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| Name | Class |
|---|---|
| Xeris Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).
There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2) Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension Phase.
Run-in Phase:
Prior to commencing the crossover trial, study enrollment will begin with a 2 week run-in phase to assess hypoglycemia eligibility and compliance.
Crossover Trial Phase:
The Crossover Trial Phase will consist of two (3-week) periods.
The Crossover Trial Phase will include up to 24 participants who complete these study periods. Participants who do not complete both periods or who do not have at least one event during both periods may be replaced.
During the Crossover Trial Phase participants will be randomized into two groups: (1) Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2 and (2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in period 2. Each group with follow the applicable treatment arm according to their randomized group.
Extension Phase:
The Post-Crossover Trial phase will commence upon completion of the second 3-week period of the Crossover Trial Phase. Participants will have a 3 week phase during which time they will decide whether to use mini-dose glucagon or glucose tablets to treat each non-severe hypoglycemic event or to prevent hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-Pen Mini™ (glucagon injection) | Experimental | Participants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement. |
|
| Glucose Tabs | Active Comparator | Participants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-Pen Mini™ (glucagon injection) | Drug | 1st BG check, 1st treatment
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
(150 µg of glucagon per syringe) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level | Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | 60 Minutes |
| CGM Maximum Glucose, Event Level |
Not provided
Inclusion Criteria:
Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
Age: 18.0 to < 65.0 years
Duration of T1D: ≥2.0 years
Body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs
HbA1c <8.5% (point of care or local lab, within past month)
Using continuous subcutaneous insulin infusion (CSII) therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
Continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am - 10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded CGM data
Females must meet one of the following criteria:
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Willing to adhere to the protocol requirements for the duration of the study
Participant has a smart phone available and is able to use it daily
Must be enrolled in the T1D Exchange clinic registry or willing to join the clinic registry
Exclusion Criteria:
More than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
Known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
Males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
Use of non-insulin anti-diabetic medications
Use of daily systemic beta-blocker
Use of beta-adrenergic agonists, theophylline (or other methylxanthines)
Use of 1st generation anticholinergic drugs (such as Brompheniramine, Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine)
Use of systemic corticosteroids
History of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs
History of epilepsy or seizure disorder
Uncontrolled hypertension, >160 mmHg systolic or >100 mmHg diastolic
Currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
Currently following a very low calorie or other weight-loss diet
Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study
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| Name | Affiliation | Role |
|---|---|---|
| Morey W Haymond, MD | Baylor College of Medicine | Study Chair |
| Stephanie N DuBose, MPH | Jaeb Center for Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado/Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States | ||
| Yale University of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19033403 | Background | Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes. 2008 Dec;57(12):3169-76. doi: 10.2337/db08-1084. No abstract available. | |
| 20723825 | Background | Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin North Am. 2010 Sep;39(3):641-54. doi: 10.1016/j.ecl.2010.05.003. |
| Label | URL |
|---|---|
| Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes | View source |
Not provided
26 consented for Run-in; 1 ineligible after consent; 2 ineligible after Run-in phase; 3 withdrew
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| ID | Title | Description |
|---|---|---|
| FG000 | G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs | For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
|
| FG001 | Glucose Tabs, Then G-Pen Mini | For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment:
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Crossover Trial Phase |
|
| ||||||||||||||||||
| Extension Phase |
|
Characteristics of the 16 participants with analyzable hypoglycemic events (1 of 20 participants randomized was dropped due to pregnancy and 3 participants did not have any analyzable hypoglycemic events.)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs | For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
|
| 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 | Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment | Limited to events with starting BG of 50-69 mg/dL | Posted | Count of Units | Hypoglycemic Events | 30 minutes | Hypoglycemic Events | Hypoglycemic Events |
|
Adverse events were collected through study completion, an average of 12 weeks.
