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| Name | Class |
|---|---|
| ProSciento, Inc. | INDUSTRY |
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This research study is being done to evaluate the effect of hepatic ultrasound insonification on whole-body insulin sensitivity and evaluate the safety and tolerability of hepatic ultrasound insonification in subjects with Type 2 Diabetes Mellitus (T2DM). "Insonify/insonification" is defined as applying to an area or an object carefully-controlled sound waves, typically as in ultrasound imaging. GE Research is sponsoring this research study. The purpose of this research study is to:
Insulin sensitivity refers to how sensitive the body's cells are in response to insulin.
Glucose tolerance refers to the body's ability to handle (tolerate) glucose. Insulin secretion is a process in which the body releases insulin in response to glucose levels in the blood becoming elevated.
The study device used in this study is cleared for use by the United States Food and Drug Administration (FDA) for ultrasound diagnostic exams, however it has not been tested or approved specifically for modulation of metabolism in people with diabetes. The use of the study device in this study is investigational and is considered a Non-Significant Risk (NSR).
This was an open label, exploratory pilot study to assess the effects of hepatic ultrasound insonification on glucometabolic parameters in subjects with T2DM through selective hepatic ultrasound of the porta hepatis region of the liver utilizing pulsed ultrasound. The study was to consist of 1 cohort comprising up to 15 subjects. Dropouts and withdrawals could have been replaced until the anticipated number of subjects completed the study. Finally, the study consisted of one cohort with 36 subjects enrolled, including 20 screen failures, 15 subjects that completed the study (1 completer had an incorrect infusion parameter and was removed from clamp analysis), and 1 subject that was discontinued at the discretion of the Investigator. As this was an exploratory, open-label study, no randomization or blinding was performed and no-unblinding codes were required.
The study included a Screening Period, Observational Period 1, 3 consecutive days of hepatic ultrasound insonification, and Observational Period 2. Each Observational Period was divided into an In-house Period and an Outpatient Visit (OPV). The Screening Period was performed up to 28 days prior to the first In-house Period. For eligible subjects with a body mass index (BMI) > 35.0 and ≤ 40.0 kg/m2 and/or a waist circumference > 40 and ≤ 45 inches, an ultrasound examination was added to confirm eligibility, and the Screening Period was extended to at least 30 days. The first Observational Period lasted approximately 2-weeks (Days -1 to 14). On the morning of Day -1, subjects checked into the clinic for a 3-day In-house Period; subjects may have been released from the clinic on Day 2. Subjects were contacted via telephone every other day until the next In-house Period. On Day 8, subjects checked into the clinic for an OPV. On Day 15, subjects checked into the clinic in fasting conditions for a 4-day In-house Period. Insonifications were performed on three consecutive days (Days 15, 16 and 17). Subjects may have been released from the clinic on Day 18. The second Observational Period lasted 11 days (Days 18 to 28). Subjects were contacted via telephone every other day until the Follow-up Visit. On Day 22, subjects checked into the clinic for the OPV. The Follow-up Visit was performed on Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insonification | Experimental | All subjects enrolled will receive a 3-day, 15 minute per day ultrasound insonification targeting the portis hepatis (liver). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic Ultrasound Insonification | Device | Hepatic ultrasound insonification will be performed after an overnight fast (no food or drinks except for water for at least 10 hours) at approximately the same time on each day for three days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Endogenous Glucose Production (EGP) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Insulin-Mediated EGP Suppression During the Clamp Timepoint With Low Rate Insulin Infusion (Step 1) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer For each clamp, the degree of EGP suppression from the fasting EGP value was to be determined during the last 30 minutes point during each step of the two-step H-E clamp using the following equation: % EGP suppression = 1 - (EGP clamp/EGP fasting) Partial suppression of EGP during Step 1 was to be assessed to determine hepatic insulin sensitivity and EGP suppression during Step 2 was to be measured to confirm that EGP was (near) fully suppressed to allow the determination of extrahepatic insulin sensitivity. | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Rate of Glucose Disappearance (Rd) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Day 2 (Baseline) to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Exploratory Biomarkers | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by exploratory markers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridgette Boggess Franey, MD | ProSciento, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9839117 | Background | Levy JC, Matthews DR, Hermans MP. Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 1998 Dec;21(12):2191-2. doi: 10.2337/diacare.21.12.2191. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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Of the 36 subjects enrolled into the screening visit, 16 subjects were enrolled into the study and 14 subjects completed the study for all outcomes. Of the 16 subjects enrolled, 1 subject discontinued the study at the discretion of the Investigator and 1 subject failed to complete only the clamp outcomes (i.e. completed all non-clamp outcomes) due to a clamp protocol deviation.
