Trial Outcomes & Findings for Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM (NCT NCT04502212)
NCT ID: NCT04502212
Last Updated: 2022-06-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Day 2 (Baseline) to Day 17
Results posted on
2022-06-02
Participant Flow
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Unevaluable data; excluded from Ultrasound Insonification Effect Pop; included in Safety Pop
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1
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Overall Study
Clamp protocol deviation; excluded from Ultrasound Insonification Effect Pop; included in Safety Pop
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1
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Baseline Characteristics
Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM
Baseline characteristics by cohort
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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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Age, Continuous
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61.9 years
STANDARD_DEVIATION 5.39 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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10 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
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|---|---|
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Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I)
Clamp Timepoint with Low Rate Insulin Infusion (Step 1)
|
0.055 mg/kg/min per microU/ml
Standard Deviation 0.0932
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Change From Baseline in Glucose Disposal Rate: Insulin Ratio During Steady State (M/I)
Clamp Timepoint with High Rate Insulin Infusion (Step 2)
|
0.004 mg/kg/min per microU/ml
Standard Deviation 0.0161
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PRIMARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
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Change From Baseline in Endogenous Glucose Production (EGP)
Clamp Timepoint prior to Insulin Infusion (Fasting)
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-0.004 mg/kg/min
Standard Deviation 0.2316
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Change From Baseline in Endogenous Glucose Production (EGP)
Clamp Timepoint with Low Rate Insulin Infusion (Step 1)
|
-0.169 mg/kg/min
Standard Deviation 0.4849
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PRIMARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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.
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
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Change From Baseline in Insulin-Mediated EGP Suppression During the Clamp Timepoint With Low Rate Insulin Infusion (Step 1)
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10.06 percent suppression
Standard Deviation 25.294
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PRIMARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
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Change From Baseline in Rate of Glucose Disappearance (Rd)
Clamp Timepoint prior to Insulin Infusion (Fasting)
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-0.004 mg/kg/min
Standard Deviation 0.2316
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Change From Baseline in Rate of Glucose Disappearance (Rd)
Clamp Timepoint with Low Rate Insulin Infusion (Step 1)
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0.663 mg/kg/min
Standard Deviation 1.6645
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Change From Baseline in Rate of Glucose Disappearance (Rd)
Clamp Timepoint with High Rate Insulin Infusion (Step 2)
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1.029 mg/kg/min
Standard Deviation 3.2130
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SECONDARY outcome
Timeframe: Screening to Day 28To 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: \[Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death\]
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Subjects with at least one Treatment Emergent Adverse Event (TEAE)
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7 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Skin and subcutaneous tissue disorders
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3 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Ecchymosis
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2 Participants
|
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Erythema
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1 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Gastrointestinal disorders
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2 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Abdominal pain
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dyspepsia
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vomiting
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
General disorders and administration site conditions
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2 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Infusion site hemorrhage
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vessel puncture site swelling
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Metabolism and nutrition disorders
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1 Participants
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|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Hypoglycaemia
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1 Participants
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|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Nervous system disorders
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dizziness
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vascular disorders
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Thrombophlebitis
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1 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Treatment Emergent Adverse Device Effect (TEADE)
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0 Participants
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|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Related to Study Procedure
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0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Serious TEADE
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0 Participants
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Leading to Study Discontinuation
