Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44DK096715-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Emissary International LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-Pen Miniâ„¢ (glucagon injection) 75 ug | Experimental | G-Pen Miniâ„¢ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart |
|
| G-Pen Miniâ„¢ (glucagon injection) 150 ug | Experimental | G-Pen Miniâ„¢ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart |
|
| G-Pen Miniâ„¢ (glucagon injection) 300 ug | Experimental | G-Pen Miniâ„¢ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-Pen Miniâ„¢ (glucagon injection) | Drug | stable, pre-mixed, liquid glucagon for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Number of serious adverse events (SAEs) per treatment | From first dose until follow-up call, up to 7 weeks per subject |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon Cmax (Fasting) | Pharmacokinetic parameter: Maximum concentration of glucagon | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
| Glucagon Cmax (Post-insulin) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy
Any chronic diseases or illness that interferes with glucose metabolism, except for T1DM, or medications other than hypothyroidism on appropriate thyroid hormone replacement.
Blood pressure (BP) readings at Screening where Systemic BP <90 or >140 mm Hg, and Diastolic BP <50 or >90 mm Hg.
Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack.
Study participants who are pregnant at Screening.
Breast feeding must be discontinued if a subject wishes to participate in this study.
Positive test for hepatitis B, hepatitis C, or HIV found at Screening.
Positive urine drug test for illicit drugs at Screening.
History of allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation.
Known presence of hereditary problems of glycogen storage disease, galactose and /or lactose intolerance
Administration of glucagon more than once within the three (3) months prior to Screening
Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary:
History of regular alcohol consumption as defined by alcohol intake in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor.
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 and during participation in the current study
Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed red blood cells, platelets or quantities less than 500 mL are allowed at investigator discretion.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Morey W Haymond, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26861921 | Result | Haymond MW, Redondo MJ, McKay S, Cummins MJ, Newswanger B, Kinzell J, Prestrelski S. Nonaqueous, Mini-Dose Glucagon for Treatment of Mild Hypoglycemia in Adults With Type 1 Diabetes: A Dose-Seeking Study. Diabetes Care. 2016 Mar;39(3):465-8. doi: 10.2337/dc15-2124. Epub 2016 Feb 9. |
Not provided
Not provided
A total of 13 subjects were randomized to treatment. Due to poor venous access an IV could not be started in one subject, so only 12 subjects received treatment.
A total of 13 adults < 50 years of age with type 1 diabetes were recruited over a period of 5 months to receive treatment at a university-affiliated state hospital-based endocrinology clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G-Pen Miniâ„¢ Dose Order: 75, 150 & 300 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3. |
| FG001 | G-Pen Miniâ„¢ Dose Order: 75, 300 & 150 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3. |
| FG002 | G-Pen Miniâ„¢ Dose Order: 150, 75 & 300 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3. |
| FG003 | G-Pen Miniâ„¢ Dose Order: 150, 300 & 75 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3. |
| FG004 | G-Pen Miniâ„¢ Dose Order: 300, 75 & 150 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3. |
| FG005 | G-Pen Miniâ„¢ Dose Order: 300, 150 & 75 Micrograms | G-Pen Miniâ„¢ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized subjects who received at least one dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Group | Includes all 12 treated subjects |
| 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 | Serious Adverse Events | Number of serious adverse events (SAEs) per treatment | All randomized subjects who received at least one dose of study drug | Posted | Number | participants | From first dose until follow-up call, up to 7 weeks per subject |
|
Not provided
Not provided
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 | G-Pen Miniâ„¢ (Glucagon Injection) 75 ug | G-Pen Miniâ„¢ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blurred vision | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Cummins, VP Drug Development | Xeris Pharmaceuticals, Inc. | 512-498-2675 | mjcummins@xerispharma.com |
Not provided
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Pharmacokinetic parameter: Maximum concentration of glucagon
| Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucagon Area Under the Curve (AUC) (Fasting) | Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucagon AUC (Post-insulin) | Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucagon Tmax (Fasting) | Pharmacokinetic parameter: Time to reach maximum concentration of glucagon | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
| Glucagon Tmax (Post-insulin) | Pharmacokinetic parameter: Time to reach maximum concentration of glucagon | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucose Cmax (Fasting) | Pharmacodynamic parameter: Maximum concentration of glucose | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
| Glucose Cmax (Post-insulin) | Pharmacodynamic parameter: Maximum concentration of glucose | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucose AUC (Fasting) | Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucose AUC (Post-insulin) | Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| Glucose Tmax (Fasting) | Pharmacodynamic parameter: Time to reach maximum concentration of glucose | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
| Glucose Tmax (Post-insulin) | Pharmacodynamic parameter: Time to reach maximum concentration of glucose | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
| 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 |
|
| HbA1c | Mean | Standard Deviation | percent |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| OG002 | G-Pen Miniâ„¢ (Glucagon Injection) 300 ug | G-Pen Miniâ„¢ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart |
