A Phase 3 interventional study of Dasiglucagon and Standard of Care in Congenital Hyperinsulinism, sponsored by Zealand Pharma. Completed at 10 sites in 4 countries. Open to participants aged 3 Months to 12 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Zealand Pharma · Phase 3, Interventional, and Treatment
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.
This study's enrollment of 32 is above the median of 17 across 30 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →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.
Counted across the registry records on this site, refreshed daily.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care
Drug: Dasiglucagon · Other: Standard of Care
4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care
Drug: Dasiglucagon · Other: Standard of Care
Glucagon analog
Also known as: ZP4207
Standard of care according to site and/or country
Hypoglycemia Episode Rate
Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Increase in Fasting Tolerance
Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continuous glucose monitoring reading \<70 mg/dL \[3.9 mmol/L\]), or the time the test ended if a continuous 15-minute CGM reading \<70 mg/dL was not reached. The change from Baseline to the End of Treatment Period 1 (Week 4) is also provided. The Baseline value is the value recorded at the Screening visit.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Percent Time in Range 70-180 mg/dL
Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4 as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent time in range 70-180 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value was calculated as the average percent time in range during the 14 days before randomization.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Clinically Significant Hypoglycemia Episode Rates
Clinically significant hypoglycemia episode rates during Weeks 2-4, defined as average weekly number of clinically significant hypoglycemic episodes (PG \<54 mg/dL \[3.0 mmol/L\]), as detected by SMPG. The Week 2-4 value is the average weekly clinically significant hypoglycemia episode rate across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of clinically significant hypoglycemic episodes during the 2-week baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia
Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia. The Week 2-4 value is the average weekly total amount of gastric carbohydrates across the last 3 weeks of treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia
Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 2-4 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Extent of Hypoglycemia
Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) and below 54 mg/dL \[3.0 mmol/L\] as measured by continuous glucose monitoring. The extent of hypoglycemia was defined as the AOCglucose under the threshold divided by total duration in hours of CGM measurement. A reduction in this measure indicates a benefit. The Week 2-4 value is the average weekly extent of hypoglycemia below 70 mg/dL and below 54 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Amount of Nightly Gastric Carbohydrates Administered
Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week. The change from Baseline is also provided for each week. The Baseline value is the value recorded during the 2-week Baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Total Amount of Gastric Carbohydrates Administered
Total amount of gastric carbohydrates administered (regardless of whether this was to treat hypoglycemia or not) via nasogastric tube or gastrostomy per week. The Week 2-4 value is the average amount of gastric carbohydrates administered via nasogastric tube or gastrostomy across the last 3 weeks of the treatment period. The change from baseline to Week 2-4 is also provided. The baseline value is the value recorded during the 2-week baseline period.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Percent Time in Hypoglycemia
Percent time in hypoglycemia (PG \<70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Rate of Hypoglycemic Episodes
Rate of hypoglycemic episodes, defined as number of episodes with PG \<70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 14 days before randomization.
Time frame: Baseline, Week 2-4 (Treatment Period 1)
Percent Time in Hypoglycemia in Treatment Period 2
Percent time in hypoglycemia (PG \<70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring. The Week 6-8 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
Time frame: Baseline, Week 6-8 (Treatment Period 2)
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2
Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 6-8 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
Time frame: Baseline, Week 6-8 (Treatment Period 2)
Rate of Hypoglycemic Episodes in Treatment Period 2
Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) as detected by SMPG. The Week 6-8 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.
Time frame: Baseline, Week 6-8 (Treatment Period 2)
Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2
Change from Baseline to Week 6-8 in the clinically significant (CS) hypoglycemia episode rate in treatment period 2, defined as the average weekly number of episodes \<54 mg/dL (3.0 mmol/L), for 15 minutes or more, as measured by continuous glucose monitoring (CGM). The Week 6-8 value is the average weekly CS hypoglycemia episode rate across the last 3 weeks of the treatment period. The Baseline value is the average weekly number of CS hypoglycemic episodes during the 14 days before randomization.
Time frame: Baseline, Week 6-8 (Treatment Period 2)
| Milestone | Standard of Care + Dasiglucagon (Treatment Period 1) | Standard of Care Only (Treatment Period 1) | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|---|---|
| Started | 16 | 16 | 0 |
| Completed | 16 | 16 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Standard of Care + Dasiglucagon (Treatment Period 1) | Standard of Care Only (Treatment Period 1) | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|---|---|
| Started | 0 | 0 | 32 |
| Completed study but discontinued treatment due to an ae | 0 | 0 | 1 |
| Completed | 0 | 0 | 32 |
| Not completed | 0 | 0 | 0 |
Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.
