HypoglycemiaPhase 1NCT03339453
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
A Phase 1 study testing Nasal Glucagon and Intramuscular Glucagon in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 2 sites in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus, Type 1
- What is being tested?
- Nasal Glucagon and Intramuscular Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesGermany
- Study dates
- 10 Nov 2017to 13 Jan 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis
Who cannot join
- Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
- Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
- Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
- Have a history of epilepsy or seizure disorder
- Are women who are pregnant or lactating
- Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
- Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
- Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Mainz, 55116
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Neuss
About this study
Official title: Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
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).
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- Nasal Glucagon, Intramuscular Glucagon
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal GlucagonDrug
Also called LY900018
Administered nasally
Intramuscular GlucagonDrug
Also called GlucaGen®
Administered IM
| Study group | Role | What they receive |
|---|---|---|
| Nasal Glucagon | Experimental | Single dose of Nasal Glucagon. Receives: Drug: Nasal Glucagon |
| Intramuscular Glucagon | Active comparator | Single intramuscular (IM) dose of Glucagon. Receives: Drug: Intramuscular Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-dose up to 30 minutes post each glucagon administration
Secondary outcomes (5)
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start10 Nov 2017
- Primary completion17 Dec 2017
- Study completion13 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339453
- Sponsor's protocol ID
- 16547
- Other IDs
- I8R-MC-IGBI, 2017-000249-33, 2017
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2017
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19.
PubMed 38444629Suico JG, Hovelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Morschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7. Epub 2020 Jun 8.
PubMed 32514794
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
- ClinicalTrials.gov ID
- NCT03339453
- Acronym / sponsor ID
- 16547
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 13 Jan 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Glucagon | Experimental | Drug: Nasal GlucagonSingle dose of Nasal Glucagon. |
| Intramuscular Glucagon | Active comparator | Drug: Intramuscular GlucagonSingle intramuscular (IM) dose of Glucagon. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis
Key exclusion criteria (8 listed)
- Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
- Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
- Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
- Have a history of epilepsy or seizure disorder
- Are women who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal GlucagonAlso: LY900018Administered nasally | Drug | Nasal Glucagon |
| Intramuscular GlucagonAlso: GlucaGen®Administered IM | Drug | Intramuscular Glucagon |
Primary outcome
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Time frame: Pre-dose up to 30 minutes post each glucagon administration
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.
5 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38444629Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19.
- Derived from this study: PubMed 32514794Suico JG, Hovelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Morschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7. Epub 2020 Jun 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nasal Glucagon and Intramuscular Glucagon in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (time frame: Pre-dose up to 30 minutes post each glucagon administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339453, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.