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| Name | Class |
|---|---|
| Veterans Medical Research Foundation | OTHER |
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This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar.
The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen) that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy. Insulin resistance is the condition in which higher than normal amounts of insulin are necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of insulin produced by the body and released in the blood. Glucagon is a hormone (chemical substance produced by the pancreas gland in the body) which increases blood glucose.
This was a Phase 2, double-blinded, single-center study to assess the effects of pasireotide on insulin secretion and glucose metabolism in healthy male volunteers. Subjects who had given written informed consent and had been shown to satisfy the inclusion and exclusion criteria underwent baseline tests. An oral glucose tolerance test (OGTT) was administered on Day 1. If the OGTT results confirmed normal glycemia, the subject continued with baseline testing on Day 2 (2-step hyperglycemic clamp test with arginine stimulation) and Day 3 (2-step hyperinsulinemic euglycemic clamp (HEC) test with [3-3H]glucose). Each subject was then randomized into 1 of 3 dose groups: 600 µg twice daily (bid) delivered subcutaneously , pasireotide 900 µg bid delivered subcutaneously, or pasireotide 1200 µg bid delivered subcutaneously. Subcutaneous injections of pasireotide were given twice daily from Days 3-10 (for 8 consecutive days, starting from the evening of Day 3 and up to the morning injection on Day 10). On Study Days 8-10, the last 3 days of treatment with the pasireotide injections, the tests performed at Baseline (ie, the OGTT; the 2-step hyperglycemic clamp test with arginine stimulation; and the 2-step HEC test with [3-3H] glucose) were repeated. Subjects returned for a post-study safety follow-up visit 5 to 7 days after the last injection of the study drug and an H&P and safety labs (including a fasting glucose level) was performed. In addition, depending on subject convenience, a 3rd OGTT was either performed on this visit or was performed on another occasion convenient for subjects, in order to confirm that subjects' OGTT status had returned to baseline levels.
This additional post-study OGTT was added in a protocol amendment. Those subjects who completed the clinical trial and the follow-up visit before the amendment was approved were contacted and asked to return for another follow-up visit. The optional post-study OGTT was voluntary and subjects could choose not to participate. In order to reduce the severity of gastrointestinal adverse events (AEs), the protocol was amended (while keeping the blind intact) on 08 December 2009 to discontinue the pasireotide 1200 µg bid arm. The randomization scheme was subsequently adjusted to assign subjects in a 1:1 ratio to the 2 remaining arms: pasireotide 600 µg bid and pasireotide 900 µg bid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide 600 µg sc bid | Experimental | n=19. Pasireotide 600 µg sc bid |
|
| Pasireotide 900 µg sc bid | Experimental | n=19. Pasireotide 900 µg sc bid |
|
| Pasireotide 1200 µg sc bid | Experimental | n=7. Due to increased severity of gastro-intestinal side effects, this arm was discontinued. These participants were only included in the safety analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pasireotide | Drug | Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Basal Level | Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation) | -30 min and -15 min on Day 2 and Day 9 |
| Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp | Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2. | 0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9) |
| Change in Basal Endogenous Glucose Production (EGP) | Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp) | Day 3 and Day 10 |
| Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition | Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp) | Day 3 and Day 10 |
| Change in High Dose % Endogenous Glucose Production (EGP) Inhibition | Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp) | Day 3 and Day 10 |
| Change in Low-Dose Glucose Disposal Rate (GDR) | Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose Level | An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed. | -30 minutes on Day 1 and -30 minutes on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Henry, MD | Veterans Medical Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMR Center for Metabolic Research VASDHS | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23733372 | Result | Henry RR, Ciaraldi TP, Armstrong D, Burke P, Ligueros-Saylan M, Mudaliar S. Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. J Clin Endocrinol Metab. 2013 Aug;98(8):3446-53. doi: 10.1210/jc.2013-1771. Epub 2013 Jun 3. |
| Label | URL |
|---|---|
| Study site Web site | View source |
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Participants were excluded if they had a family history of diabetes or a baseline diagnosis of impaired glucose tolerance.