Of the 16 subjects enrolled, 3 subjects failed the initial screen and were rescreened at a later date.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Insonification Effect Population | The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 14 subjects. The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects. One subject had unevaluable data and was excluded from the Ultrasound Insonification Effect Population; however, the subject was included in the Safety Population. One subject had Step 1 of the Day 17 clamp extended by 60 minutes, per PI discretion, following a protocol deviation and was excluded from the Ultrasound Insonification Effect Population; however, the subject was included in the Safety Population. |
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| Overall Study |
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Demographic characteristics by subject for all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Insonification Effect Population | The Ultrasound Insonification Effect Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and completed the study for all outcomes (without being discontinued from the study at the discretion of the Investigator or failing to complete the clamp outcomes due to protocol deviation) and included 14 subjects. The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Posted | Mean | Standard Deviation | mg/kg/min per microU/ml | Day 2 (Baseline) to Day 17 |
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Assessing the safety and tolerability profile of hepatic ultrasound insonification in subjects with T2DM was an integral objective of this study; adverse event data was collected for study duration (Screening to Day 28).
TEAE was defined as any undesirable and unintended medical event occurring to a subject from the subject's first hepatic ultrasound insonification until post-treatment follow-up. The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
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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 | Safety Population | The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects (44.4%). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
The Safety Population consisted of subjects who received hepatic ultrasound insonification and included 16 subjects. The Ultrasound Insonification Effect Population consisted of subjects who received hepatic ultrasound insonification and included 15 subjects. Subject 101-029 had unevaluable data and was excluded from Ultrasound Insonification Effect Population. Subject 101-012 had clamp protocol deviation, and Ultrasound Insonification Effect Population was also analyzed excluding subject.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Minas | GE Research | (518)698-3959 | minas@ge.com |
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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 | Sep 24, 2020 | Nov 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2021 | Nov 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Screening to Day 28 |
| Incidence of Clinically Significant Laboratory Abnormalities | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Screening to Day 28 |
| Incidence of Significant Clinical Findings on Physical Examination | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Screening to Day 28 |
| Change From Baseline in Vital Signs: Blood Pressure | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Vital Signs: Pulse Rate | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Vital Signs: Respiratory Rate | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Vital Signs: Temperature | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Incidence of Clinically Significant Changes in Vital Sign Values | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Screening to Day 28 |
| Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Incidence of Clinically Significant Changes in ECG Measurements | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Screening to Day 28 |
| Change From Baseline in Insulin Sensitivity Index (SI) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer. The Insulin Sensitivity Index was to be calculated from the H-E clamp data using the formula included in the SAP, with Step 1 indicating the first phase of the clamp, or the period of administration of the first (lower) insulin infusion rate and Step 2 indicating the second phase of the clamp or the period of administration of the second (higher) insulin infusion rate. Mean GIRs and mean plasma insulin concentrations were to be calculated during steady state for the applicable step(s). Change from baseline of SI was then to be computed for each subject as: Change from baseline (SI) = SI2 - SI1, where Clamp 2 was the second clamp and Clamp 1 was the first clamp (completed on Day 2, prior to first insonification). | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Glucose Disposal Rate During Steady State (M) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Glucose Metabolic Clearance Rate During Steady State (MCR) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Day 2 (Baseline) to Day 17 |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a Homeostasis Model. A higher value denotes an increased level of insulin resistance, and a lower value denotes an decreased level of insulin resistance. The value is computed based on fasting insulin and glucose values. The HOMA2 results were produced by the HOMA2 calculator with FPG and insulin concentration obtained from safety laboratory assessments as the inputs to the calculator at https://www.dtu.ox.ac.uk/homacalculator/. Please see citation (see references module): "Levy 1998 Levy JC, Matthews DR, & Hermans MP. (1998). Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 21:2191-2192." | Day 15 (Baseline) to Day 18 |