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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 Mini™ (Glucagon Injection) | Participants treat non-severe hypoglycemic events with glucagon. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unintended Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment | Not related to study drug or procedures. Recovered with Sequelae |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie DuBose | Jaeb Center for Health Research | 813-975-8690 | t1dstats2@jaeb.org |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005934 | Glucagon |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
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Not provided
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Not provided
|
|
| Glucose Tablets | Other | 1st BG check, 1st treatment
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
(5 grams of fast-acting carbohydrates (D-Glucose) per tablet) |
|
|
Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event |
| 60 Minutes |
| CGM Mean Glucose, Event Level | Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | 60 Minutes |
| CGM Time in Range, Event Level | Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | 60 Minutes |
| CGM Time Below 70 mg/dL, Event Level | Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | 60 Minutes |
| CGM Minimum Glucose, Event Level | Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | 120 Minutes |
| CGM Maximum Glucose, Event Level | Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | 120 Minutes |
| CGM Mean Glucose, Event Level | Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | 120 Minutes |
| CGM Time in Range, Event Level | Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | 120 Minutes |
| CGM Time Below 70 mg/dL | Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | 120 Minutes |
| CGM Mean Glucose | Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period | 3 weeks |
| CGM Time in Range | Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period | 3 weeks |
| CGM Time Below 70 | Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period | 3 weeks |
| CGM Coefficient of Variation | Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period | 3 weeks |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 16492699 | Background | Raju B, Arbelaez AM, Breckenridge SM, Cryer PE. Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. J Clin Endocrinol Metab. 2006 Jun;91(6):2087-92. doi: 10.1210/jc.2005-2798. Epub 2006 Feb 21. |
| 19429875 | Background | Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8. |
| 11315823 | Background | Haymond MW, Schreiner B. Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes. Diabetes Care. 2001 Apr;24(4):643-5. doi: 10.2337/diacare.24.4.643. |
| 16509909 | Background | Hartley M, Thomsett MJ, Cotterill AM. Mini-dose glucagon rescue for mild hypoglycaemia in children with type 1 diabetes: the Brisbane experience. J Paediatr Child Health. 2006 Mar;42(3):108-11. doi: 10.1111/j.1440-1754.2006.00807.x. |
| 15212060 | Background | Hasan KS, Kabbani M. Mini-dose glucagon is effective at diabetes camp. J Pediatr. 2004 Jun;144(6):834. No abstract available. |
| 28591776 | Derived | Haymond MW, DuBose SN, Rickels MR, Wolpert H, Shah VN, Sherr JL, Weinstock RS, Agarwal S, Verdejo AS, Cummins MJ, Newswanger B, Beck RW; T1D Exchange Mini-dose Glucagon Study Group. Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2994-3001. doi: 10.1210/jc.2017-00591. |
| NOT COMPLETED |
|
| BG001 | Glucose Tabs, Then G-Pen Mini | For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment:
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | % |
|
| Duration of Type 1 Diabetes | Mean | Standard Deviation | years |
|
| OG001 | Glucose Tabs | For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment:
15 min later, 2nd BG check, 2nd treatment
30 minutes later, 3rd BG check, 3rd treatment
|
|
|
|
| Secondary | Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level | Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 60 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Maximum Glucose, Event Level | Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 60 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Mean Glucose, Event Level | Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 60 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Time in Range, Event Level | Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 60 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Time Below 70 mg/dL, Event Level | Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 60 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Minimum Glucose, Event Level | Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 120 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Maximum Glucose, Event Level | Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 120 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Mean Glucose, Event Level | Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 120 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Time in Range, Event Level | Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 120 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Time Below 70 mg/dL | Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event | A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 120 Minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Secondary | CGM Mean Glucose | Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period | Limited to participants who had at least 72 hours of CGM data during each period | Posted | Median | Inter-Quartile Range | mg/dL | 3 weeks |
|
|
|
|
| Secondary | CGM Time in Range | Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period | Limited to participants who had at least 72 hours of CGM data during each period | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
|
|
|
| Secondary | CGM Time Below 70 | Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period | Limited to participants who had at least 72 hours of CGM data during each period | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
|
|
|
| Secondary | CGM Coefficient of Variation | Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period | Limited to participants who had at least 72 hours of CGM data during each period | Posted | Median | Inter-Quartile Range | percentage coefficient of variation | 3 weeks |
|
|
|
|
| Post-Hoc | Clinical Grading - Limited to Events in Primary Analysis | 2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm. | Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period. | Posted | Count of Units | Hypoglycemic Events | 60 minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Post-Hoc | Clinical Grading - Initial and 15-min Treatment Correct | 2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm. | Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct. 4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period. | Posted | Count of Units | Hypoglycemic Events | 60 minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| Post-Hoc | Clinical Grading - Initial Treatment Correct | 2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm. | This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements. 8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period. | Posted | Count of Units | Hypoglycemic Events | 60 minutes | Hypoglycemic Events | Hypoglycemic Events |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Glucose Tabs | Participants treat non-severe hypoglycemic events with glucose tabs. | 0 | 20 | 0 | 20 | 1 | 20 |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Not related to study drug or procedures. Complete Recovery. |
|
| Streptococcal Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Not related to study drug or procedures. Occurred during Extension Phase when participant taking both G-Pen Mini and Glucose Tabs. Complete Recovery. |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |