A Phase 1 interventional study of Nasal Glucagon and Intramuscular Glucagon in Hypoglycemia and Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 2 sites in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
Among 32 studies testing glucagon in Hypoglycemia — 1 open to participants now, 2 under way, none of them phase 3. Glucagon · Hypoglycemia.
Among the 32 studies testing glucagon in Hypoglycemia, this one is the 7th largest by enrollment of the 31 interventional ones, is one of 4 that started in 2017, is one of 5 in phase 1, and was the 22nd registered.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 70 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →1 of the 32 studies testing glucagon in Hypoglycemia is open now, in 1 country. Each count lists the studies.
Glucagon: first FDA approval 1960 (GLUCAGON), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 59 Hypoglycemia studies recruiting now, 23 (39%) set no upper age limit and 31 (53%) stop at 75 or younger; 18 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2017.
Median enrollment 18 across the 31 interventional studies. Of the 27 that completed or were terminated, 19 (70%) have results posted.
18 of 32 have an industry lead sponsor. The 10 most frequent:
Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
10 studies in Hypoglycemia by Eli Lilly and Company: none open now, 1 under way, none of them phase 3. Of 9 finished, 9 (100%) have results posted.
Among the 10 studies in Hypoglycemia by Eli Lilly and Company, this one is the only one that started in 2017, is one of 4 in phase 1, and was the 6th registered.
Eli Lilly and Company’s Hypoglycemia studies by the year they started, since 2011.
1 of the studies testing glucagon in Hypoglycemia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07818707Joslin Diabetes CenterPost-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH) | 2027-01 |
Among the 32 studies testing glucagon in Hypoglycemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 10 in Hypoglycemia:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of Nasal Glucagon.
Drug: Nasal Glucagon
Single intramuscular (IM) dose of Glucagon.
Drug: Intramuscular Glucagon
Administered nasally
Also known as: LY900018
Administered IM
Also known as: GlucaGen®
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.
Time frame: Pre-dose up to 30 minutes post each glucagon administration
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
Time frame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
| Milestone | NG 1st/IM Glucagon 2nd | IM Glucagon 1st/NG 2nd |
|---|---|---|
| Started | 35 | 35 |
| Received at least 1 dose of study drug | 35 | 35 |
| Completed | 35 | 34 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Milestone | NG 1st/IM Glucagon 2nd | IM Glucagon 1st/NG 2nd |
|---|---|---|
| Started | 35 | 34 |
| Completed | 35 | 34 |
| Not completed | 0 | 0 |
Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.
| Participants | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia | 66 | 66 |
| Milligrams per deciliter (mg/dL) | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) | 132 ± 36 | 161 ± 29 |
| Hour (hr) | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | 1.00 (0.42 to 1.50) | 1.50 (0.83 to 1.50) |
| picogram*hour per millilitre (pg*hr/mL) | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon | 2740 ± 68 | 3320 ± 40 |
| picograms per millilitre (pg/mL) | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | 6130 ± 74 | 3750 ± 44 |
| Hour (hr) | Nasal Glucagon (NG) | IM Glucagon |
|---|---|---|
| PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | 0.25 (0.17 to 0.50) | 0.25 (0.08 to 0.50) |
Collected over First dose of study drug (Day 1) until post-study completion (Day 30).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasal Glucagon (NG) | 0/70 (0%) | 0/70 (0%) | 34/70 (48.6%) |
| Intramuscular (IM) Glucagon | 0/69 (0%) | 0/69 (0%) | 35/69 (50.7%) |
| Event | Nasal Glucagon (NG) | Intramuscular (IM) Glucagon |
|---|---|---|
| NauseaGastrointestinal disorders | 22/70 | 29/69 |
| VomitingGastrointestinal disorders | 10/70 | 12/69 |
| HeadacheNervous system disorders | 11/70 | 7/69 |
| NasopharyngitisInfections and infestations | 4/70 | 2/69 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/70 | 0/69 |
| Abdominal pain upperGastrointestinal disorders | 0/70 | 1/69 |
| DiarrhoeaGastrointestinal disorders | 0/70 | 1/69 |
| Otitis mediaInfections and infestations | 0/70 | 1/69 |
| Body temperature increasedInvestigations | 0/70 | 1/69 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 0/70 | 1/69 |
All enrolled participants.
| Age, Continuous(years) | Glucagon |
|---|---|
| Median | 41.7 ± 12.7 |
| Sex: Female, Male(Participants) | Glucagon |
|---|---|
| Female | 27 |
| Male | 43 |
| Ethnicity (NIH/OMB)(Participants) | Glucagon |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 70 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Glucagon |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 70 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Glucagon |
|---|---|
| Germany | 70 |
| Weight(Kilogram (kg)) | Glucagon |
|---|---|
| Mean | 78.79 ± 13.28 |
| Height(Centimeter (cm)) | Glucagon |
|---|---|
| Mean | 175.21 ± 8.43 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m2)) | Glucagon |
|---|---|
| Mean | 25.53 ± 2.97 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Dec 2017, 1 month.
Results were first posted in Sep 2019, 1 year 9 months after primary completion.
Of 21 phase 1 interventional studies under Hypoglycemia, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 105. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glucagon