| Change From Baseline in Homeostasis Model Assessment of Insulin Secretion (HOMA2-B) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a Homeostasis Model. The HOMA2 results were to be produced by the HOMA2 calculator with FPG and insulin concentration obtained from safety laboratory assessments as the inputs to the calculator at https://www.dtu.ox.ac.uk/homacalculator/. HOMA2-B values estimate steady state pancreatic beta cell function, as a percent of a normal reference population. See citation: "Levy JC, Matthews DR, & Hermans MP. (1998). Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 21:2191-2192." | Day 15 (Baseline) to Day 18 |
| Change From Baseline in Fasting Plasma Glucose (FPG) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by fasting plasma glucose blood test | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Glucose | To evaluate the effect of hepatic ultrasound insonification on change from baseline in glucose tolerance and insulin secretion, assessed by an oral glucose tolerance test (OGTT). AUC in this outcome is calculated using the absolute value of glucose measures (compared to incremental AUC below which uses baseline (time 0 glucose) subtracted values). | Day 1 (Baseline) to Day 16 |
| Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Insulin | To evaluate the effect of hepatic ultrasound insonification on change from baseline in glucose tolerance and insulin secretion, assessed by an oral glucose tolerance test (OGTT). AUC in this outcome is calculated using the absolute value of insulin measures (compared to incremental AUC below which uses baseline (time 0 insulin) subtracted values). | Day 1 (Baseline) to Day 16 |
| Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
| Change From Baseline in Continuous Glucose Monitoring System (CGMS): Average Daily Glucose | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
| Change From Baseline in Continuous Glucose Monitoring System (CGMS): Blood Glucose Coefficient of Variation | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
| Change From Baseline in Continuous Glucose Monitoring System (CGMS): Low/High Blood Glucose Index | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) To calculate the LBGI and HBGI, the original BG data for each day/period was to be transformed such that it was centered by zero and bound between -sqrt(10) and sqrt(10). f(BG,α,β) = [(ln(BG))1.084 - 5.381]*1.509 The transformed values were then to be input into the BG risk function: r(BG) = 10 * f(BG,α,β)2 The risk of each observation was further to be transformed into two series, risk of low BG series, rl(BG), and risk of high BG series, rh(BG): rl(BG) = r(BG) if f(BG) < 0 and 0 otherwise rh(BG) = r(BG) if f(BG) > 0 and 0 otherwise These series were then to be averaged to produce the LBGI and the HBGI as shown in the equations in the SAP. | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
| Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Screening to Day 28 |
| Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Screening to Day 28 |
| Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Screening to Day 28 |
| Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Screening to Day 28 |
| Change From Baseline in Long-term Glucose Parameters: Fructosamine |
To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples |
| Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Long-term Glucose Parameters: Hemoglobin A1C | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Lipid Metabolism Parameters: Free Fatty Acids | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Inflammatory Biomarkers: Adiponectin | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Inflammatory Biomarkers: C Reactive Protein | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
| Change From Baseline in Inflammatory Biomarkers: Interleukin-6 | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Primary | Change From Baseline in Endogenous Glucose Production (EGP) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Posted | Mean | Standard Deviation | mg/kg/min | Day 2 (Baseline) to Day 17 |
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| Primary | Change From Baseline in Insulin-Mediated EGP Suppression During the Clamp Timepoint With Low Rate Insulin Infusion (Step 1) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer For each clamp, the degree of EGP suppression from the fasting EGP value was to be determined during the last 30 minutes point during each step of the two-step H-E clamp using the following equation: % EGP suppression = 1 - (EGP clamp/EGP fasting) Partial suppression of EGP during Step 1 was to be assessed to determine hepatic insulin sensitivity and EGP suppression during Step 2 was to be measured to confirm that EGP was (near) fully suppressed to allow the determination of extrahepatic insulin sensitivity. | Posted | Mean | Standard Deviation | percent suppression | Day 2 (Baseline) to Day 17 |
