Primary outcomeCount of participants· Baseline through Study Completion (Day 23)
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
| Group | Value (Participants) |
|---|---|
| NG 0.5 mg | 0 |
| NG 1 mg | 0 |
| NG 2 mg | 0 |
| SC Glucagon 1 mg | 0 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataA Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
NCTNCT02778113 (opens ClinicalTrials.gov in a new tab)Other id16424Other idI8R-MC-IGBDOther idAMG 101Other idGUO-P1-557
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 16 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Single masking
- Countries
1 country
Canada
- Start
- Oct 2011
- Primary completion
- Oct 2011
- Completion
- Nov 2011
- First posted
- 19 May 2016 (estimated)
- Last update posted
- 19 Sept 2019
- Conditions
- Healthy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20112012
- Ph 1
A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
NCT02778113Oct 2011 to Nov 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.
Interventions
- Nasal GlucagonDrug
- GlucagonDrug
Arms4
Experimental
Nasal Glucagon (NG) - 0.5 mg
Ng dose at 0.5 milligram (mg) administered once in one of four study periods.
Experimental
NG - 1.0 mg
Ng dose at 1.0 milligram (mg) administered once in one of four study periods.
Experimental
NG - 2.0 mg
Ng dose at 2.0 milligram (mg) administered once in one of four study periods.
Active comparator
SC Glucagon 1 mg
Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Time frame · Baseline through Study Completion (Day 23)
Registry description
Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary outcomes(7)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeGeometric mean· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
| Group | Value (picogram*hour per milliliter (pg*h/mL)) | Spread |
|---|---|---|
| NG 0.5 mg | NA | NA |
| NG 1 mg | 38.9 | 483 |
| NG 2 mg | 293 | 172 |
| SC Glucagon 1 mg | 2060 | 68 |
Secondary outcomeGeometric mean· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
| Group | Value (pg*h/mL) | Spread |
|---|---|---|
| NG 0.5 mg | not posted | – |
| NG 1 mg | NA | NA |
| NG 2 mg | 589 | 50 |
| SC Glucagon 1 mg | 2250 | 66 |
Secondary outcomeMedian· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
| Group | Value (hour (h)) |
|---|---|
| NG 0.5 mg | 0.17 |
| NG 1 mg | 0.25 |
| NG 2 mg | 0.25 |
| SC Glucagon 1 mg | 0.33 |
Secondary outcomeGeometric mean· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
| Group | Value (picogram per milliliter (pg/mL)) | Spread |
|---|---|---|
| NG 0.5 mg | NA | NA |
| NG 1 mg | 217 | 231 |
| NG 2 mg | 1000 | 104 |
| SC Glucagon 1 mg | 3260 | 59 |
Secondary outcomeMean· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose
| Group | Value (millimole*hour per liter (mmol*h/L)) | Spread |
|---|---|---|
| NG 0.5 mg | -0.168 | 0.202 |
| NG 1 mg | 0.0617 | 0.177 |
| NG 2 mg | 0.566 | 0.324 |
| SC Glucagon 1 mg | 0.448 | 0.490 |
Secondary outcomeMedian· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
| Group | Value (hour (h)) |
|---|---|
| NG 0.5 mg | 0.33 |
| NG 1 mg | 0.36 |
| NG 2 mg | 0.50 |
| SC Glucagon 1 mg | 0.37 |
Secondary outcomeMean· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
| Group | Value (millimole per liter (mmol/L)) | Spread |
|---|---|---|
| NG 0.5 mg | 0.811 | 0.119 |
| NG 1 mg | 1.92 | 0.173 |
| NG 2 mg | 3.20 | 0.252 |
| SC Glucagon 1 mg | 3.28 | 0.326 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| NG 0.5 mgNG dose of 0.5 mg. | – | 0 / 15 | 2 / 15 |
| NG 1 mgNG dose of 1 mg. | – | 0 / 14 | 6 / 14 |
| NG 2 mgNG dose of 2 mg. | – | 0 / 16 | 8 / 16 |
| SC Glucagon 1 mgSC glucagon dose of 1 mg. | – | 0 / 15 | 6 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
* Light-, non- or ex-smokers.
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).
Exclusion Criteria:
* Presence of any nose piercings.
* History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
* Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.
* Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following a 12-hour fasting period.
* Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before each dosing.
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