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0 Participants
|
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Incidence of Adverse Device Effects (ADEs) With a Severity Score of 1: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Unanticipated Adverse Device Effect (UADE)
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0 Participants
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SECONDARY outcome
Timeframe: Screening to Day 28To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Incidence of Clinically Significant Laboratory Abnormalities
Number of Clinically Significant Lab Abnormalities
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0 clinically significant lab abnormalities
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Incidence of Clinically Significant Laboratory Abnormalities
Number of Clinically Significant Changes in Hematology Laboratory Values
|
0 clinically significant lab abnormalities
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Incidence of Clinically Significant Laboratory Abnormalities
Number of Clinically Significant Changes in Hepatic Function Laboratory Values
|
0 clinically significant lab abnormalities
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Incidence of Clinically Significant Laboratory Abnormalities
Number of Clinically Significant Changes in Renal Function Laboratory Values
|
0 clinically significant lab abnormalities
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Incidence of Clinically Significant Laboratory Abnormalities
Number of Clinically Significant Changes in Urinalysis Laboratory Values
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0 clinically significant lab abnormalities
|
SECONDARY outcome
Timeframe: Screening to Day 28To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Incidence of Significant Clinical Findings on Physical Examination
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0 clinically significant phys exam finding
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SECONDARY outcome
Timeframe: Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Change From Baseline in Vital Signs: Blood Pressure
Change from Baseline in Systolic Blood Pressure
|
-3.4 mmHg
Standard Deviation 10.89
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Change From Baseline in Vital Signs: Blood Pressure
Change from Baseline in Diastolic Blood Pressure
|
-3.0 mmHg
Standard Deviation 5.06
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SECONDARY outcome
Timeframe: Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Change From Baseline in Vital Signs: Pulse Rate
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-1.9 beats/minute
Standard Deviation 10.62
|
SECONDARY outcome
Timeframe: Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Change From Baseline in Vital Signs: Respiratory Rate
|
-1.0 breaths/minute
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Change From Baseline in Vital Signs: Temperature
|
0.07 degrees C
Standard Deviation 0.531
|
SECONDARY outcome
Timeframe: Screening to Day 28To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Incidence of Clinically Significant Changes in Vital Sign Values
|
0 clinically significant changes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline to Day 28 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Change from Baseline in QT Interval
|
4.6 msec
Standard Deviation 20.84
|
|
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Change from Baseline in PR Interval
|
-1.8 msec
Standard Deviation 15.26
|
|
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Change from Baseline in QRS Interval
|
1.1 msec
Standard Deviation 6.01
|
|
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Change from Baseline in RR Interval
|
12.4 msec
Standard Deviation 99.99
|
|
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Change from Baseline in QTcF Interval
|
2.4 msec
Standard Deviation 11.83
|
SECONDARY outcome
Timeframe: Screening to Day 28To evaluate safety and tolerability of hepatic ultrasound insonification in subjects with T2DM
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
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Incidence of Clinically Significant Changes in ECG Measurements
|
0 clinically significant changes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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).
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
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|---|---|
|
Change From Baseline in Insulin Sensitivity Index (SI)
|
-0.000 ml/min per microU/ml
Standard Deviation 0.0132
|
SECONDARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
|
|---|---|
|
Change From Baseline in Glucose Disposal Rate During Steady State (M)
Clamp Timepoint with Low Rate Insulin Infusion (Step 1)
|
0.87 mg/kg/min
Standard Deviation 1.623
|
|
Change From Baseline in Glucose Disposal Rate During Steady State (M)
Clamp Timepoint with High Rate Insulin Infusion (Step 2)
|
1.04 mg/kg/min
Standard Deviation 3.161
|
SECONDARY outcome
Timeframe: Day 2 (Baseline) to Day 17To 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
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=14 Participants
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.
|
|---|---|
|
Change From Baseline in Glucose Metabolic Clearance Rate During Steady State (MCR)
Clamp Timepoint with Low Rate Insulin Infusion (Step 1)
|
0.81 dL/kg/min
Standard Deviation 1.458
|
|
Change From Baseline in Glucose Metabolic Clearance Rate During Steady State (MCR)
Clamp Timepoint with High Rate Insulin Infusion (Step 2)
|
0.90 dL/kg/min
Standard Deviation 3.501
|
SECONDARY outcome
Timeframe: Day 15 (Baseline) to Day 18To 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."
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
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|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR)
|
-0.81 score on a scale
Standard Deviation 1.018
|
SECONDARY outcome
Timeframe: Day 15 (Baseline) to Day 18To 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."
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Homeostasis Model Assessment of Insulin Secretion (HOMA2-B)
|
-15.92 score on a scale
Standard Deviation 24.132
|
SECONDARY outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by fasting plasma glucose blood test
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-3.0 mg/dL
Standard Deviation 20.87
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 16To 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).
