A Phase 2 interventional study of Nasal Glucagon 1 mg and Nasal Glucagon 2 mg in Hypoglycemia, sponsored by Eli Lilly and Company. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.
The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.
In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's enrollment of 18 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nasal glucagon (NG) administered as single dose of 1 milligram (mg).
Drug: Nasal Glucagon 1 mg
NG administered as single dose of 2 mg.
Drug: Nasal Glucagon 2 mg
Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.
Drug: SC Glucagon
NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).
Drug: Nasal Glucagon 3 mg
Also known as: Dry Powder Nasal Glucagon, AMG504-1, LY900018
Also known as: Dry Powder Nasal Glucagon, AMG504-1, LY900018
Also known as: Glucagon, Glucagon for injection (rDNA origin)
Also known as: Dry Powder Nasal Glucagon, AMG504-1, LY900018
Percentage of Responders
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
Time frame: Pre-dose; 30 minutes following glucagon administration
Number of Participants With at Least One Adverse Event
Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Within 3 hours post glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time frame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Participants were recruited from the clinical site's database and from participants who responded to advertising in local media.
| Milestone | Treatment Group 1 | Treatment Group 2 | Treatment Group 3 |
|---|---|---|---|
| Started | 10 | 2 | 6 |
| Completed | 10 | 2 | 6 |
| Not completed | 0 | 0 | 0 |
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
| percentage of participants | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Percentage of Responders | 83.3 | 25 | 50 | 75 |
Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Participants | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Number of Participants With at Least One Adverse Event | 16 | 9 | 15 | 8 |
| millimole per liter (mmol/L) | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Maximum Concentration (Cmax) of Baseline-Adjusted Glucose | 5.68 ± 2.57 | 2.41 ± 1.89 | 3.46 ± 1.44 | 3.11 ± 2.08 |
| hours (hr) | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | 1.5 (0.5 to 3.0) | 0.67 (0.08 to 3.0) | 1.0 (0.5 to 3.0) | 1.0 (0.5 to 3.0) |
| picograms per millilitre (pg/mL) | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Maximum Change From Baseline Concentration (Cmax) of Glucagon | 3930 ± 2650 | 504 ± 342 | 2370 ± 1810 | 1360 ± 722 |
| hours (hr) | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | 0.33 (0.08 to 0.67) | 0.25 (0.17 to 0.25) | 0.33 (0.17 to 0.50) | 0.29 (0.17 to 0.50) |
| hour*picogram per millilitre (hr*pg/mL) | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon | 2390 ± 1350 | 95.2 ± 38.4 | 886 ± 796 | 720 ± 386 |
Collected over First dose of study drug (Day 1) until post-study completion (Day 38). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SC Glucagon | — | 0/18 (0%) | 16/18 (88.9%) |
| NG 1 mg | — | 0/12 (0%) | 9/12 (75%) |
| NG 2 mg | — | 0/18 (0%) | 15/18 (83.3%) |
| NG 3 mg | — | 0/8 (0%) | 8/8 (100%) |
| Event | SC Glucagon | NG 1 mg | NG 2 mg | NG 3 mg |
|---|---|---|---|---|
| Lacrimation IncreasedEye disorders | 1/18 | 1/12 | 9/18 | 6/8 |
| NauseaGastrointestinal disorders | 7/18 | 1/12 | 3/18 | 0/8 |
| HeadacheNervous system disorders | 3/18 | 1/12 | 6/18 | 0/8 |
| VomitingGastrointestinal disorders | 5/18 | 0/12 | 0/18 | 0/8 |
| AstheniaGeneral disorders | 2/18 | 2/12 | 5/18 | 1/8 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/18 | 1/12 | 5/18 | 0/8 |
| PallorVascular disorders | 4/18 | 0/12 | 2/18 | 2/8 |
| TremorNervous system disorders | 0/18 | 0/12 | 2/18 | 2/8 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 1/18 | 3/12 | 1/18 | 0/8 |
| DizzinessNervous system disorders | 0/18 | 1/12 | 4/18 | 1/8 |
All enrolled participants.
| Age, Categorical(Participants) | Treatment Group 1 | Treatment Group 2 | Treatment Group 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 2 | 6 | 18 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment Group 1 | Treatment Group 2 | Treatment Group 3 | Total |
|---|---|---|---|---|
| Mean | 34 ± 14 | 42 ± 2 | 25 ± 6 | 32 ± 12 |
| Sex: Female, Male(Participants) | Treatment Group 1 | Treatment Group 2 | Treatment Group 3 | Total |
|---|---|---|---|---|
| Female | 4 | 0 | 1 | 5 |
| Male | 6 | 2 | 5 | 13 |
| Region of Enrollment(Participants) | Treatment Group 1 | Treatment Group 2 | Treatment Group 3 | Total |
|---|---|---|---|---|
| Canada | 10 | 2 | 6 | 18 |
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company