Trial · NCT04172441
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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). |
| Secondary | 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) |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Time to Pancreatic Surgery | Days 5 to 25 | Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%). |
| Secondary | Carbohydrates Administered | Days 5 to 25 | Total amount (g) of carbohydrates administered (regardless of the route) per day. |
| Secondary | 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. |
| Secondary | Carbohydrates Administered Parenterally | Days 5 to 25 | Amount (g) of carbohydrates administered as part of total parenteral nutrition. |
| Secondary | Carbohydrates Administered Orally | Days 5 to 25 | Amount (g) of carbohydrates administered via oral route. |
| Secondary | Carbohydrates Administered Via Gastric Feed | Days 5 to 25 | Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04172441/registered