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Glucose
Plasma Glucose Total AUC
|
-2.112 (mg hr)/dL
Standard Deviation 86.2483
|
|
Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Glucose
Plasma Glucose Incremental AUC
|
-0.720 (mg hr)/dL
Standard Deviation 68.7508
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 16To 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).
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Insulin
Insulin Total AUC
|
13.580 (mU hr)/L
Standard Deviation 32.2072
|
|
Change From Baseline in Oral Glucose Tolerance Test (OGTT) Area Under the Curve (AUC 0-180): Insulin
Insulin Incremental AUC
|
11.777 (mU hr)/L
Standard Deviation 24.1236
|
SECONDARY outcome
Timeframe: 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 minutesTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS)
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges
Time >250 mg/dL
|
-1.80 % Time in Ranges
Standard Deviation 8.376
|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges
Time >180 mg/dL
|
-0.90 % Time in Ranges
Standard Deviation 12.869
|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges
Time 70-180 mg/dL
|
0.90 % Time in Ranges
Standard Deviation 12.869
|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges
Time <70 mg/dL
|
-0.00 % Time in Ranges
Standard Deviation 0.000
|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Time in Ranges
Time <54 mg/dL
|
-0.00 % Time in Ranges
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: 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 minutesTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS)
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Average Daily Glucose
|
-4.807 mg/dL
Standard Deviation 17.0274
|
SECONDARY outcome
Timeframe: 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 minutesTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, assessed by a continuous glucose monitoring system (CGMS)
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Blood Glucose Coefficient of Variation
|
-1.58 % Coefficient of Variation
Standard Deviation 3.858
|
SECONDARY outcome
Timeframe: 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 minutesTo 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.
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Low/High Blood Glucose Index
Low Blood Glucose Index (LBGI)
|
-0.02 Blood Glucose Index
Standard Deviation 0.056
|
|
Change From Baseline in Continuous Glucose Monitoring System (CGMS): Low/High Blood Glucose Index
High Blood Glucose Index (HBGI)
|
-0.85 Blood Glucose Index
Standard Deviation 2.951
|
SECONDARY outcome
Timeframe: Screening to Day 28To 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: \[Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death\]
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Subjects with at least one Treatment Emergent Adverse Event (TEAE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Skin and subcutaneous tissue disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Ecchymosis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Erythema
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Gastrointestinal disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Abdominal pain
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dyspepsia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vomiting
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
General disorders and administration site conditions
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Infusion site hemorrhage
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vessel puncture site swelling
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Metabolism and nutrition disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Hypoglycaemia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Nervous system disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dizziness
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vascular disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Thrombophlebitis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Treatment Emergent Adverse Device Effect (TEADE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Related to Study Procedure
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Serious TEADE
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Leading to Study Discontinuation
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 2: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening to Day 28To 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: \[Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death\]
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Subjects with at least one Treatment Emergent Adverse Event (TEAE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Skin and subcutaneous tissue disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Ecchymosis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Erythema
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Gastrointestinal disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Abdominal pain
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dyspepsia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vomiting
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
General disorders and administration site conditions
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Infusion site hemorrhage
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vessel puncture site swelling
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Metabolism and nutrition disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Hypoglycaemia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Nervous system disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dizziness
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vascular disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Thrombophlebitis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Treatment Emergent Adverse Device Effect (TEADE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Related to Study Procedure
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Serious TEADE
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Leading to Study Discontinuation
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 3: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening to Day 28To 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: \[Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death\]
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Ecchymosis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Erythema
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Gastrointestinal disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Abdominal pain
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dyspepsia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vomiting