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| Primary | Change From Baseline in Rate of Glucose Disappearance (Rd) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Posted | Mean | Standard Deviation | mg/kg/min | Day 2 (Baseline) to Day 17 |
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| Secondary | Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Posted | Count of Participants | Participants | Screening to Day 28 |
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| Secondary | Incidence of Clinically Significant Laboratory Abnormalities | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Number | clinically significant lab abnormalities | Screening to Day 28 |
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| Secondary | Incidence of Significant Clinical Findings on Physical Examination | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Number | clinically significant phys exam finding | Screening to Day 28 |
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| Secondary | Change From Baseline in Vital Signs: Blood Pressure | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Change From Baseline in Vital Signs: Pulse Rate | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | beats/minute | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Change From Baseline in Vital Signs: Respiratory Rate | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | breaths/minute | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Change From Baseline in Vital Signs: Temperature | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | degrees C | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Incidence of Clinically Significant Changes in Vital Sign Values | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | clinically significant changes | Screening to Day 28 |
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| Secondary | Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | msec | Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Incidence of Clinically Significant Changes in ECG Measurements | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM | Posted | Mean | Standard Deviation | clinically significant changes | Screening to Day 28 |
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| Secondary | Change From Baseline in Insulin Sensitivity Index (SI) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer. The Insulin Sensitivity Index was to be calculated from the H-E clamp data using the formula included in the SAP, with Step 1 indicating the first phase of the clamp, or the period of administration of the first (lower) insulin infusion rate and Step 2 indicating the second phase of the clamp or the period of administration of the second (higher) insulin infusion rate. Mean GIRs and mean plasma insulin concentrations were to be calculated during steady state for the applicable step(s). Change from baseline of SI was then to be computed for each subject as: Change from baseline (SI) = SI2 - SI1, where Clamp 2 was the second clamp and Clamp 1 was the first clamp (completed on Day 2, prior to first insonification). | Posted | Mean | Standard Deviation | ml/min per microU/ml | Day 2 (Baseline) to Day 17 |
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| Secondary | Change From Baseline in Glucose Disposal Rate During Steady State (M) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Posted | Mean | Standard Deviation | mg/kg/min | Day 2 (Baseline) to Day 17 |
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| Secondary | Change From Baseline in Glucose Metabolic Clearance Rate During Steady State (MCR) | To evaluate the effect of hepatic ultrasound insonification on changes from baseline in whole-body insulin sensitivity during a two-step hyperinsulinemic, euglycemic clamp with stable isotope labeled glucose tracer | Posted | Mean | Standard Deviation | dL/kg/min | Day 2 (Baseline) to Day 17 |
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| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a Homeostasis Model. A higher value denotes an increased level of insulin resistance, and a lower value denotes an decreased level of insulin resistance. The value is computed based on fasting insulin and glucose values. The HOMA2 results were produced by the HOMA2 calculator with FPG and insulin concentration obtained from safety laboratory assessments as the inputs to the calculator at https://www.dtu.ox.ac.uk/homacalculator/. Please see citation (see references module): "Levy 1998 Levy JC, Matthews DR, & Hermans MP. (1998). Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 21:2191-2192." | Posted | Mean | Standard Deviation | score on a scale | Day 15 (Baseline) to Day 18 |