|
|
| Secondary | Glucagon Cmax (Fasting) | Pharmacokinetic parameter: Maximum concentration of glucagon | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | pg/ml | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
|
|
|
|
| Secondary | Glucagon Cmax (Post-insulin) | Pharmacokinetic parameter: Maximum concentration of glucagon | All randomized subject who received at least one dose of study drug | Posted | Mean | Standard Error | pg/ml | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucagon Area Under the Curve (AUC) (Fasting) | Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | (pg/ml)*hour | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucagon AUC (Post-insulin) | Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | (pg/ml)*hour | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucagon Tmax (Fasting) | Pharmacokinetic parameter: Time to reach maximum concentration of glucagon | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
|
|
|
|
| Secondary | Glucagon Tmax (Post-insulin) | Pharmacokinetic parameter: Time to reach maximum concentration of glucagon | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucose Cmax (Fasting) | Pharmacodynamic parameter: Maximum concentration of glucose | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | mg/dl | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
|
|
|
|
| Secondary | Glucose Cmax (Post-insulin) | Pharmacodynamic parameter: Maximum concentration of glucose | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | mg/dl | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucose AUC (Fasting) | Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | (mg/dl)*minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucose AUC (Post-insulin) | Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | (mg/dl)*minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| Secondary | Glucose Tmax (Fasting) | Pharmacodynamic parameter: Time to reach maximum concentration of glucose | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection |
|
|
|
|
| Secondary | Glucose Tmax (Post-insulin) | Pharmacodynamic parameter: Time to reach maximum concentration of glucose | All randomized subjects who received at least one dose of study drug | Posted | Mean | Standard Error | minutes | Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection |
|
|
|
|
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | G-Pen Miniâ„¢ (Glucagon Injection) 150 ug | G-Pen Miniâ„¢ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart | 0 | 12 | 11 | 12 |
| EG002 | G-Pen Miniâ„¢ (Glucagon Injection) 300 ug | G-Pen Miniâ„¢ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart | 0 | 12 | 11 | 12 |
| nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| paresthesia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| hypoesthesia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| nodule | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| pain | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| bruising | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| edema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | at injection site |
|
| hypoglycemia | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| paresthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | in fingers |
|
| Skin reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | reaction to adhesive used to secure IV line |
|
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| <0.05 |
| Point estimate ratio |
| 0.35 |
| Standard Error of the Mean |
| 0.04 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Point estimate ratio | 0.57 | Standard Error of the Mean | 0.06 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.44 |
| Standard Error of the Mean |
| 0.04 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Point estimate ratio | 0.59 | Standard Error of the Mean | 0.05 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.36 |
| Standard Error of the Mean |
| 0.03 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Point estimate ratio | 0.53 | Standard Error of the Mean | 0.04 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.44 |
| Standard Error of the Mean |
| 0.02 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Point estimate ratio | 0.60 | Standard Error of the Mean | 0.03 | 2-Sided | Geometric means | Superiority or Other |
| >0.05 |
| Point estimate ratio |
| 0.78 |
| Standard Error of the Mean |
| 0.11 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | >0.05 | Point estimate ratio | 0.79 | Standard Error of the Mean | 0.11 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.73 |
| Standard Error of the Mean |
| 0.10 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | >0.05 | Point estimate ratio | 0.96 | Standard Error of the Mean | 0.13 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.70 |
| Standard Error of the Mean |
| 0.05 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Point estimate ratio | 0.85 | Standard Error of the Mean | 0.06 | 2-Sided | Geometric means | Superiority or Other |
| <0.05 |
| Point estimate ratio |
| 0.83 |
| Standard Error of the Mean |
| 0.06 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | >0.05 | Point estimate ratio | 0.86 | Standard Error of the Mean | 0.06 | 2-Sided | Geometric means | Superiority or Other |
| 0.05 |
| Mean Difference (Final Values) |
| -7548.05 |
| Standard Error of the Mean |
| 1542.93 |
| 2-Sided |
| Superiority or Other |
| Mixed Models Analysis | <0.05 | Mean Difference (Final Values) | -3854.86 | Standard Error of the Mean | 1533.95 | 2-Sided | Superiority or Other |
| <0.05 |
| Mean Difference (Final Values) |
| -1665.32 |
| Standard Error of the Mean |
| 696.97 |
| 2-Sided |
| Superiority or Other |
| Mixed Models Analysis | >0.05 | Mean Difference (Final Values) | -1520.39 | Standard Error of the Mean | 700.92 | 2-Sided | Superiority or Other |
| >0.05 |
| Point estimate ratio |
| 0.43 |
| Standard Error of the Mean |
| 0.34 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Mixed Models Analysis | >0.05 | Point estimate ratio | 1.05 | Standard Error of the Mean | 0.81 | 2-Sided | Geometric means | Superiority or Other |
| >0.05 |
| Point estimate ratio |
| 0.73 |
| Standard Error of the Mean |
| 0.88 |
| 2-Sided |
Geometric means |
| Superiority or Other |
| Regression, Linear | >0.05 | Point estimate ratio | 3.23 | Standard Error of the Mean | 3.84 | 2-Sided | Geometric means | Superiority or Other |