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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DK096706-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Emissary International LLC | INDUSTRY |
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The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-Pump™ (glucagon infusion) | Experimental | G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
|
| Novo Nordisk GlucaGen® | Active Comparator | Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novo Nordisk GlucaGen® | Drug | single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) | The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon. | 0 to 150 minutes post-dosing |
| Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early) | The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon. | 0 to 150 minutes post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon Cmax | Maximum plasma concentration of glucagon | From 0 to 150 minutes post-dosing |
| Glucose Cmax | Maximum plasma concentration of glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Castle, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
A total of 30 subjects were screened for study inclusion. The 19 subjects who met all eligibility criteria were randomized and assigned to treatment.
A total of 19 adults ages 18-65 years with type 1 diabetes were recruited over a period of 4 months to receive treatment at a public university hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG001 | Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| FG002 | Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG003 | Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| FG004 | Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG005 | Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| FG006 | Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG007 | Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| FG008 | Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG009 | Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| FG010 | Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit. |
| FG011 | Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump | Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Xeris G-Pump Glucagon First, Followed by GlucaGen | Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit. |
| BG001 | GlucaGen First, Followed by Xeris G-Pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) | The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon. | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis. | Posted | Mean | Standard Deviation | minutes | 0 to 150 minutes post-dosing |
|
Adverse event information was collected from the time a subject provided written informed consent at the screening visit through the follow-up visit occurring 3-14 days after the final dose of study drug, a total time of 6-10 weeks per subject.
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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-Pump™ (Glucagon Infusion) | G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Cummins, VP for Drug Development | Xeris Pharmaceuticals, Inc. | 512-498-2675 | mcummins@xerispharma.com |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| G-Pump™ (glucagon infusion) | Drug | single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg |
|
| From 0 to 150 minutes post-dosing |
| Glucagon Tmax | Time to maximum plasma concentration of glucagon | From 0 to 150 minutes post-dosing |
| Glucose Tmax | Time to maximum plasma concentration of glucose | From 0 to 150 minutes post-dosing |
| Glucagon AUC | Area under the plasma concentration time curve for glucagon | From 0 to 150 minutes post-dosing |
| Glucose AUC | Area under the plasma concentration time curve for glucose | From 0 to 150 minutes post-dosing |
| Infusion Site Discomfort Score at 10 Minutes | Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score. | At 10 minutes post-dosing |
| Infusion Site Discomfort Score at 30 Minutes | Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score. | At 30 minutes post-dosing |
Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 1.2 μg/kg G-Pump |
1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump |
| OG002 | 2.0 μg/kg G-Pump | 2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump |
| OG003 | 0.3μg/kg GlucaGen | 0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump |
| OG004 | 1.2 μg/kg GlucaGen | 1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump |
| OG005 | 2.0 μg/kg GlucaGen | 2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump |
|
|
|
