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This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use [RTU] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.
There were 2 phases of this study: CRC and Outpatient. The initial posting of this study reflected the 3 treatment arms included in the Outpatient Phase of the study, without including the CRC and Outpatient Phases separately.
CRC Phase:
The CRC Phase was comprised of 2 visits that included daytime exercise sessions at the CRC or a comparable setting. Subjects were randomized to receive their first treatment at Visit 3 and crossed over (2 to 28 day washout) to their second treatment at Visit 4. The treatments were a single treatment with 30 microliters of either Glucagon RTU (0.15 mg) or placebo with a 50% insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, at the start of exercise, and then 15, 30, 45, 60, and 75 minutes from the start of exercise.
Outpatient Phase:
After completion of the CRC Phase, subjects entered the 12-week Outpatient Phase. Subjects were to maintain a weekly exercise average of 2 to 3 sessions of at least 30 minutes duration. Subjects were assigned randomly in 1:1:1 ratio to administer 30 microliters of one of the following prior to the exercise sessions: Glucagon RTU (0.15 mg) with a 50% insulin pump reduction, placebo with a 50% pump reduction or Glucagon RTU (0.15 mg) without an insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, just before exercise, after 30 minutes of exercise, at the end of exercise (if longer than 30 minutes), and 30 minutes post-exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRC Phase: Glucagon RTU With Insulin Pump Reduction | Experimental | CRC Phase: 2-arm randomized double-blind crossover, Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump |
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| CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Placebo Comparator | CRC Phase: 2-arm randomized double-blind crossover, Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump |
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| Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Experimental | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm) |
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| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Placebo Comparator | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
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| Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon RTU Injection With Insulin Pump Reduction | Drug | 0.15 mg injection with 50% pump reduction |
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| Measure | Description | Time Frame |
|---|---|---|
| Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. | Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if >1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. | Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session. |
| Outpatient Phase: Mean Number of Hypoglycemic Events | Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1). | Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
| Measure | Description | Time Frame |
|---|---|---|
| CRC Phase: Interstitial Glucose Below Target Range | Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise. | Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled Junaidi, MD | Xeris Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Clinical Research Inc | Toronto | Ontario | M4G 3E8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36689626 | Result | Aronson R, Riddell MC, Conoscenti V, Junaidi MK. Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. Diabetes Care. 2023 Apr 1;46(4):765-772. doi: 10.2337/dc22-1145. |
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The study enrolled 48 subjects to participate in the study with a CRC phase followed by an Outpatient phase. The 45 subjects that completed the CRC phase were re-randomized prior to entering the Outpatient phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| CRC Phase: First Treatment |
|
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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 | Jun 20, 2019 | May 17, 2021 |
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CRC Phase: randomized, placebo-controlled, double-blind, two-treatment, two-period, crossover comparison in a clinical research center (CRC) setting. The subjects were re-randomized into the Outpatient Phase: randomized, placebo-controlled, partially double-blind, 3-arm parallel comparison in an outpatient setting.
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CRC Phase was a fully masked double-blind crossover with each subject receiving each treatment 1 time. In the Outpatient Phase, the two arms with 50% insulin pump reduction were double-blind (fully masked) and the arm with Glucagon RTU and no insulin pump reduction was open-label.
| Experimental |
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
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| Vehicle for Glucagon RTU Injection With Insulin Pump Reduction | Other | vehicle injection with 50% pump reduction |
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| Glugaon RTU Injection Without Insulin Pump Reduction | Drug | 0.15 mg injection without pump reduction |
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| Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1). | Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily. |
| Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of the exercise session corresponding to each of the treatments during the corresponding in-clinic visit during the CRC Phase. |
| Outpatient Phase: Interstitial Glucose Levels Below Target Range | Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L) | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of each qualified exercise session corresponding to each of the treatments during the Outpatient Phase. |
| Outpatient Phase: Insulin Use Change From Baseline | Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 | Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 |
| Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline | Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise. The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7. | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
| Outpatient Phase: HFS-II Overall Score Change From Baseline | Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II) A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following: Behavior (15 items): things that people with diabetes often do to avoid low blood sugar. Worry (18 items): things that people with diabetes often worry about because of low blood sugar. Lower scores are considered better outcomes, higher scores are considered worse outcomes. The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4. | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
| Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline | Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS) The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise. The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4. | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
| Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
| CRC Phase: Mean Number of Hypoglycemic Events Exercise. | CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level. A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
| CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the number of qualified exercise sessions that occurred. |
| FG001 | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm) |
| FG002 | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction | CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm) |
| FG003 | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm) |
| FG004 | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm) |
| FG005 | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction | CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm) |
| Received 1st CRC Dose |
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| COMPLETED |
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| NOT COMPLETED |
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| CRC Phase: Second Treatment |
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| Outpatient Phase Treatment |
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Baseline information is presented for the Safety population for the CRC Phase (Period 1) of the study, this includes all randomized subjects who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucagon RTU Crossover to Placebo | CRC Stage: Glucagon RTU to Placebo Crossover Group (Glucagon RTU Injection 30 microliters of 0.15 mg injection crossover to vehicle injection of 30 microliters) with 50% reduction in the insulin pump |
| BG001 | Placebo Crossover to Glucagon RTU | CRC Stage: Placebo to Glucagon RTU Crossover Group (vehicle injection of 30 microliters crossover to Glucagon RTU Injection 30 microliters of 0.15 mg injection) with 50% reduction in the insulin pump |
| 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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| Age, Continuous | Mean | Standard Deviation | years |