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| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Secretion (HOMA2-B) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a Homeostasis Model. The HOMA2 results were to be produced by the HOMA2 calculator with FPG and insulin concentration obtained from safety laboratory assessments as the inputs to the calculator at https://www.dtu.ox.ac.uk/homacalculator/. HOMA2-B values estimate steady state pancreatic beta cell function, as a percent of a normal reference population. See citation: "Levy JC, Matthews DR, & Hermans MP. (1998). Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 21:2191-2192." | Posted | Mean | Standard Deviation | score on a scale | Day 15 (Baseline) to Day 18 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by fasting plasma glucose blood test | Posted | Mean | Standard Deviation | mg/dL | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Secondary | Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Glucose | To evaluate the effect of hepatic ultrasound insonification on change from baseline in glucose tolerance and insulin secretion, assessed by an oral glucose tolerance test (OGTT). AUC in this outcome is calculated using the absolute value of glucose measures (compared to incremental AUC below which uses baseline (time 0 glucose) subtracted values). | Posted | Mean | Standard Deviation | (mg hr)/dL | Day 1 (Baseline) to Day 16 |
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| Secondary | Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Insulin | To evaluate the effect of hepatic ultrasound insonification on change from baseline in glucose tolerance and insulin secretion, assessed by an oral glucose tolerance test (OGTT). AUC in this outcome is calculated using the absolute value of insulin measures (compared to incremental AUC below which uses baseline (time 0 insulin) subtracted values). | Posted | Mean | Standard Deviation | (mU hr)/L | Day 1 (Baseline) to Day 16 |
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| Secondary | Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | Posted | Mean | Standard Deviation | % Time in Ranges | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
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| Secondary | Change From Baseline in Continuous Glucose Monitoring System (CGMS): Average Daily Glucose | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | Posted | Mean | Standard Deviation | mg/dL | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
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| Secondary | Change From Baseline in Continuous Glucose Monitoring System (CGMS): Blood Glucose Coefficient of Variation | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) | Posted | Mean | Standard Deviation | % Coefficient of Variation | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
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| Secondary | Change From Baseline in Continuous Glucose Monitoring System (CGMS): Low/High Blood Glucose Index | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS) To calculate the LBGI and HBGI, the original BG data for each day/period was to be transformed such that it was centered by zero and bound between -sqrt(10) and sqrt(10). f(BG,α,β) = [(ln(BG))1.084 - 5.381]*1.509 The transformed values were then to be input into the BG risk function: r(BG) = 10 * f(BG,α,β)2 The risk of each observation was further to be transformed into two series, risk of low BG series, rl(BG), and risk of high BG series, rh(BG): rl(BG) = r(BG) if f(BG) < 0 and 0 otherwise rh(BG) = r(BG) if f(BG) > 0 and 0 otherwise These series were then to be averaged to produce the LBGI and the HBGI as shown in the equations in the SAP. | Posted | Mean | Standard Deviation | Blood Glucose Index | 14:00 on Day -1 to 22:00 on Day 1 (Baseline) to 14:00 on Day 15 to 22:00 on Day 16 - omitting data collected between a subject's OGTT glucose consumption start time + 180 minutes |
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| Secondary | Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Posted | Count of Participants | Participants | Screening to Day 28 |
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| Secondary | Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Posted | Count of Participants | Participants | Screening to Day 28 |
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| Secondary | Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Posted | Count of Participants | Participants | Screening to Day 28 |
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| Secondary | Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term | To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM. Incidence of adverse device effects included observations of Incidence and severity of clinically significant laboratory abnormalities, Change from baseline in vital signs (blood pressure, temperature, respiratory rate, and heart rate), Incidence and severity of clinical findings on physical examination, Change from baseline in 12-lead electrocardiogram (ECG) parameters; the primary ECG endpoint was QTcF. To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM: [Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death] | Posted | Count of Participants | Participants | Screening to Day 28 |
