A Phase 3 interventional study of Glucagon Nasal Powder and Glucagon Hydrochloride Solution in Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 4 sites in Japan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
Among 17 studies testing glucagon in Diabetes Mellitus — 2 open to participants now, 2 under way, none of them phase 3. Glucagon · Diabetes Mellitus.
Among the 17 studies testing glucagon in Diabetes Mellitus, this one is the 2nd largest by enrollment, is one of 2 that started in 2018, is one of 4 in phase 3, and was the 13th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →2 of the 17 studies testing glucagon in Diabetes Mellitus are 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 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2018.
Median enrollment 26 across the 17 interventional studies. Of the 15 that completed or were terminated, 9 (60%) have results posted.
6 of 17 have an industry lead sponsor. The 9 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.
48 studies in Diabetes Mellitus by Eli Lilly and Company: none open now, 4 under way, 1 of them phase 3. Of 43 finished, 35 (81%) have results posted.
Among the 48 studies in Diabetes Mellitus by Eli Lilly and Company, this one is the 39th largest by enrollment of the 47 interventional ones, is the only one that started in 2018, is one of 24 in phase 3, and was the 35th registered.
Eli Lilly and Company’s Diabetes Mellitus studies by the year they started, since 2001.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing glucagon in Diabetes Mellitus, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 48 in Diabetes Mellitus:
The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.
Drug: Glucagon Nasal Powder
A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)
Drug: Glucagon Hydrochloride Solution
Administered intranasally
Also known as: LY900018
Administered IM
Also known as: GlucaGen®
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).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) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
Time frame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
Time frame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
Time frame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
Time frame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
Time frame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
| Milestone | Glucagon Nasal Powder/Glucagon Hydrochloride | Glucagon Hydrochloride Solution/Glucagon Nasal Powder |
|---|---|---|
| Started | 34 | 41 |
| Received at least one dose of study drug | 33 | 39 |
| Completed | 32 | 37 |
| Not completed | 2 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Did not receive treatment | 1 | 2 |
| Milestone | Glucagon Nasal Powder/Glucagon Hydrochloride | Glucagon Hydrochloride Solution/Glucagon Nasal Powder |
|---|---|---|
| Started | 32 | 37 |
| Completed | 32 | 37 |
| Not completed | 0 | 0 |
| Milestone | Glucagon Nasal Powder/Glucagon Hydrochloride | Glucagon Hydrochloride Solution/Glucagon Nasal Powder |
|---|---|---|
| Started | 32 | 37 |
| Completed | 32 | 37 |
| Not completed | 0 | 0 |
Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).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.
| percentage of participants | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia | 100 | 100 |
PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
| milligram/deciliter (mg/dL) | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) | 113 ± 32 | 119 ± 33 |
PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
| hour | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM | 1.00 (0.50 to 4.02) | 1.50 (0.67 to 4.00) |
PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
| Picogram*hour/milliliter (pg*h/mL) | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM | 4830 ± 89 | 3240 ± 32 |
PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
| picogram/milliliter (pg/mL) | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM | 9520 ± 103 | 3290 ± 37 |
PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
| hour (h) | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM | 0.25 (0.17 to 0.67) | 0.17 (0.08 to 0.67) |
Collected over From Baseline to End of Follow-up (Up to 2 Months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glucagon Nasal Powder | 0/71 (0%) | 0/71 (0%) | 15/71 (21.1%) |
| Glucagon Hydrochloride Solution | 0/70 (0%) | 1/70 (1.4%) | 13/70 (18.6%) |
| Event | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| Vertigo positionalEar and labyrinth disorders | 0/71 | 1/70 |
| Event | Glucagon Nasal Powder | Glucagon Hydrochloride Solution |
|---|---|---|
| NauseaGastrointestinal disorders | 5/71 | 11/70 |
| RhinalgiaRespiratory, thoracic and mediastinal disorders | 6/71 | 0/70 |
| VomitingGastrointestinal disorders | 2/71 | 4/70 |
| Blood pressure increasedInvestigations | 4/71 | 0/70 |
| Blood pressure decreasedInvestigations | 1/71 | 2/70 |
| Ear painEar and labyrinth disorders | 2/71 | 0/70 |
| ToothacheGastrointestinal disorders | 1/71 | 1/70 |
| Feeling abnormalGeneral disorders | 0/71 | 1/70 |
| CystitisInfections and infestations | 0/71 | 1/70 |
| HeadacheNervous system disorders | 1/71 | 1/70 |
All randomized participants who received at least one dose of study drug.
| Age, Continuous(years) | Glucagon Nasal Powder/Glucagon Hydrochloride Solution | Glucagon Hydrochloride Solution/Glucagon Nasal Powder | Total |
|---|---|---|---|
| Mean | 41.7 ± 11.6 | 57.5 ± 9.2 | 50.2 ± 13.0 |
| Sex: Female, Male(Participants) | Glucagon Nasal Powder/Glucagon Hydrochloride Solution | Glucagon Hydrochloride Solution/Glucagon Nasal Powder | Total |
|---|---|---|---|
| Female | 13 | 9 | 22 |
| Male | 20 | 30 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Glucagon Nasal Powder/Glucagon Hydrochloride Solution | Glucagon Hydrochloride Solution/Glucagon Nasal Powder | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 33 | 39 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Glucagon Nasal Powder/Glucagon Hydrochloride Solution | Glucagon Hydrochloride Solution/Glucagon Nasal Powder | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 33 | 39 | 72 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Glucagon Nasal Powder/Glucagon Hydrochloride Solution | Glucagon Hydrochloride Solution/Glucagon Nasal Powder | Total |
|---|---|---|---|
| Japan | 33 | 39 | 72 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Feb 2018 to primary completion in Aug 2018, 5 months.
Results were first posted in Oct 2019, 1 year 1 month after primary completion.
Of 167 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 23. This study's 5 months is below that.
Counting every sponsor, half of 230 studies reached it within 19 months; a quarter within 13 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Glucagon