33.2) |
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.
| episodes per week | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 1.67 (0.0 to 11.0) |
| Week 2 (Days 12 to 18) | 1.00 (0.0 to 16.3) |
| Week 3 (Days 19 to 25) | 2.92 (0.0 to 4.0) |
| Weeks 1 to 3 (Days 5 to 25) | 1.67 (0.3 to 13.7) |
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.
| days | Dasiglucagon (Part 2) |
|---|---|
| Time to Actual Hospital Discharge | NA (11.7 to NA) |
Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%).
| days | Dasiglucagon (Part 2) |
|---|---|
| Time to Pancreatic Surgery | NA (NA to NA) |
Total amount (g) of carbohydrates administered (regardless of the route) per day.
| g/day | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 91.03 (57.6 to 190.8) |
| Week 2 (Days 12 to 18) | 75.09 (29.8 to 218.3) |
| Week 3 (Days 19 to 25) | 80.73 (0.0 to 222.1) |
| Weeks 1 to 3 (Days 5 to 25) | 87.37 (39.5 to 195.9) |
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.
| g/day | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 41.35 (3.6 to 118.8) |
| Week 2 (Days 12 to 18) | 2.12 (0.0 to 82.2) |
| Week 3 (Days 19 to 25) | 0.35 (0.0 to 119.0) |
| Weeks 1 to 3 (Days 5 to 25) | 22.60 (1.2 to 88.5) |
Amount (g) of carbohydrates administered as part of total parenteral nutrition.
No measurements were reported for this outcome.
Amount (g) of carbohydrates administered via oral route.
| g/day | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 19.57 (0.0 to 67.5) |
| Week 2 (Days 12 to 18) | 0.37 (0.0 to 88.9) |
| Week 3 (Days 19 to 25) | 0.23 (0.0 to 53.8) |
| Weeks 1 to 3 (Days 5 to 25) | 13.38 (0.0 to 63.4) |
Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy.
| g/day | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 34.43 (0.0 to 88.7) |
| Week 2 (Days 12 to 18) | 52.87 (9.0 to 92.8) |
| Week 3 (Days 19 to 25) | 57.90 (0.0 to 76.1) |
| Weeks 1 to 3 (Days 5 to 25) | 43.96 (0.0 to 85.0) |
Percent time in range (PG between 70 to 180 mg/dL \[3.9-10.0 mmol/L\]) as measured by continuous glucose monitoring.
| percent time | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 86.69 (34.5 to 94.3) |
| Week 2 (Days 12 to 18) | 87.87 (51.0 to 95.9) |
| Week 3 (Days 19 to 25) | 91.42 (36.3 to 100.0) |
| Weeks 1 to 3 (Days 5 to 25) | 88.35 (42.5 to 100.0) |
Percent time in hypoglycemia (when PG was \<70 mg/dL \[or 3.9 mmol/L\]) as measured by continuous glucose monitoring.
| percent time | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 7.20 (1.0 to 24.5) |
| Week 2 (Days 12 to 18) | 8.82 (0.6 to 49.0) |
| Week 3 (Days 19 to 25) | 5.73 (0.0 to 22.1) |
| Weeks 1 to 3 (Days 5 to 25) | 6.67 (0.0 to 30.0) |
Percent time in clinically significant hypoglycemia (when PG was \<54 mg/dL \[or 3.0 mmol/L\]) as measured by continuous glucose monitoring.
| percent time | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 2.07 (0.2 to 6.0) |
| Week 2 (Days 12 to 18) | 2.20 (0.0 to 20.4) |
| Week 3 (Days 19 to 25) | 0.88 (0.0 to 6.8) |
| Weeks 1 to 3 (Days 5 to 25) | 1.75 (0.0 to 9.2) |
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.
| episodes per week | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 25.00 (3.0 to 58.0) |
| Week 2 (Days 12 to 18) | 26.50 (3.0 to 74.7) |
| Week 3 (Days 19 to 25) | 18.63 (0.0 to 58.3) |
| Weeks 1 to 3 (Days 5 to 25) | 18.54 (0.0 to 66.3) |
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.
| episodes per week | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 5.00 (1.0 to 23.0) |
| Week 2 (Days 12 to 18) | 8.50 (0.0 to 46.7) |
| Week 3 (Days 19 to 25) | 2.67 (0.0 to 18.7) |
| Weeks 1 to 3 (Days 5 to 25) | 5.00 (0.0 to 34.8) |
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.
