Trial Outcomes & Findings for Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients (NCT NCT02151461)

NCT ID: NCT02151461

Last Updated: 2018-02-27

Results Overview

The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs

Results posted on

2018-02-27

Participant Flow

Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of four treatment arms in the ratio of 1:1:1:1 (A:B:C:D). The randomization was stratified by fasting plasma glucose (≥126 mg/dL to \<200 mg/dL, and ≥200 mg/dL to ≤220 mg/dL), as well as metformin experience. Yes/No history of abdominal side effects.

Participant milestones

Participant milestones
Measure	FDC125 Leucine 1100mg +Metformin 125mg	FDC250 Leucine 1100mg +Metformin 250mg	FDC500 Leucine 1100mg +Metformin 500mg	Control Day 1-14: 500mg, Day 15-28: 850mg
Overall Study STARTED	24	25	24	23
Overall Study COMPLETED	18	24	21	19
Overall Study NOT COMPLETED	6	1	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	FDC125 Leucine 1100mg +Metformin 125mg	FDC250 Leucine 1100mg +Metformin 250mg	FDC500 Leucine 1100mg +Metformin 500mg	Control Day 1-14: 500mg, Day 15-28: 850mg
Overall Study Adverse Event	5	1	0	2
Overall Study Lost to Follow-up	0	0	1	1
Overall Study Withdrawal by Subject	1	0	1	1
Overall Study Treatment discontinuation	0	0	1	0

Baseline Characteristics

Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FDC125 n=24 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=25 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=24 Participants Leucine 1100mg +Metformin 500mg	Control n=23 Participants Day 1-14: 500mg, Day 15-28: 850mg	Total n=96 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 9.87 • n=5 Participants	55.1 years STANDARD_DEVIATION 8.3 • n=7 Participants	56.1 years STANDARD_DEVIATION 10.08 • n=5 Participants	59.3 years STANDARD_DEVIATION 9.64 • n=4 Participants	56.0 years STANDARD_DEVIATION 9.56 • n=21 Participants
Age, Customized <65 years	19 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	75 Participants n=21 Participants
Age, Customized ≥65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	51 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	53 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	43 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	16 Participants n=4 Participants	77 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Weight	87.049 kg STANDARD_DEVIATION 17.3747 • n=5 Participants	88.584 kg STANDARD_DEVIATION 19.4687 • n=7 Participants	84.493 kg STANDARD_DEVIATION 19.8622 • n=5 Participants	86.777 kg STANDARD_DEVIATION 16.5700 • n=4 Participants	86.745 kg STANDARD_DEVIATION 18.1696 • n=21 Participants
Body Mass Index (BMI)	31.142 kg/m^2 STANDARD_DEVIATION 4.7113 • n=5 Participants	30.985 kg/m^2 STANDARD_DEVIATION 5.5766 • n=7 Participants	29.927 kg/m^2 STANDARD_DEVIATION 5.1504 • n=5 Participants	31.146 kg/m^2 STANDARD_DEVIATION 4.5838 • n=4 Participants	30.798 kg/m^2 STANDARD_DEVIATION 4.9778 • n=21 Participants
Fasting Plasma Glucose	194.3 mg/dL STANDARD_DEVIATION 50.86 • n=5 Participants	170.3 mg/dL STANDARD_DEVIATION 44.28 • n=7 Participants	182.8 mg/dL STANDARD_DEVIATION 40.97 • n=5 Participants	184.7 mg/dL STANDARD_DEVIATION 50.87 • n=4 Participants	182.9 mg/dL STANDARD_DEVIATION 46.93 • n=21 Participants
Haemoglobin A1c (HbA1c)	7.95 % STANDARD_DEVIATION 0.837 • n=5 Participants	8.01 % STANDARD_DEVIATION 0.713 • n=7 Participants	7.82 % STANDARD_DEVIATION 0.563 • n=5 Participants	8.24 % STANDARD_DEVIATION 0.831 • n=4 Participants	8.00 % STANDARD_DEVIATION 0.747 • n=21 Participants
Previous Metformin experience No Previous Experience	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Previous Metformin experience No Abdominal side effects from prior Metformin	18 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	71 Participants n=21 Participants
Previous Metformin experience Had Abdominal side effects from prior Metformin	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs

