Trial · NCT02171130
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
NCT02171130, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-10-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia. Trials, record NCT02171130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02171130
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
- NCT number
- NCT02171130
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 129 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
- Interventions
- Nasal Glucagon
- First posted
- 2014-06-24
- Last updated
- 2019-10-15
- Results first posted
- 2019-10-15
- Limitations and caveats
Sixteen participants were discontinued early because of a clinical trial material issue which might have led to under-dose. One site was terminated due to GCP non-compliance and five participants were discontinued as a result.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration | Within 30 minutes after each drug administration for an episode of hypoglycemia | Responses to questions completed by the caregiver were used to assess this outcome. An episode of severe hypoglycemia was defined as an episode wherein the person with diabetes is clinically incapacitated to the point where the person requires third-party assistance to treat the hypoglycemia. An episode of moderate hypoglycemia episode was defined as an episode wherein the person with diabetes was showing signs of neuroglycopenia and had a glucometer reading of approximately 60 milligrams per deciliter (mg/dL) (3.3 millimoles per liter \[mmol/L\]) or less based on a blood sample taken at or near the time of treatment. |
| Secondary | Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | After each drug administration for an episode of hypoglycemia | Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Nasal Glucagon is easy to carry and would be willing to carry it, nasal delivery of glucagon is preferable. Level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree). |
| Secondary | Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire | Within 2 hours of full recovery from a hypoglycemic event | Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other. A summary of other nonserious AEs, and all Serious Adverse Events (SAEs), regardless of causality, is located in the Reported Adverse Events section. |
| Other | Blood Glucose Levels Over Time | Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia | The participants' blood glucose level was measured by the caregiver using a glucometer at baseline (just prior to dosing and right after the study drug administration), 15, 30 and 45 minutes after nasal glucagon administration. |
| Other | Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA) | Baseline and End of Study (6 months) | Treatment-Emergent ADA includes treatment-induced ADA ('Not Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer of (1:20) and treatment-boosted ADA (with 'Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer that is at least 4-fold higher than the baseline titer. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration | Within 30 minutes after each drug administration for an episode of hypoglycemia | Enrolled participants received at least 1 dose of the study drug with evaluable hypoglycemic event. Events requiring additional medical assistance or rescue therapy within 30 minutes of study drug administration and participants from a Good Clinical Practice (GCP) non-compliant site were excluded. | percentage of participants | NUMBER |
| SECONDARY | Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | After each drug administration for an episode of hypoglycemia | Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug. Participants from the GCP non-compliant site and participants who were impacted by a clinical material issue which might have led to under-dose, were considered ineligible thus excluded from this population. | Total Number of Events | COUNT_OF_UNITS |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire | Within 2 hours of full recovery from a hypoglycemic event | Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Blood Glucose Levels Over Time | Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia | Enrolled participants received at least 1 dose of the study drug with evaluable hypoglycemic event. Events requiring additional medical assistance or rescue therapy within 30 minutes of study drug administration and participants from a GCP non-compliant site were excluded. | milligram/deciliter (mg/dL) | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA) | Baseline and End of Study (6 months) | Enrolled participants who had antibody sample at both baseline and post-baseline. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration | Nasal Glucagon | 95.7 | percentage of participants | ||
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: opening the kit (Very Difficult) | 2 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: opening the kit (Average) | 4 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: opening the kit (Relatively Easy) | 4 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: opening the kit (Easy) | 26 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: opening the kit (Very Easy) | 143 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: instructions (Very Difficult) | 2 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: instructions (Average) | 4 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: instructions (Relatively Easy) | 10 | Total Number of Events | |
| Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver | Nasal Glucagon | Difficulty: instructions (Easy) | 36 | Total Number of Events |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nasal Glucagon (NG) | 129 | |
| Overall Study | Received at Least One Dose of Study Drug | Nasal Glucagon (NG) | 87 | |
| Overall Study | Experienced Hypoglycemic Event | Nasal Glucagon (NG) | 87 | |
| Overall Study | COMPLETED | Nasal Glucagon (NG) | 101 | |
| Overall Study | NOT COMPLETED | Nasal Glucagon (NG) | 28 |
Source ClinicalTrials.gov
Adverse events29
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Nasal Glucagon | 5 | 87 | 6 |
| other | Eye inflammation | Eye disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Eye pain | Eye disorders | Nasal Glucagon | 2 | 87 | 3 |
| other | Hypoaesthesia eye | Eye disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Lacrimation increased | Eye disorders | Nasal Glucagon | 8 | 87 | 10 |
| other | Asthenia | General disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Facial pain | General disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Feeling abnormal | General disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Pain | General disorders | Nasal Glucagon | 1 | 87 | 1 |
| other | Product taste abnormal | General disorders | Nasal Glucagon | 3 | 87 | 3 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nasal Glucagon | 1 | 87 |
| Total, other adverse events | Nasal Glucagon | 74 | 87 |
| Total, serious adverse events | Nasal Glucagon | 1 | 87 |
Source ClinicalTrials.gov
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/NCT02171130
GET https://conductscience.org/api/trials/v1/NCT02171130/results?page=2