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| Name | Class |
|---|---|
| Empiristat, Inc. | INDUSTRY |
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This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-Pen followed by Novo Glucagon | Experimental | 1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit |
|
| Novo Glucagon followed by G-Pen | Active Comparator | 1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-Pen | Drug | 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoglycemia Rescue | Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes after administration of glucagon | At 30 minutes following administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Response 1 | Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose | At 30 minutes following a decision to administer study drug |
| Plasma Glucose Response 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Atlanta Diabetes Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35322535 | Derived | Pieber TR, Aronson R, Christiansen MP, Bode B, Junaidi K, Conoscenti V. Efficacy, safety, tolerability, and noninferiority phase 3 study of glucagon as a ready-to-use room temperature liquid stable formulation versus a lyophilised formulation for the biochemical recovery and symptomatic relief of insulin-induced severe hypoglycaemia in adults with type 1 diabetes. Diabetes Obes Metab. 2022 Jul;24(7):1394-1397. doi: 10.1111/dom.14699. Epub 2022 Apr 28. No abstract available. |
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132 subjects were randomized, however 1 subject withdrew prior to dosing, therefore 131 subjects received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | G-Pen, Then Novo Glucagon | Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection |
| FG001 | Novo Glucagon, Then G-Pen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2018 | Mar 10, 2020 |
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| Novo Glucagon | Drug | 1 mg subcutaneous injection of Novo Glucagon (glucagon injection) |
|
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Number of subjects with an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) after administration of glucagon. |
| At 0-30 minutes following a decision to administer study drug |
| Administration Time | Mean time (minutes) to administer study drug from a decision to dose | At 0-10 minutes from a decision to administer study drug |
| Hypoglycemia Resolution | Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose | At 0-90 minutes following administration of study drug |
| Atlanta |
| Georgia |
| 30318 |
| United States |
| PPD-Las Vegas Clinical Research Unit | Las Vegas | Nevada | 89113 | United States |
| Rainier Research Center | Renton | Washington | 98057 | United States |
| Medizinische Universität Graz-Center for Medical Research | Graz | 8010 | Austria |
| LMC Diabetes & Endocrinology | Toronto | Ontario | M4G 3E8 | Canada |
| AltaSciences | Montreal | Quebec | H3P 3P1 | Canada |
Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection
| COMPLETED |
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| NOT COMPLETED |
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All Randomized Population
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| ID | Title | Description |
|---|---|---|
| BG000 | G-Pen, Then Novo Glucagon | Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection. |
| BG001 | Novo Glucagon, Then G-Pen | Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Severe Hypoglycemia Rescue | Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes after administration of glucagon | Intent-to-Treat Population | Posted | Count of Participants | Participants | At 30 minutes following administration of study drug |
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| Secondary | Plasma Glucose Response 1 | Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose | Intent-to-Treat Population | Posted | Count of Participants | Participants | At 30 minutes following a decision to administer study drug |
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| Secondary | Plasma Glucose Response 2 | Number of subjects with an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) after administration of glucagon. | Intent-to-Treat Population | Posted | Count of Participants | Participants | At 0-30 minutes following a decision to administer study drug |
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| Secondary | Administration Time | Mean time (minutes) to administer study drug from a decision to dose | Intent-to-Treat Population | Posted | Mean | Standard Deviation | minutes | At 0-10 minutes from a decision to administer study drug |
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| Secondary | Hypoglycemia Resolution | Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose | Intent-to-Treat Population | Posted | Mean | Standard Deviation | minutes | At 0-90 minutes following administration of study drug |
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Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit.
Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event
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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 | G-Pen | G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector | 0 | 127 | 0 | 127 | 67 | 127 |
| EG001 | Novo Glucagon | Novo Glucagon: 1 mg subcutaneous injection of Novo Glucagon (glucagon injection) | 0 | 123 | 0 | 123 | 57 | 123 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
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Neither the Institution nor the principal investigator may submit for publication or presentation, the results of this trial without prior written consent of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Boundy | Xeris Pharmaceuticals, Inc. | 312-517-1466 | cboundy@xerispharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2019 | Mar 10, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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