Population: Mixed Model Inferential Statistical Analysis of Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)

The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=20 Participants Leucine 1100mg +Metformin 500mg	Control n=18 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr	-18.005 mg*hrs/dL Standard Deviation 142.8374	-45.029 mg*hrs/dL Standard Deviation 114.6701	-64.010 mg*hrs/dL Standard Deviation 146.0917	-141.848 mg*hrs/dL Standard Deviation 194.9300

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Mixed Model Inferential Statistical Analysis of Incremental Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)

The baseline incremental (baseline-subtracted) glucose AUC0-3h was evaluated for treatment differences at baseline.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=20 Participants Leucine 1100mg +Metformin 500mg	Control n=18 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC)	-2.338 mg*hrs/dL Standard Deviation 60.2834	-17.614 mg*hrs/dL Standard Deviation 93.1243	-23.061 mg*hrs/dL Standard Deviation 64.6290	-29.604 mg*hrs/dL Standard Deviation 86.1126

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 28 Evaluable Population (n=73)

Change in fasting plasma glucose for the fixed dose leucine and metformin combination treatments A, B and C was evaluated.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=20 Participants Leucine 1100mg +Metformin 500mg	Control n=18 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change in Fasting Plasma Glucose	-6.8 mg/dL Standard Deviation 36.91	-9.7 mg/dL Standard Deviation 26.50	-13.4 mg/dL Standard Deviation 38.55	-36.0 mg/dL Standard Deviation 47.36

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 28 Evaluable Population (n=73)

Changes in HbA1c which is a marker of long-term glucose control was assessed.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=20 Participants Leucine 1100mg +Metformin 500mg	Control n=18 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change in Hemoglobin A1c (HbA1c)	0.11 percent Standard Deviation 0.448	-0.16 percent Standard Deviation 0.485	-0.01 percent Standard Deviation 0.442	-0.23 percent Standard Deviation 0.607

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Mixed Model Inferential Statistical Analysis of HOMA-IR. Some of the samples collected were not viable and could not be included in the analysis. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.

Effect on insulin sensitivity across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=17 Participants Leucine 1100mg +Metformin 500mg	Control n=16 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)	-0.31 HOMA units Standard Deviation 1.010	-0.14 HOMA units Standard Deviation 0.548	0.11 HOMA units Standard Deviation 0.958	-0.18 HOMA units Standard Deviation 1.017

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 21, Day 28

Population: Mixed Model Inferential Statistical Analysis of 7 point glucose change from day 1-day 28 Evaluable Population (n=73). Some of the samples collected were not viable and could not be included in the analysis. The total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.

The meal induced glucose change in pre-meal and post-meal glucose were measured 7 times during the day. Subjects self-monitored blood glucose (preprandial and postprandial) concentrations at least 7 times, including before and 1 to 2 hours after breakfast, lunch, dinner, and snacks). For each study day, the pre-meal values from the 7 point test for each subject were averaged to generate a single pre-meal glucose value. Similarly, for each study day the post-meal values from the 7-point test for each subject were averaged to generate a single post-meal glucose value. The average change from baseline (i.e., \[(Mean Pre/Post-meal value at Day 28 - Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 21- Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 7- Mean Pre/Post-meal value at Baseline)\]/ 3) over multiple time points listed in Time Frame. The mean pre-meal and post-meal values for baseline, day7, day 21 and day28 were used for comparison.

Outcome measures

Outcome measures
Measure	FDC125 n=16 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=17 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=18 Participants Leucine 1100mg +Metformin 500mg	Control n=15 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change In 7-Point Glucose Profiles 28 day change in Post-meal Glucose Level	-15.98 mg/dL Standard Deviation 33.966	10.56 mg/dL Standard Deviation 44.944	-34.25 mg/dL Standard Deviation 77.268	-50.33 mg/dL Standard Deviation 60.756
Change In 7-Point Glucose Profiles 28 day change in Pre-meal Glucose Level	-6.50 mg/dL Standard Deviation 32.343	-8.96 mg/dL Standard Deviation 61.561	-25.51 mg/dL Standard Deviation 42.198	-53.78 mg/dL Standard Deviation 45.488

SECONDARY outcome

Timeframe: Baseline,Day 28

Population: Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some samples collected were not viable. The total samples collected were still the same but since they couldn't included in the analysis, exact number analyzed is referenced.