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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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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. | Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if >1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. | All randomized subjects in the Outpatient Phase with data. | Posted | Number | events/session | Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session. |
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| Primary | Outpatient Phase: Mean Number of Hypoglycemic Events | Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1). | All randomized subjects in the Outpatient Phase with data. | Posted | Number | mean number of events/participant | Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
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| Primary | Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1). | All randomized subjects in the Outpatient Phase with data. | Posted | Number | mean number of sessions/participant | Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily. |
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| Secondary | CRC Phase: Interstitial Glucose Below Target Range | Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L) | All randomized subjects in the CRC phase. | Posted | Count of Participants | Participants | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of the exercise session corresponding to each of the treatments during the corresponding in-clinic visit during the CRC Phase. |
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| Secondary | Outpatient Phase: Interstitial Glucose Levels Below Target Range | Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L) | All randomized subjects in the Outpatient Phase with data. | Posted | Count of Participants | Participants | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of each qualified exercise session corresponding to each of the treatments during the Outpatient Phase. |
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| Secondary | Outpatient Phase: Insulin Use Change From Baseline | Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 | All randomized subjects in the Outpatient Phase with change from Outpatient Phase Baseline data available at Study Weeks 4, 8, and 12 | Posted | Mean | Standard Deviation | units of insulin | Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12 |
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| Secondary | Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline | Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise. The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7. | All randomized subjects in the Outpatient Phase with data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
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| Secondary | Outpatient Phase: HFS-II Overall Score Change From Baseline | Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II) A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following: Behavior (15 items): things that people with diabetes often do to avoid low blood sugar. Worry (18 items): things that people with diabetes often worry about because of low blood sugar. Lower scores are considered better outcomes, higher scores are considered worse outcomes. The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4. | All randomized subjects in the Outpatient Phase with data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
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| Secondary | Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline | Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS) The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise. The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4. | All randomized subjects in the Outpatient Phase with data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation) |
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| Other Pre-specified | CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise. | Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. | All randomized subjects in the CRC Phase. | Posted | Number | events/session | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
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| Other Pre-specified | CRC Phase: Mean Number of Hypoglycemic Events Exercise. | CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level. A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session. | All randomized subjects in the CRC Phase. | Posted | Number | number of events/participant | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session. |
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| Other Pre-specified | CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. | All randomized subjects in the CRC Phase. | Posted | Number | mean number of sessions/participant | Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the number of qualified exercise sessions that occurred. |
|
From signing of Informed Consent Form through the followup visit (week 12)
Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: 2-arm randomized double-blind crossover, Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump | 0 | 46 | 0 | 46 | 27 | 46 |
| EG001 | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | CRC Phase: 2-arm randomized double-blind crossover, Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in insulin pump | 0 | 47 | 0 | 47 | 30 | 47 |
| EG002 | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm) | 0 | 16 | 0 | 16 | 14 | 16 |
| EG003 | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in insulin pump (double-blind arm) | 0 | 14 | 0 | 14 | 12 | 14 |
| EG004 | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) | 0 | 14 | 0 | 14 | 12 | 14 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Injection site paresthesia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Application site rash | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal distension | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Toothache | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Decreased appetiate | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Harper, VP Clinical Devlopment | Xeris Pharmaceuticals | 1-877-XERIS-37 | clinicaltrials@xerispharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2019 | May 17, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
Not provided
Not provided
| Adverse Event |
|
| Withdrawal by Subject |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used. | Tukey Test/Kruskal-Wallis Test | Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed). | <0.0001 | Other |
| If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used. | Tukey Test/Kruskal-Wallis Test | Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed). | 0.0032 | Other |
| If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used. | Tukey Test/Kruskal-Wallis Test | Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed). | 0.2072 | Other |
| OG001 |
| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction |
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
| OG002 | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
| OG003 | Outpatient Phase: Overall | All 3 treatment groups in the Outpatient Phase |
|
|
| OG002 | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
| OG003 | Outpatient Phase: Overall | All 3 treatment groups in the Outpatient Phase |
|
|
| OG002 | CRC Phase: Overall | CRC Phase: Glucagon RTU and/or Vehicle 30 microliters with 50% reduction in insulin pump |
|
|
|
| Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), glucagon RTU injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
| OG003 | Outpatient Phase: Overall | Outpatient Phase: All subjects across the 3 treatment arms in the Outpatient Phase. |
|
|
|
|
|
| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction |
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
| OG002 | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
|
|
| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction |
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
| OG002 | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
|
|
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm) |
| OG002 | Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm) |
|
|
| OG001 |
| CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction |
CRC Phase: Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (crossover groups combined) |
| OG002 | CRC Phase: Overall | CRC Phase: Glucagon RTU and/or Vehicle Injection 30 microliters with a 50% reduction in the insulin pump (crossover groups combined) |
|
|
CRC Phase: Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (crossover groups combined)
| OG002 | CRC Phase: Overall | CRC Phase: Glucagon RTU and/or Vehicle Injection 30 microliters with a 50% reduction in the insulin pump (crossover groups combined) |
|
|
| OG002 | CRC Phase: Overall | CRC Phase: Glucagon RTU and/or Vehicle Injection 30 microliters with a 50% reduction in the insulin pump (crossover groups combined) |
|
|