Participants were healthy men aged 18-50 years with a body mass index (BMI) ≤25 kg/m2 who came to the VA San Diego Healthcare System Metabolic Research medical clinic. Recruitment occurred between August of 2009 until March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pasireotide 600 μg sc Bid | 19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study. |
| FG001 | Pasireotide 900 μg sc Bid | 19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study. |
| FG002 | Pasireotide 1200 μg sc Bid | 7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Nondiabetic males, aged 18-50 years with body mass index (BMI) ≤ 25. Subjects were not to have any family history of diabetes and no diagnosis of impaired glucose tolerance or gallstone disease.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pasireotide 600 μg sc Bid | Pasireotide 600 μg sc bid n=19 |
| BG001 | Pasireotide 900 μg sc Bid | Pasireotide 900 μg sc bid n=19 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Fasting Plasma Glucose Level | An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed. | Posted | Mean | Standard Deviation | mmol/L | -30 minutes on Day 1 and -30 minutes on Day 8 |
|
Adverse events (AE) were collected in real time as reported by each study subject. The study Investigators' reviewed and evaluated each individually reported Adverse Event within one week of reporting (if not immediately upon report).
The investigator provided a listing of each subject's AEs. The individual AEs that occurred in each subject were then identified using the Investigator's term and AE frequency was summarized by dose group and adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pasireotide 600 μg sc Bid | Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | 10 subjects (53.6%) in the 600 µg sc bid arm. 10 subjects (53.6%) in the 900 µg sc bid arm. 5 subjects (71.4%) in the 1200 µg sc bid arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Veterans Medical Research Foundation | 858-552-8585 | rrhenry@ucsd.edu |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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|
| Day 3 and Day 10 |
| Change in High-Dose Glucose Disposal Rate (GDR) | Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp. | Day 3 and Day 10 |
| Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) |
Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1. |
| 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8) |
| Change Fasting Plasma Insulin Level | An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed. | -30 minutes on Day 1 and -30 minutes on Day 8 |
| Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) | Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1 | 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Nondiabetic males, aged 18-50 years with body mass index (BMI) ≤ 25. Subjects were not to have any family history of diabetes and no diagnosis of impaired glucose tolerance or gallstone disease. | Count of Participants | Participants |
|
| Body Mass Index BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
|
|
|
| Secondary | Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) | Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1. | Posted | Mean | Standard Deviation | h*mmol/L | 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8) |
|
|
|
|
| Secondary | Change Fasting Plasma Insulin Level | An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed. | Posted | Mean | Standard Deviation | pmol/L | -30 minutes on Day 1 and -30 minutes on Day 8 |
|
|
|
|
| Secondary | Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) | Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1 | Posted | Mean | Standard Deviation | h*pmol/L | 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8) |
|
|
|
|
| Primary | Change in Insulin Basal Level | Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation) | Posted | Mean | Standard Deviation | pmol/L | -30 min and -15 min on Day 2 and Day 9 |
|
|
|
|
| Primary | Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp | Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2. | Posted | Mean | Standard Deviation | h*pmol/L | 0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9) |
|
|
|
|
| Primary | Change in Basal Endogenous Glucose Production (EGP) | Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp) | Posted | Mean | Standard Deviation | mg/kg/min | Day 3 and Day 10 |
|
|
|
|
| Primary | Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition | Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp) | Posted | Mean | Standard Deviation | percentage of EGP Inhibition | Day 3 and Day 10 |
|
|
|
|
| Primary | Change in High Dose % Endogenous Glucose Production (EGP) Inhibition | Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp) | Posted | Mean | Standard Deviation | percentage of EGP inhibition | Day 3 and Day 10 |
|
|
|
|
