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This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xeris glucagon | Experimental | Xeris glucagon 50 micrograms, subcutaneous injection |
|
| Lilly glucagon | Active Comparator | Lilly glucagon 30 micrograms, subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeris glucagon | Drug | The subject is given an injection of xeris glucagon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | tmax for Xeris vs. Lilly (non-inferiority) | every 2 minutes for 1 hour post-dose of each glucagon |
| Measure | Description | Time Frame |
|---|---|---|
| AOCGIR | Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority) | every 2 minutes for 1 hour post-dose of each glucagon |
| GIRmin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
20 subjects were enrolled in this study. One was ineligible after enrollment. 4 were enrolled and eligible, but were not able to schedule their study visit. 2 participated in "test run" experiments as we adjusted glucagon doses to account for concentration differences. 13 subjects completed experiments using the same protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xeris Glucagon First, Then Lilly Glucagon | Xeris glucagon 50 micrograms, subcutaneous injection then Lilly glucagon 30 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon |
| FG001 | Lilly Glucagon First, Then Xeris Glucagon | Lilly glucagon 30 micrograms, subcutaneous injection then Xeris glucagon 50 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xeris Glucagon First, Then Lilly Glucagon | Xeris glucagon 50 micrograms, subcutaneous injection, then Lilly glucagon 30 micrograms, subcutaneous injection Xeris glucagon: The subject is given an injection of xeris glucagon Lilly glucagon: The subject is given an injection of lilly glucagon |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tmax | tmax for Xeris vs. Lilly (non-inferiority) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | minutes | every 2 minutes for 1 hour post-dose of each glucagon |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xeris Glucagon | Xeris glucagon 50 micrograms, subcutaneous injection Xeris glucagon: The subject is given an injection of xeris glucagon |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Balliro, BS, RN, CDE | Massachusetts General Hospital | 617-726-1242 | cballiro@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2014 | Aug 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Lilly glucagon |
| Drug |
The subject is given an injection of lilly glucagon |
|
Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)
| every 2 minutes for 1 hour post-dose of each glucagon |
| t½Max | Glucagon t½max for Xeris vs. Lilly (non-inferiority) | every 2 minutes for 1 hour post-dose of each glucagon |
| Injection Pain | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon | immediately after injection |
| Injection Site Erythema | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection | within 1 hour of injection |
| Maximal Nausea | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10 | within 1 hour of injection |
| Dermal Response (Draize Scale for Erythema and Eschar Formation) | Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest) | within 1 hour of injection |
| Dermal Response (Draize Scale Grade for Edema Formation) | Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest) | within 1 hour of injection |
| Lilly Glucagon First, Then Xeris Glucagon |
Lilly glucagon 30 micrograms, subcutaneous injection, then Xeris glucagon 50 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon Xeris glucagon: The subject is given an injection of xeris glucagon |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | percent |
|
Lilly glucagon 30 micrograms, subcutaneous injection
Lilly glucagon: The subject is given an injection of lilly glucagon
|
|
| Secondary | AOCGIR | Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | mg*min/kg | every 2 minutes for 1 hour post-dose of each glucagon |
|
|
|
| Secondary | GIRmin | Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | dextrose mg/kg/min | every 2 minutes for 1 hour post-dose of each glucagon |
|
|
|
| Secondary | t½Max | Glucagon t½max for Xeris vs. Lilly (non-inferiority) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | minutes | every 2 minutes for 1 hour post-dose of each glucagon |
|
|
|
| Secondary | Injection Pain | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | cm | immediately after injection |
|
|
|
| Secondary | Injection Site Erythema | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | cm | within 1 hour of injection |
|
|
|
| Secondary | Maximal Nausea | Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10 | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Number | cm | within 1 hour of injection |
|
|
|
| Secondary | Dermal Response (Draize Scale for Erythema and Eschar Formation) | Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | score on draize scale | within 1 hour of injection |
|
|
|
| Secondary | Dermal Response (Draize Scale Grade for Edema Formation) | Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest) | 13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug. | Posted | Mean | Standard Deviation | score on draize scale | within 1 hour of injection |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Lilly Glucagon | Lilly glucagon 30 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon | 0 | 13 | 0 | 13 | 0 | 13 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |