Trial Outcomes & Findings for An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients (NCT NCT02435277)

Last Updated: 2018-01-17

Results Overview

Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2018-01-17

Participant Flow

Study NS-0100-01E was a randomized, double-blind 8-week extension of Study NS-0100-01 to evaluate the effect of various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy on glycemic control.

Subjects meeting all inclusion criteria and no exclusion criteria for the NS-001-01-E, including completion of the 4-week treatment period of Study NS-0100-01 (Day 28/Visit 7), were eligible to enroll into the NS-001-01-E.

Participant milestones

Participant milestones
Measure	FDC 125 Leucine 1100mg +Metformin 125mg	FDC 250 Leucine 1100mg +Metformin 250mg	FDC 500 Leucine 1100mg +Metformin 500mg	Control 850mg Metformin
Overall Study STARTED	12	16	11	11
Overall Study COMPLETED	10	15	11	11
Overall Study NOT COMPLETED	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FDC 125 Leucine 1100mg +Metformin 125mg	FDC 250 Leucine 1100mg +Metformin 250mg	FDC 500 Leucine 1100mg +Metformin 500mg	Control 850mg Metformin
Overall Study Adverse Event	1	1	0	0
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FDC 125 n=12 Participants Leucine 1100mg +Metformin 125mg	FDC 250 n=16 Participants Leucine 1100mg +Metformin 250mg	FDC 500 n=11 Participants Leucine 1100mg +Metformin 500mg	Control n=11 Participants 850mg Metformin	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	40 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 10.81 • n=5 Participants	56.1 years STANDARD_DEVIATION 8.24 • n=7 Participants	59.8 years STANDARD_DEVIATION 9.01 • n=5 Participants	60.5 years STANDARD_DEVIATION 8.77 • n=4 Participants	56.9 years STANDARD_DEVIATION 9.52 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	31 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	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 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	2 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	36 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	93.343 kg STANDARD_DEVIATION 19.0179 • n=5 Participants	91.314 kg STANDARD_DEVIATION 18.7664 • n=7 Participants	87.497 kg STANDARD_DEVIATION 21.2259 • n=5 Participants	90.500 kg STANDARD_DEVIATION 18.4163 • n=4 Participants	90.782 kg STANDARD_DEVIATION 18.8230 • n=21 Participants
Body Mass Index (BMI)	33.298 (kg/m^2 STANDARD_DEVIATION 4.4952 • n=5 Participants	31.647 (kg/m^2 STANDARD_DEVIATION 6.3242 • n=7 Participants	28.627 (kg/m^2 STANDARD_DEVIATION 4.5195 • n=5 Participants	32.677 (kg/m^2 STANDARD_DEVIATION 5.3808 • n=4 Participants	31.606 (kg/m^2 STANDARD_DEVIATION 5.4597 • n=21 Participants
Fasting Plasma Glucose	173.5 mg/dL STANDARD_DEVIATION 31.13 • n=5 Participants	150.5 mg/dL STANDARD_DEVIATION 26.78 • n=7 Participants	179.2 mg/dL STANDARD_DEVIATION 36.04 • n=5 Participants	177.1 mg/dL STANDARD_DEVIATION 53.67 • n=4 Participants	168.2 mg/dL STANDARD_DEVIATION 38.00 • n=21 Participants
Haemoglobin A1c (HbA1c)	7.56 % STANDARD_DEVIATION 0.644 • n=5 Participants	7.83 % STANDARD_DEVIATION 0.769 • n=7 Participants	7.84 % STANDARD_DEVIATION 0.545 • n=5 Participants	7.92 % STANDARD_DEVIATION 0.645 • n=4 Participants	7.79 % STANDARD_DEVIATION 0.661 • n=21 Participants
Previous Metformin experience No Previous Experience	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Previous Metformin experience Prior taken metformin: No Abdominal side effects	9 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	35 Participants n=21 Participants
Previous Metformin experience Prior taken metformin: Had abdominal side effects	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)

Outcome measures

Outcome measures
Measure	FDC 125 n=10 Participants Leucine 1100mg +Metformin 125mg	FDC 250 n=12 Participants Leucine 1100mg +Metformin 250mg	FDC 500 n=11 Participants Leucine 1100mg +Metformin 500mg	Control n=10 Participants 850mg Metformin
Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations	0.10 percent HbA1c Standard Deviation 0.756	-0.12 percent HbA1c Standard Deviation 0.987	-0.05 percent HbA1c Standard Deviation 0.807	-0.83 percent HbA1c Standard Deviation 0.627

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)

Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C.

Outcome measures

Outcome measures
Measure	FDC 125 n=10 Participants Leucine 1100mg +Metformin 125mg	FDC 250 n=12 Participants Leucine 1100mg +Metformin 250mg	FDC 500 n=11 Participants Leucine 1100mg +Metformin 500mg	Control n=10 Participants 850mg Metformin
Change in Fasting Plasma Glucose	-15.8 mg/dL Standard Deviation 22.29	11.2 mg/dL Standard Deviation 22.37	-4.3 mg/dL Standard Deviation 39.91	-36.3 mg/dL Standard Deviation 45.47

Adverse Events

FDC 125

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

FDC 250

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

FDC 500

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FDC 125 n=12 participants at risk Leucine 1100mg +Metformin 125mg	FDC 250 n=16 participants at risk Leucine 1100mg +Metformin 250mg	FDC 500 n=11 participants at risk Leucine 1100mg +Metformin 500mg	Control n=11 participants at risk 850mg Metformin
Cardiac disorders Chest Pain	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.

Other adverse events

Other adverse events
Measure	FDC 125 n=12 participants at risk Leucine 1100mg +Metformin 125mg	FDC 250 n=16 participants at risk Leucine 1100mg +Metformin 250mg	FDC 500 n=11 participants at risk Leucine 1100mg +Metformin 500mg	Control n=11 participants at risk 850mg Metformin
Gastrointestinal disorders Gastric Disorders	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	12.5% 2/16 • Number of events 2 • 84 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 84 day study and adverse event reporting was upto day 84.	9.1% 1/11 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Endocrine disorders Endocrine	8.3% 1/12 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Musculoskeletal and connective tissue disorders musculoskeletal	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/16 • 84 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 84 day study and adverse event reporting was upto day 84.	18.2% 2/11 • Number of events 2 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Respiratory, thoracic and mediastinal disorders Respiratory dsorders	16.7% 2/12 • Number of events 2 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
General disorders Cough	16.7% 2/12 • Number of events 2 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/16 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
General disorders Diarrhoea	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	9.1% 1/11 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.
General disorders Ecchymosis	8.3% 1/12 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/16 • 84 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 84 day study and adverse event reporting was upto day 84.	9.1% 1/11 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Endocrine disorders Hyperglycemia	8.3% 1/12 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	12.5% 2/16 • Number of events 2 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
General disorders Fatigue	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
General disorders Chest Pain	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • 84 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 84 day study and adverse event reporting was upto day 84.	6.2% 1/16 • Number of events 1 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.	0.00% 0/11 • 84 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 84 day study and adverse event reporting was upto day 84.

Additional Information

Barbara Cannon

NuSirt Biopharma

Phone: 615-656-7898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place