| Primary | Change in Low-Dose Glucose Disposal Rate (GDR) | Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp. | Posted | Mean | Standard Deviation | mg/kg/min | Day 3 and Day 10 |
|
|
|
|
| Primary | Change in High-Dose Glucose Disposal Rate (GDR) | Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp. | Posted | Mean | Standard Deviation | mg/kg/min | Day 3 and Day 10 |
|
|
|
|
| 0 |
| 19 |
| 18 |
| 19 |
| EG001 | Pasireotide 900 μg sc Bid | Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. | 0 | 19 | 18 | 19 |
| EG002 | Pasireotide 1200 μg sc Bid | Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. | 0 | 7 | 7 | 7 |
|
| Abdominal Cramping | Gastrointestinal disorders | Non-systematic Assessment | 6 subjects (31.6%) in the 600 µg sc bid arm. 9 subjects (47.4%) in the 900 µg sc bid arm. 4 subjects (57.1%) in the 1200 µg sc bid arm. |
|
| Loose Stools (soft stools) | Gastrointestinal disorders | Non-systematic Assessment | 5 subjects (26.3%) in the 600 µg sc bid arm. 13 subjects (68.4%) in the 900 µg sc bid arm. 2 subjects (28.6%) in the 1200 µg sc bid arm. |
|
| Burning Sensation | Gastrointestinal disorders | Non-systematic Assessment | 4 subjects (21.1%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm. |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | 3 subjects (15.8%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm. 1 subjects (14.3%) in the 1200 µg sc bid arm. |
|
| Fatigue | General disorders | Non-systematic Assessment | 3 subjects (15.8%) in the 600 µg sc bid arm. 1 subject (14.3%) in the 1200 µg sc bid arm. |
|
| Vomiting/emesis | Gastrointestinal disorders | Non-systematic Assessment | 2 subjects (10.5%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. 3 subjects (42.8%) in the 1200 µg sc bid arm. |
|
| Gas (Flatulence) | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm. |
|
| Injection site redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm. |
|
| Injection site stinging | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm. |
|
| Upper respiratory infection (common cold) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. |
|
| Frequent Stools | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Impacted wisdom tooth | General disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Light colored stool | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Pressure in gut | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Stomach ache | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Stomach cramps | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 900 µg sc bid arm. |
|
| Stomach fullness | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 600 µg sc bid arm. |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment | 1 subject (5.3%) in the 900 µg sc bid arm. |
|
| Injection site bruise | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 1 subject (5.3%) in the 900 µg sc bid arm. |
|
| Sleepiness | General disorders | Non-systematic Assessment | 1 subject (5.3%) in the 900 µg sc bid arm. |
|
| Dizziness | General disorders | Non-systematic Assessment | 1 subject (14.3%) in the 1200 µg sc bid arm. |
|
| Histamine-like reaction | General disorders | Non-systematic Assessment | 1 subject (14.3%) in the 1200 µg sc bid arm. |
|
| Sweating | General disorders | Non-systematic Assessment | 1 subject (14.3%) in the 1200 µg sc bid arm. |
|
| Vasovagal reaction while voiding | General disorders | Non-systematic Assessment | 2 subjects (10.5%) in the 900 µg sc bid arm. |
|
| Infiltration, left ACFf | Injury, poisoning and procedural complications | Non-systematic Assessment | Procedural complication: 1 subject (5.3%) in the 900 µg sc bid arm. |
|
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| AUC 0-180 min |
|
| ANOVA |
| <0.001 |
Two sided P Value. |
| 2-Sided |
| No |
| Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P Value | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| <0.001 |
Two sided P value. |
| 2-Sided |
| No |
| Superiority or Other |
| AUC 0-180 min |
|
| ANOVA |
| <0.001 |
Two sided P value |
| 2-Sided |
| No |
| Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| <0.001 |
Two sided P value |
| 2-Sided |
| No |
| Superiority or Other |
| AUC 0-180 min |
|
| ANOVA |
| <0.001 |
Two sided P value |
| 2-Sided |
| No |
| Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P value | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes | ANOVA | <0.001 | Two sided P value | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes | ANOVA | <0.001 | Two sided P value. | 2-Sided | No | Superiority or Other |
| 0.132 |
Two sided P value. |
| 2-Sided |
| No |
| Superiority or Other |
| 0.111 |
Two sided P value. |
| 2-Sided |
| No |
| Superiority or Other |
| 0.125 |
Two sided P value. |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA |
| 0.956 |
Two sided P value. |
| 2-Sided |
| No |
| Superiority or Other |