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
General disorders and administration site conditions
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Infusion site hemorrhage
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vessel puncture site swelling
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Subjects with at least one Treatment Emergent Adverse Event (TEAE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Skin and subcutaneous tissue disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Metabolism and nutrition disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Hypoglycaemia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Nervous system disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dizziness
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vascular disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Thrombophlebitis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Treatment Emergent Adverse Device Effect (TEADE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Related to Study Procedure
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Serious TEADE
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Leading to Study Discontinuation
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 4: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening to Day 28To 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: \[Severity Score: 1=Mild; 2=Moderate; 3=Severe; 4=Life-Threatening; 5=Death\]
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Subjects with at least one Treatment Emergent Adverse Event (TEAE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Skin and subcutaneous tissue disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Ecchymosis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Erythema
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Gastrointestinal disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Abdominal pain
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dyspepsia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vomiting
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
General disorders and administration site conditions
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Infusion site hemorrhage
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vessel puncture site swelling
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Metabolism and nutrition disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Hypoglycaemia
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Nervous system disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Dizziness
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Vascular disorders
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Thrombophlebitis
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Treatment Emergent Adverse Device Effect (TEADE)
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Related to Study Procedure
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Serious TEADE
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
TEADE Leading to Study Discontinuation
|
0 Participants
|
|
Incidence of Adverse Device Effects (ADEs) With a Severity Score of 5: Treatment Emergent Adverse Events (TEAEs) by System Organ Class and Preferred Term
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by exploratory markers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Exploratory Biomarkers
Ghrelin
|
1.5 ng/L
Standard Deviation 37.05
|
|
Change From Baseline in Exploratory Biomarkers
Glucagon
|
-13.7 ng/L
Standard Deviation 25.17
|
|
Change From Baseline in Exploratory Biomarkers
Glucagon-Like Peptide-1
|
-26.840 ng/L
Standard Deviation 48.8059
|
|
Change From Baseline in Exploratory Biomarkers
Leptin
|
2770 ng/L
Standard Deviation 6490
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Long-term Glucose Parameters: Fructosamine
|
-17.8 micromol/L
Standard Deviation 18.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by long-term glucose markers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Long-term Glucose Parameters: Hemoglobin A1C
|
-0.11 % A1C
Standard Deviation 0.162
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides
Change from Baseline in Cholesterol
|
-10.9 mg/dL
Standard Deviation 17.00
|
|
Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides
Change from Baseline in HDL Cholesterol
|
-3.9 mg/dL
Standard Deviation 4.90
|
|
Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides
Change from Baseline in LDL Cholesterol
|
-4.9 mg/dL
Standard Deviation 14.80
|
|
Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides
Change from Baseline in VLDL Cholesterol
|
-2.1 mg/dL
Standard Deviation 5.34
|
|
Change From Baseline in Lipid Metabolism Parameters: Cholesterol and Triglycerides
Change from Baseline in Triglycerides
|
-14.3 mg/dL
Standard Deviation 33.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by lipid metabolism markers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Lipid Metabolism Parameters: Free Fatty Acids
|
-0.02 mEq/L
Standard Deviation 0.286
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Inflammatory Biomarkers: Adiponectin
|
-0.70 mg/L
Standard Deviation 0.896
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Inflammatory Biomarkers: C Reactive Protein
|
-0.1 mg/L
Standard Deviation 1.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 18 - Baseline was defined as the last non-missing value collected prior to the first on study hepatic ultrasound insonificationTo evaluate the effect of hepatic ultrasound insonification on glucose metabolism parameters, as assessed by inflammatory biomarkers in blood samples
Outcome measures
| Measure |
Ultrasound Insonification Effect Population
n=16 Participants
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.
|
|---|---|
|
Change From Baseline in Inflammatory Biomarkers: Interleukin-6
|
1.29 ng/L
Standard Deviation 1.445
|
Adverse Events
Safety Population
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Population
n=16 participants at risk
The Safety Population was to consist of all subjects who received at least 1 hepatic ultrasound insonification and included 16 subjects (44.4%).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
2/16 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 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.
|
|
General disorders
Infusion site haemorrhage
|
6.2%
1/16 • Number of events 1 • 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.
|
|
General disorders
Vessel puncture site swelling
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • 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.
|
|
Vascular disorders
Thrombophlebitis
|
6.2%
1/16 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60