Trial · NCT03439072
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With a Positive Glucose Response | 0 to 30 minutes post dose | Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Time for Positive Glucose Response | 0 to 180 minutes post dose | Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL |
| Secondary | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase | 0 to 30 minutes post dose | A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Number of Subjects With a Positive Glucose Increase | 0 to 30 minutes post dose | Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon |
| Secondary | Time for Positive Glucose Increase | 0 to 180 minutes post dose | Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline |
| Secondary | Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Number of Subjects With Relief of Neuroglycopenic Symptoms | 0 to 30 minutes post dose | Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Time to Resolution of Autonomic Symptoms | 0 to 180 minutes post dose | Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness. |
| Secondary | Time to Resolution of Neuroglycopenic Symptoms | 0 to 180 minutes post dose | Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness. |
| Secondary | Time to Resolution of the Feeling of Hypoglycemia | 0 to 180 minutes post dose | Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, "Do you feel hypoglycemic?" The time point as which the subject first answered "no" was considered the time of resolution. |
| Secondary | Glucose AUC | 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose. | Area under the curve for plasma glucose. |
| Secondary | Glucose Cmax | 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose. | Maximum concentration of plasma glucose. |
| Secondary | Glucose Tmax | 0 to 180 minutes post dose | Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose. |
| Secondary | Glucagon Preparation and Administration Time | 0 to 5 minutes pre-dose | Time required to prepare and inject glucagon as measured between a "decision to dose" and completion of the injection |
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
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GET https://conductscience.org/api/trials/v1/NCT03439072/registered