| episodes per week | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Weekly number of episodes in Weeks 2-4 | 5.29 ± 5.256 | 5.85 ± 2.767 |
| Change from Baseline | -3.05 ± 4.343 | -3.15 ± 4.753 |
Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continuous glucose monitoring reading \<70 mg/dL \[3.9 mmol/L\]), or the time the test ended if a continuous 15-minute CGM reading \<70 mg/dL was not reached. The change from Baseline to the End of Treatment Period 1 (Week 4) is also provided. The Baseline value is the value recorded at the Screening visit.
| hours | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| End of Treatment Period 1 | 6.13 ± 5.335 | 4.22 ± 4.222 |
| Change from Baseline | 1.20 ± 5.908 | 1.27 ± 3.836 |
Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4 as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent time in range 70-180 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value was calculated as the average percent time in range during the 14 days before randomization.
| percent time | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 75.10 ± 11.821 | 72.65 ± 7.313 |
| Change from Baseline | -0.97 ± 11.837 | 2.44 ± 9.584 |
Clinically significant hypoglycemia episode rates during Weeks 2-4, defined as average weekly number of clinically significant hypoglycemic episodes (PG \<54 mg/dL \[3.0 mmol/L\]), as detected by SMPG. The Week 2-4 value is the average weekly clinically significant hypoglycemia episode rate across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of clinically significant hypoglycemic episodes during the 2-week baseline period.
| episodes per week | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Weekly number of episodes in Weeks 2-4 | 1.77 ± 1.857 | 1.90 ± 1.407 |
| Change from Baseline | -0.51 ± 2.798 | -0.35 ± 1.446 |
Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia. The Week 2-4 value is the average weekly total amount of gastric carbohydrates across the last 3 weeks of treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
| grams | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 22.89 ± 31.415 | 37.66 ± 57.998 |
| Change from Baseline | -33.66 ± 82.767 | -19.74 ± 64.082 |
Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 2-4 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
| number of administrations per week | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 2.30 ± 3.433 | 2.18 ± 2.714 |
| Change from Baseline | -0.29 ± 4.920 | -2.13 ± 3.825 |
Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) and below 54 mg/dL \[3.0 mmol/L\] as measured by continuous glucose monitoring. The extent of hypoglycemia was defined as the AOCglucose under the threshold divided by total duration in hours of CGM measurement. A reduction in this measure indicates a benefit. The Week 2-4 value is the average weekly extent of hypoglycemia below 70 mg/dL and below 54 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
| mmol/L | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4: Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L) | 0.083 ± 0.0618 | 0.147 ± 0.0736 |
| Change from Baseline in Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L) | -0.062 ± 0.1003 | -0.019 ± 0.0959 |
| Week 2-4: Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L) | 0.015 ± 0.0117 | 0.025 ± 0.0132 |
| Change from Baseline in Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L) | -0.008 ± 0.0252 | -0.007 ± 0.0252 |
Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week. The change from Baseline is also provided for each week. The Baseline value is the value recorded during the 2-week Baseline period.
| grams | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 1 | 95.98 ± 153.272 | 33.43 ± 90.955 |
| Change from Baseline at Week 1 | 41.64 ± 63.484 | 3.64 ± 27.29 |
| Week 2 | 77.24 ± 147.065 | 39.25 ± 100.638 |
| Change from Baseline at Week 2 | 22.90 ± 137.325 | 9.46 ± 40.853 |
| Week 3 | 67.59 ± 141.062 | 30.31 ± 94.870 |
| Change from Baseline at Week 3 | 13.24 ± 148.569 | 0.52 ± 25.022 |
| Week 4 | 63.89 ± 127.849 | 34.62 ± 94.549 |
| Change from Baseline at Week 4 | 9.55 ± 134.369 | 4.83 ± 25.689 |
Total amount of gastric carbohydrates administered (regardless of whether this was to treat hypoglycemia or not) via nasogastric tube or gastrostomy per week. The Week 2-4 value is the average amount of gastric carbohydrates administered via nasogastric tube or gastrostomy across the last 3 weeks of the treatment period. The change from baseline to Week 2-4 is also provided. The baseline value is the value recorded during the 2-week baseline period.
| grams | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 567.35 ± 453.373 | 775.96 ± 551.640 |
| Change from Baseline | -146.56 ± 222.995 | 160.44 ± 438.735 |
Percent time in hypoglycemia (PG \<70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
| percent time | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 11.77 ± 9.248 | 20.22 ± 10.034 |
| Change from Baseline | -9.91 ± 10.119 | -1.95 ± 10.186 |
Rate of hypoglycemic episodes, defined as number of episodes with PG \<70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 14 days before randomization.
| episodes per week | Standard of Care + Dasiglucagon | Standard of Care Only |
|---|---|---|
| Week 2-4 | 21.71 ± 14.179 | 36.88 ± 15.023 |
| Change from Baseline | -14.37 ± 21.184 | -6.28 ± 20.565 |
Percent time in hypoglycemia (PG \<70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring. The Week 6-8 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value assessed during the 14 days before randomization.
