Trial · NCT03941236
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT03941236, Phase 3, Completed, Zealand Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism. Trials, record NCT03941236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03941236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
- NCT number
- NCT03941236
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Zealand Pharma
- Conditions
- Congenital Hyperinsulinism
- Interventions
- dasiglucagon
- First posted
- 2019-05-07
- Last updated
- 2026-08-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Baseline through treatment completion, up to 3 years | Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis |
| Secondary | Amount of gastric carbohydrates administered to treat hypoglycemia | Baseline through treatment completion, up to 3 years | Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia |
| Secondary | Nasogastric (NG) tube or gastrostomy removal | Baseline through treatment completion, up to 3 years | Time to removal of NG tube or gastrostomy |
| Secondary | Pancreatic surgery | Baseline through treatment completion, up to 3 years | Time to pancreatic surgery (sub-total or total pancreatectomy) |
| Secondary | Time in hypoglycemia | Baseline through treatment completion, up to 3 years | Continuous glucose monitoring (CGM) percent time \<70 mg/dL (3.9 mmol/L) |
| Secondary | Hypoglycemia episodes | Baseline through treatment completion, up to 3 years | Rate of CGM-detected hypoglycemia episodes \<70 mg/dL (3.9 mmol/L) for 15 minutes or more |
| Secondary | Clinically significant episodes of hypoglycemia | Baseline through treatment completion, up to 3 years | Rate of clinically significant CGM-detected hypoglycemia episodes \<54 mg/dL (3.0 mmol/L) for 15 minutes or more |
| Secondary | Gastric carbohydrate administrations | Baseline through treatment completion, up to 3 years | Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia |
| Secondary | Nightly gastric carbohydrate administrations | Baseline through treatment completion, up to 3 years | Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia |
| Secondary | Extent of hypoglycemia | Baseline through treatment completion, up to 3 years | Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continous glucose monitoring (CGM) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03941236
GET https://conductscience.org/api/trials/v1/NCT03941236/registered