| Primary | Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early) | The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon. | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | minutes | 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucagon Cmax | Maximum plasma concentration of glucagon | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | pg/dl | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucose Cmax | Maximum plasma concentration of glucose | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | mg/dl | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucagon Tmax | Time to maximum plasma concentration of glucagon | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | minutes | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucose Tmax | Time to maximum plasma concentration of glucose | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis. | Posted | Mean | Standard Deviation | minutes | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucagon AUC | Area under the plasma concentration time curve for glucagon | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | (pg/dl)*minutes | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Glucose AUC | Area under the plasma concentration time curve for glucose | All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. | Posted | Mean | Standard Deviation | (mg/dl)*minutes | From 0 to 150 minutes post-dosing |
|
|
|
|
| Secondary | Infusion Site Discomfort Score at 10 Minutes | Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score. | All treated subjects | Posted | Mean | Standard Deviation | mm | At 10 minutes post-dosing |
|
|
|
|
| Secondary | Infusion Site Discomfort Score at 30 Minutes | Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score. | All treated subjects | Posted | Mean | Standard Deviation | mm | At 30 minutes post-dosing |
|
|
|
|
| 0 |
| 19 |
| 16 |
| 19 |
| EG001 | Novo Nordisk GlucaGen® | Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump | 0 | 18 | 12 | 18 |
| Infusion site swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Drug withdrawal headache | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Catheter site rash | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| 0.09 |
| Point estimate ratio |
| 1.29 |
| Standard Error of the Mean |
| 0.18 |
| 2-Sided |
| 90 |
| 1.01 |
| 1.65 |
| Superiority or Other |
| Mixed Models Analysis | 0.02 | Point estimate ratio | 1.36 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | 1.11 | 1.67 | Superiority or Other |
| 0.24 |
| Point estimate ratio |
| 1.29 |
| Standard Error of the Mean |
| 0.26 |
| 2-Sided |
| 90 |
| 0.90 |
| 1.84 |
| Superiority or Other |
| Mixed Models Analysis | 0.31 | Point estimate ratio | 0.83 | Standard Error of the Mean | 0.15 | 2-Sided | 90 | 0.60 | 1.14 | Superiority or Other |
| 0.29 |
| Point estimate ratio |
| 1.12 |
| Standard Error of the Mean |
| 0.12 |
| 2-Sided |
| 90 |
| 0.93 |
| 1.35 |
| Superiority or Other |
| Mixed Models Analysis | 0.24 | Point estimate ratio | 1.11 | Standard Error of the Mean | 0.09 | 2-Sided | 90 | 0.96 | 1.28 | Superiority or Other |
| 0.19 |
| Point estimate ratio |
| 1.26 |
| Standard Error of the Mean |
| 0.21 |
| 2-Sided |
| 90 |
| 0.94 |
| 1.68 |
| Superiority or Other |
| Mixed Models Analysis | 0.052 | Point estmate ratio | 1.45 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | 1.07 | 1.98 | Superiority or Other |
| 0.48 |
| Point estimate ratio |
| 1.31 |
| Standard Error of the Mean |
| 0.49 |
| 2-Sided |
| 90 |
| 0.68 |
| 2.54 |
| Superiority or Other |
| Mixed Models Analysis | 0.28 | Point estimate ratio | 0.80 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | 0.57 | 1.13 | Superiority or Other |
| 0.22 |
| Point estimate ratio |
| 1.19 |
| Standard Error of the Mean |
| 0.16 |
| 2-Sided |
| 90 |
| 0.94 |
| 1.5 |
| Superiority or Other |
| Mixed Models Analysis | 0.26 | Point estimate ratio | 0.84 | Standard Error of the Mean | 0.12 | 2-Sided | 90 | 0.66 | 1.09 | Superiority or Other |
| Point estimate ratio |
| 1.15 |
| Standard Error of the Mean |
| 0.12 |
| 2-Sided |
| 90 |
| 0.95 |
| 1.38 |
| Superiority or Other |
| Mixed Models Analysis | 0.19 | Point estimate ratio | 1.13 | Standard Error of the Mean | 0.10 | 2-Sided | 90 | 0.97 | 1.31 | Superiority or Other |
| 0.0005 |
| Mean Difference (Final Values) |
| -19.4 |
| Standard Error of the Mean |
| 5.4 |
| 2-Sided |
| 95 |
| -30.1 |
| -8.7 |
| Superiority or Other |
| Mixed Models Analysis | <0.0001 | Mean Difference (Net) | -23.3 | Standard Error of the Mean | 5.4 | 2-Sided | 95 | -34.0 | -12.6 | Superiority or Other |
| 0.58 |
| Mean Difference (Net) |
| -0.9 |
| Standard Error of the Mean |
| 1.6 |
| 2-Sided |
| 95 |
| -4.0 |
| 2.3 |
| Superiority or Other |
| Mixed Models Analysis | 0.03 | Mean Difference (Net) | -3.6 | Standard Error of the Mean | 1.6 | 2-Sided | 95 | -6.7 | -0.4 | Superiority or Other |