| percent time | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|
| Week 6-8 | 8.64 ± 6.011 |
| Change from Baseline | -13.27 ± 10.120 |
Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 6-8 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.
| number of administrations per week | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|
| Week 6-8 | 1.31 ± 2.254 |
| Change from Baseline | -2.22 ± 4.990 |
Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) as detected by SMPG. The Week 6-8 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.
| episodes per week | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|
| Weekly number of episodes in Weeks 6-8 | 3.06 ± 2.730 |
| Change from Baseline | -5.61 ± 4.096 |
Change from Baseline to Week 6-8 in the clinically significant (CS) hypoglycemia episode rate in treatment period 2, defined as the average weekly number of episodes \<54 mg/dL (3.0 mmol/L), for 15 minutes or more, as measured by continuous glucose monitoring (CGM). The Week 6-8 value is the average weekly CS hypoglycemia episode rate across the last 3 weeks of the treatment period. The Baseline value is the average weekly number of CS hypoglycemic episodes during the 14 days before randomization.
| episodes per week | Standard of Care + Dasiglucagon (Treatment Period 2) |
|---|---|
| Week 6-8 | 7.78 ± 5.226 |
| Change from Baseline | -8.51 ± 9.941 |
Collected over Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Period 1: Standard of Care + Dasiglucagon | 0/16 (0%) | 2/16 (12.5%) | 14/16 (87.5%) |
| Treatment Period 1: Standard of Care Only | 0/16 (0%) | 1/16 (6.3%) | 8/16 (50%) |
| Treatment Period 2: Standard of Care + Dasiglucagon | 0/32 (0%) | 2/32 (6.3%) | 24/32 (75%) |
| Event | Treatment Period 1: Standard of Care + Dasiglucagon | Treatment Period 1: Standard of Care Only | Treatment Period 2: Standard of Care + Dasiglucagon |
|---|---|---|---|
| Localised InfectionInfections and infestations | 1/16 | 0/16 | 0/32 |
| Vascular Device InfectionInfections and infestations | 1/16 | 0/16 | 0/32 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/16 | 1/16 | 0/32 |
| FolliculitisInfections and infestations | 0/16 | 0/16 | 1/32 |
| H1N1 InfluenzaInfections and infestations | 0/16 | 0/16 | 1/32 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/16 | 0/16 | 1/32 |
| Event | Treatment Period 1: Standard of Care + Dasiglucagon | Treatment Period 1: Standard of Care Only | Treatment Period 2: Standard of Care + Dasiglucagon |
|---|---|---|---|
| EczemaSkin and subcutaneous tissue disorders | 5/16 | 0/16 | 1/32 |
| VomitingGastrointestinal disorders | 5/16 | 1/16 | 2/32 |
| RashSkin and subcutaneous tissue disorders | 3/16 | 0/16 | 2/32 |
| Upper Respiratory Tract InfectionInfections and infestations | 2/16 | 0/16 | 2/32 |
| DiarrhoeaGastrointestinal disorders | 2/16 | 1/16 | 0/32 |
| TeethingGastrointestinal disorders | 2/16 | 0/16 | 0/32 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/16 | 0/16 | 4/32 |
| Eczema InfectedInfections and infestations | 0/16 | 0/16 | 3/32 |
| Localised InfectionInfections and infestations | 0/16 | 1/16 | 0/32 |
| FolliculitisInfections and infestations | 1/16 | 0/16 | 0/32 |
| Age, Continuous(years) | Standard of Care + Dasiglucagon | Standard of Care Only | Total |
|---|---|---|---|
| Mean | 3.55 ± 2.592 | 5.00 ± 2.892 | 4.27 ± 2.800 |
| Sex: Female, Male(Participants) | Standard of Care + Dasiglucagon | Standard of Care Only | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 10 | 6 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Standard of Care + Dasiglucagon | Standard of Care Only | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 4 |
| Not Hispanic or Latino | 12 | 16 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard of Care + Dasiglucagon | Standard of Care Only | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
| United Kingdom | 6 | 3 | 9 |
| Israel | 0 | 3 | 3 |
| Germany | 3 | 3 | 6 |
| Gastrostomy/nasogastric tube(Participants) | Standard of Care + Dasiglucagon | Standard of Care Only | Total |
|---|---|---|---|
| Gastrostomy | 9 | 12 | 21 |
| Nasogastric tube | 2 | 1 | 3 |
| None | 5 | 3 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Aug 2020, 18 months.
Results were first posted in Dec 2023, 3 years 3 months after primary completion. A results delay was requested in Sep 2021.
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Studies of the drug tested here: Dasiglucagon