| mg/dL/hour | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 0.87 (0.1 to 2.7) |
| Week 2 (Days 12 to 18) | 0.97 (0.0 to 8.9) |
| Week 3 (Days 19 to 25) | 0.59 (0.1 to 2.6) |
| Weeks 1 to 3 (Days 5 to 25) | 0.89 (0.1 to 4.3) |
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.
| mg/dL/hour | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 0.14 (0.0 to 0.4) |
| Week 2 (Days 12 to 18) | 0.13 (0.0 to 2.1) |
| Week 3 (Days 19 to 25) | 0.12 (0.0 to 0.4) |
| Weeks 1 to 3 (Days 5 to 25) | 0.14 (0.0 to 0.8) |
Percent time in hyperglycemia (when PG was \>180 mg/dL \[10.0 mmol/L\]), as measured by continuous glucose monitoring.
| percent time | Dasiglucagon (Part 2) |
|---|---|
| Week 1 (Days 5 to 11) | 1.74 (0.0 to 64.5) |
| Week 2 (Days 12 to 18) | 0.81 (0.0 to 45.0) |
| Week 3 (Days 19 to 25) | 0.32 (0.0 to 62.7) |
| Weeks 1 to 3 (Days 5 to 25) | 1.48 (0.0 to 56.6) |
Collected over Treatment-emergent adverse events are reported here, and were recorded from the time of first administration of study treatment until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 8 weeks, from Day 1 through Day 56).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Dasiglucagon | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Part 1: Placebo | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Part 2: Dasiglucagon | 0/12 (0%) | 1/12 (8.3%) | 10/12 (83.3%) |
| Parts 1 and 2: Dasiglucagon | 0/12 (0%) | 1/12 (8.3%) | 10/12 (83.3%) |
| Follow-up Period | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Part 1: Dasiglucagon | Part 1: Placebo | Part 2: Dasiglucagon | Parts 1 and 2: Dasiglucagon | Follow-up Period |
|---|---|---|---|---|---|
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/12 | 0/12 | 1/12 | 1/12 | 0/1 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/12 | 0/12 | 1/12 | 1/12 | 0/1 |
| Event | Part 1: Dasiglucagon | Part 1: Placebo | Part 2: Dasiglucagon | Parts 1 and 2: Dasiglucagon | Follow-up Period |
|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 0/12 | 0/12 | 2/12 | 2/12 | 1/1 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/12 | 0/12 | 0/12 | 0/12 | 1/1 |
| VomitingGastrointestinal disorders | 1/12 | 1/12 | 2/12 | 3/12 | 0/1 |
| Rash PapularSkin and subcutaneous tissue disorders | 0/12 | 0/12 | 3/12 | 3/12 | 0/1 |
| AnaemiaBlood and lymphatic system disorders | 0/12 | 0/12 | 3/12 | 3/12 | 0/1 |
| Gastrooesophageal Reflux DiseaseGastrointestinal disorders | 0/12 | 0/12 | 2/12 | 2/12 | 0/1 |
| Aspartate Aminotransferase IncreasedInvestigations | 1/12 | 1/12 | 2/12 | 2/12 | 0/1 |
| Alanine Aminotransferase IncreasedInvestigations | 1/12 | 1/12 | 1/12 | 2/12 | 0/1 |
| Dermatitis DiaperSkin and subcutaneous tissue disorders | 0/12 | 0/12 | 2/12 | 2/12 | 0/1 |
| HypokalaemiaMetabolism and nutrition disorders | 0/12 | 1/12 | 2/12 | 2/12 | 0/1 |
| Age, Categorical(Participants) | All Participants Who Received Treatment |
|---|---|
| <=18 years | 12 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(Days) | All Participants Who Received Treatment |
|---|---|
| Mean | 71.25 ± 84.976 |
| Sex: Female, Male(Participants) | All Participants Who Received Treatment |
|---|---|
| Female | 2 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | All Participants Who Received Treatment |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | All Participants Who Received Treatment |
|---|---|
| Race — Asian | 2 |
| Race — White | 8 |
| Race — Other | 2 |
| Region of Enrollment(participants) | All Participants Who Received Treatment |
|---|---|
| United States | 8 |
| United Kingdom | 3 |
| Germany | 1 |
| Gastrostomy/nasogastric tube(Participants) | All Participants Who Received Treatment |
|---|---|
| Gastrostomy | 2 |
| Nasogastric tube | 7 |
| None | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2020 to primary completion in Feb 2022, 19 months.
Results were first posted in Mar 2025, 3 years after primary completion. A results delay was requested in Mar 2023.
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Studies of the drug tested here: Dasiglucagon