Change in meal tolerance test insulin area under the curve (0-2 hr) from Day 1 to Day 28 for fixed-dose leucine and metformin combination treatments.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=19 Participants Leucine 1100mg +Metformin 500mg	Control n=17 Participants Day 1-14: 500mg, Day 15-28: 850mg
Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr Plasma Insulin Absolute	-0.19 h*ulU/ml Standard Deviation 74.531	-5.64 h*ulU/ml Standard Deviation 31.360	-9.59 h*ulU/ml Standard Deviation 34.987	-18.06 h*ulU/ml Standard Deviation 35.473
Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr Plasma Insulin Incremental	4.18 h*ulU/ml Standard Deviation 67.120	-4.25 h*ulU/ml Standard Deviation 29.514	-9.99 h*ulU/ml Standard Deviation 27.956	-15.91 h*ulU/ml Standard Deviation 26.720

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some collected were not viable. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.

Effect on fasting plasma insulin concentrations across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment was evaluated.

Outcome measures

Outcome measures
Measure	FDC125 n=17 Participants Leucine 1100mg +Metformin 125mg	FDC250 n=18 Participants Leucine 1100mg +Metformin 250mg	FDC500 n=19 Participants Leucine 1100mg +Metformin 500mg	Control n=17 Participants Day 1-14: 500mg, Day 15-28: 850mg
Change From Baseline to Day 28 in Fasting Plasma Insulin Concentration	-2.06 h*uIU/mL Standard Deviation 6.652	-0.74 h*uIU/mL Standard Deviation 4.069	0.20 h*uIU/mL Standard Deviation 7.278	-1.03 h*uIU/mL Standard Deviation 7.694

Adverse Events

FDC125

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

FDC250

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

FDC500

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FDC125 n=24 participants at risk Leucine 1100mg +Metformin 125mg	FDC250 n=25 participants at risk Leucine 1100mg +Metformin 250mg	FDC500 n=24 participants at risk Leucine 1100mg +Metformin 500mg	Control n=23 participants at risk Day 1-14: 500mg, Day 15-28: 850mg
Infections and infestations Lacunar Infarction	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	4.0% 1/25 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	4.3% 1/23 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Psychiatric disorders Suicidal Ideation	4.2% 1/24 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.

Other adverse events

Other adverse events
Measure	FDC125 n=24 participants at risk Leucine 1100mg +Metformin 125mg	FDC250 n=25 participants at risk Leucine 1100mg +Metformin 250mg	FDC500 n=24 participants at risk Leucine 1100mg +Metformin 500mg	Control n=23 participants at risk Day 1-14: 500mg, Day 15-28: 850mg
Gastrointestinal disorders Gastric Disorders	12.5% 3/24 • Number of events 3 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	12.0% 3/25 • Number of events 3 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	21.7% 5/23 • Number of events 5 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Infections and infestations Infections	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	4.0% 1/25 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	12.5% 3/24 • Number of events 3 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.7% 2/23 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Metabolism and nutrition disorders Food	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Musculoskeletal and connective tissue disorders Disorders	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	4.0% 1/25 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	12.5% 3/24 • Number of events 3 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.7% 2/23 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Nervous system disorders Nervous Disorders	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.0% 2/25 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Respiratory, thoracic and mediastinal disorders Respiratory Disorders	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	4.0% 1/25 • Number of events 1 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
General disorders Abdominal Distension	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.7% 2/23 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Endocrine disorders Hyperglycemia	8.3% 2/24 • Number of events 2 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/25 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/24 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.	0.00% 0/23 • 30 days Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.

Additional Information

Barbara Cannon

NuSirt Biopharma

Phone: 6156567898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place