HypoglycemiaPhase 2AMG102NCT01556594
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
A Phase 2 study testing Nasal Glucagon 1 mg, Nasal Glucagon 2 mg and SC Glucagon in people with Hypoglycemia, run by Eli Lilly and Company at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Nasal Glucagon 1 mg, Nasal Glucagon 2 mg and SC Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jul 2012
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of type 1 diabetes between 2 and 30 years
- Receiving daily insulin injections or insulin pump therapy for at least 2 years
- If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study
- Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2
- Female patients must not be pregnant, and must be using effective contraception.
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
Who cannot join
- History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study
- Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening
- Presence or history of pheochromocytoma (i.e. adrenal gland tumor)
- Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease
- Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy
- Known presence of hereditary problems of galactose and /or lactose intolerance
- History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
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.
Read the detailed description
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.
- Conditions
- Hypoglycemia
- Being tested
- Nasal Glucagon 1 mg, Nasal Glucagon 2 mg, SC Glucagon, Nasal Glucagon 3 mg
- Keywords
- Hypoglycemia, Diabetes mellitus
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Glucagon 1 mgDrug
Also called Dry Powder Nasal Glucagon, AMG504-1, LY900018
Nasal Glucagon 2 mgDrug
Also called Dry Powder Nasal Glucagon, AMG504-1, LY900018
SC GlucagonDrug
Also called Glucagon, Glucagon for injection (rDNA origin)
Nasal Glucagon 3 mgDrug
Also called Dry Powder Nasal Glucagon, AMG504-1, LY900018
| Study group | Role | What they receive |
|---|---|---|
| Nasal Glucagon 1 mg | Experimental | Nasal glucagon (NG) administered as single dose of 1 milligram (mg). Receives: Drug: Nasal Glucagon 1 mg |
| Nasal Glucagon 2 mg | Experimental | NG administered as single dose of 2 mg. Receives: Drug: Nasal Glucagon 2 mg |
| SC Glucagon | Active comparator | Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection. Receives: Drug: SC Glucagon |
| Nasal Glucagon 3 mg | Experimental | NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG). Receives: Drug: Nasal Glucagon 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 3 hours post glucagon administration
Secondary outcomes (5)
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Locemia Solutions ULC
- 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
- NCT01556594
- Sponsor's protocol ID
- 16416
- Other IDs
- I8R-MC-IGBA, AMG102
- Acronym
- AMG102
- Status last verified
- Sep 2019
- First submitted
- 15 Mar 2012
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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.
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
- Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
- ClinicalTrials.gov ID
- NCT01556594
- Acronym / sponsor ID
- AMG102 / 16416
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Locemia Solutions ULC
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 13 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nasal Glucagon 1 mg | Experimental | Drug: Nasal Glucagon 1 mgNasal glucagon (NG) administered as single dose of 1 milligram (mg). |
| Nasal Glucagon 2 mg | Experimental | Drug: Nasal Glucagon 2 mgNG administered as single dose of 2 mg. |
| SC Glucagon | Active comparator | Drug: SC GlucagonGlucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection. |
| Nasal Glucagon 3 mg | Experimental | Drug: Nasal Glucagon 3 mgNG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- History of type 1 diabetes between 2 and 30 years
- Receiving daily insulin injections or insulin pump therapy for at least 2 years
- If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study
- Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2
- Female patients must not be pregnant, and must be using effective contraception.
Key exclusion criteria (7 listed)
- History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study
- Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening
- Presence or history of pheochromocytoma (i.e. adrenal gland tumor)
- Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease
- Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy
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 Glucagon 1 mgAlso: Dry Powder Nasal Glucagon, AMG504-1, LY900018 | Drug | Nasal Glucagon 1 mg |
| Nasal Glucagon 2 mgAlso: Dry Powder Nasal Glucagon, AMG504-1, LY900018 | Drug | Nasal Glucagon 2 mg |
| SC GlucagonAlso: Glucagon, Glucagon for injection (rDNA origin) | Drug | SC Glucagon |
| Nasal Glucagon 3 mgAlso: Dry Powder Nasal Glucagon, AMG504-1, LY900018 | Drug | Nasal Glucagon 3 mg |
Primary outcome
Percentage of Responders
Time frame: Pre-dose; 30 minutes following glucagon administration
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.
Number of Participants With at Least One Adverse Event
Time frame: Within 3 hours post glucagon administration
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.
5 secondary outcomes
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
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.
- Individual participant dataSharing planned: 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nasal Glucagon 1 mg, Nasal Glucagon 2 mg and SC Glucagon in people with Hypoglycemia, run by Eli Lilly and Company at 1 site in Canada.
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 6 inclusion and 7 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 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Aug 2014). 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 Responders (time frame: Pre-dose; 30 minutes following glucagon administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.