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| Other Pre-specified | Change From Baseline in Exploratory Biomarkers | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by exploratory markers in blood samples | Posted | Mean | Standard Deviation | ng/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Long-term Glucose Parameters: Fructosamine | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples | Posted | Mean | Standard Deviation | micromol/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Long-term Glucose Parameters: Hemoglobin A1C | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples | Posted | Mean | Standard Deviation | % A1C | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples | Posted | Mean | Standard Deviation | mg/dL | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Lipid Metabolism Parameters: Free Fatty Acids | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples | Posted | Mean | Standard Deviation | mEq/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Inflammatory Biomarkers: Adiponectin | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Posted | Mean | Standard Deviation | mg/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Inflammatory Biomarkers: C Reactive Protein | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Posted | Mean | Standard Deviation | mg/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| Other Pre-specified | Change From Baseline in Inflammatory Biomarkers: Interleukin-6 | To evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples | Posted | Mean | Standard Deviation | ng/L | Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonification |
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| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Infusion site haemorrhage | General disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Vessel puncture site swelling | General disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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| Thrombophlebitis | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment | The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study. |
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Not provided
| D004700 | Endocrine System Diseases |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Gastrointestinal disorders |
|
| Abdominal pain |
|
| Dyspepsia |
|
| Vomiting |
|
| General disorders and administration site conditions |
|
| Infusion site hemorrhage |
|
| Vessel puncture site swelling |
|
| Metabolism and nutrition disorders |
|
| Hypoglycaemia |
|
| Nervous system disorders |
|
| Dizziness |
|
| Vascular disorders |
|
| Thrombophlebitis |
|
| Treatment Emergent Adverse Device Effect (TEADE) |
|
| TEADE Related to Study Procedure |
|
| Serious TEADE |
|
| TEADE Leading to Study Discontinuation |
|
| Unanticipated Adverse Device Effect (UADE) |
|
|
| Number of Clinically Significant Changes in Renal Function Laboratory Values |
|
| Number of Clinically Significant Changes in Urinalysis Laboratory Values |
|
|
| Change from Baseline in RR Interval |
|
| Change from Baseline in QTcF Interval |
|
| Title | Measurements |
|---|---|
|
| Time <70 mg/dL |
|
| Time <54 mg/dL |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Gastrointestinal disorders |
|
| Abdominal pain |
|
| Dyspepsia |
|
| Vomiting |
|
| General disorders and administration site conditions |
|
| Infusion site hemorrhage |
|
| Vessel puncture site swelling |
|
| Metabolism and nutrition disorders |
|
| Hypoglycaemia |
|
| Nervous system disorders |
|
| Dizziness |
|
| Vascular disorders |
|
| Thrombophlebitis |
|
| Treatment Emergent Adverse Device Effect (TEADE) |
|
| TEADE Related to Study Procedure |
|
| Serious TEADE |
|
| TEADE Leading to Study Discontinuation |
|
| Unanticipated Adverse Device Effect (UADE) |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Gastrointestinal disorders |
|
| Abdominal pain |
|
| Dyspepsia |
|
| Vomiting |
|
| General disorders and administration site conditions |
|
| Infusion site hemorrhage |
|
| Vessel puncture site swelling |
|
| Metabolism and nutrition disorders |
|
| Hypoglycaemia |
|
| Nervous system disorders |
|
| Dizziness |
|
| Vascular disorders |
|
| Thrombophlebitis |
|
| Treatment Emergent Adverse Device Effect (TEADE) |
|
| TEADE Related to Study Procedure |
|
| Serious TEADE |
|
| TEADE Leading to Study Discontinuation |
|
| Unanticipated Adverse Device Effect (UADE) |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Gastrointestinal disorders |
|
| Abdominal pain |
|
| Dyspepsia |
|
| Vomiting |
|
| General disorders and administration site conditions |
|
| Infusion site hemorrhage |
|
| Vessel puncture site swelling |
|
| Metabolism and nutrition disorders |
|
| Hypoglycaemia |
|
| Nervous system disorders |
|
| Dizziness |
|
| Vascular disorders |
|
| Thrombophlebitis |
|
| Treatment Emergent Adverse Device Effect (TEADE) |
|
| TEADE Related to Study Procedure |
|
| Serious TEADE |
|
| TEADE Leading to Study Discontinuation |
|
| Unanticipated Adverse Device Effect (UADE) |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Gastrointestinal disorders |
|
| Abdominal pain |
|
| Dyspepsia |
|
| Vomiting |
|
| General disorders and administration site conditions |
|
| Infusion site hemorrhage |
|
| Vessel puncture site swelling |
|
| Metabolism and nutrition disorders |
|
| Hypoglycaemia |
|
| Nervous system disorders |
|
| Dizziness |
|
| Vascular disorders |
|
| Thrombophlebitis |
|
| Treatment Emergent Adverse Device Effect (TEADE) |
|
| TEADE Related to Study Procedure |
|
| Serious TEADE |
|
| TEADE Leading to Study Discontinuation |
|
| Unanticipated Adverse Device Effect (UADE) |
|
| Title | Measurements |
|---|---|
|
| Leptin |
|
|
| Change from Baseline in VLDL Cholesterol |
|
| Change from Baseline in Triglycerides |
|