Trial Outcomes & Findings for Dosing Study of Amino Acids in Seriously Ill Patients (NCT NCT01923480)
NCT ID: NCT01923480
Last Updated: 2017-03-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
One time at pre-clinisol infusion and one time at post-clinisol infusion
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid) Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (AB)
Sequence AB - without Insulin first, then with insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
Sequence BA - with Insulin first, then no insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Period 1 (Hours 1-7)
STARTED
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Period 1 (Hours 1-7)
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Period 1 (Hours 1-7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Hours 1-7)
STARTED
|
1
|
1
|
2
|
2
|
2
|
2
|
|
Period 2 (Hours 1-7)
COMPLETED
|
1
|
1
|
2
|
2
|
2
|
2
|
|
Period 2 (Hours 1-7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosing Study of Amino Acids in Seriously Ill Patients
Baseline characteristics by cohort
| Measure |
15% CLINISOL 0.04 g/kg/hr
n=3 Participants
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr
n=4 Participants
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr
n=4 Participants
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.33 Years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
69.25 Years
STANDARD_DEVIATION 14.93 • n=7 Participants
|
60.50 Years
STANDARD_DEVIATION 6.40 • n=5 Participants
|
63.64 Years
STANDARD_DEVIATION 11.00 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One time at pre-clinisol infusion and one time at post-clinisol infusionPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Change in Net Protein Synthesis
Period 1
|
2.82 g protein/d/kg ffm
Standard Deviation 0
|
3.15 g protein/d/kg ffm
Standard Deviation 0.38
|
4.92 g protein/d/kg ffm
Standard Deviation 0.45
|
11.62 g protein/d/kg ffm
Standard Deviation 6.67
|
6.11 g protein/d/kg ffm
Standard Deviation 2.46
|
9.15 g protein/d/kg ffm
Standard Deviation 2.64
|
|
Change in Net Protein Synthesis
Period 2
|
2.6 g protein/d/kg ffm
Standard Deviation 0
|
2.83 g protein/d/kg ffm
Standard Deviation 0
|
6.13 g protein/d/kg ffm
Standard Deviation 0.62
|
4.89 g protein/d/kg ffm
Standard Deviation 0.81
|
9.10 g protein/d/kg ffm
Standard Deviation 2.52
|
8.29 g protein/d/kg ffm
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Five times during each 7 hour visitPopulation: No data available as no data for this outcome measure were collected during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Nine times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, plasma concentration of glucose was not collected at any time point during Period 1.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=1 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Glucose
Period 2 @ 4hrs
|
103.0 mg/dL
Standard Deviation 0
|
104.0 mg/dL
Standard Deviation 0
|
90.50 mg/dL
Standard Deviation 28.99
|
99.50 mg/dL
Standard Deviation 4.95
|
100.5 mg/dL
Standard Deviation 37.48
|
103.5 mg/dL
Standard Deviation 6.36
|
|
Plasma Concentration of Glucose
Period 2 @ 5.5hrs
|
103.00 mg/dL
Standard Deviation 0
|
104.0 mg/dL
Standard Deviation 0
|
90.50 mg/dL
Standard Deviation 6.36
|
98.00 mg/dL
Standard Deviation 1.41
|
112.5 mg/dL
Standard Deviation 7.78
|
101.5 mg/dL
Standard Deviation 10.61
|
|
Plasma Concentration of Glucose
Period 1 @ 3hrs
|
101.0 mg/dL
Standard Deviation 0
|
92.00 mg/dL
Standard Deviation 0
|
90.00 mg/dL
Standard Deviation 4.24
|
93.50 mg/dL
Standard Deviation 2.12
|
102.0 mg/dL
Standard Deviation 21.21
|
95.00 mg/dL
Standard Deviation 7.07
|
|
Plasma Concentration of Glucose
Period 1 @ 3.5hrs
|
101.0 mg/dL
Standard Deviation 0
|
81.00 mg/dL
Standard Deviation 0
|
93.00 mg/dL
Standard Deviation 5.66
|
94.00 mg/dL
Standard Deviation 8.49
|
104.0 mg/dL
Standard Deviation 19.80
|
111.5 mg/dL
Standard Deviation 7.78
|
|
Plasma Concentration of Glucose
Period 1 @ 4hrs
|
100.0 mg/dL
Standard Deviation 0
|
91.00 mg/dL
Standard Deviation 0
|
94.00 mg/dL
Standard Deviation 5.66
|
97.00 mg/dL
Standard Deviation 1.41
|
103.5 mg/dL
Standard Deviation 13.44
|
110.0 mg/dL
Standard Deviation 15.56
|
|
Plasma Concentration of Glucose
Period 1 @ 4.5hrs
|
93.00 mg/dL
Standard Deviation 0
|
102.0 mg/dL
Standard Deviation 0
|
96.50 mg/dL
Standard Deviation 3.54
|
90.00 mg/dL
Standard Deviation 12.73
|
107.50 mg/dL
Standard Deviation 14.85
|
105.5 mg/dL
Standard Deviation 7.78
|
|
Plasma Concentration of Glucose
Period 1 @ 5hrs
|
95.00 mg/dL
Standard Deviation 0
|
111.0 mg/dL
Standard Deviation 0
|
94.50 mg/dL
Standard Deviation 3.54
|
92.50 mg/dL
Standard Deviation 7.78
|
104.5 mg/dL
Standard Deviation 13.44
|
95.50 mg/dL
Standard Deviation 9.19
|
|
Plasma Concentration of Glucose
Period 1 @ 5.5hrs
|
93.00 mg/dL
Standard Deviation 0
|
89.00 mg/dL
Standard Deviation 0
|
95.00 mg/dL
Standard Deviation 1.41
|
97.00 mg/dL
Standard Deviation 11.31
|
101.0 mg/dL
Standard Deviation 15.56
|
96.50 mg/dL
Standard Deviation 9.19
|
|
Plasma Concentration of Glucose
Period 1 @ 6hrs
|
97.00 mg/dL
Standard Deviation 0
|
75.00 mg/dL
Standard Deviation 0
|
93.00 mg/dL
Standard Deviation 1.41
|
98.00 mg/dL
Standard Deviation 1.41
|
105.5 mg/dL
Standard Deviation 14.85
|
93.50 mg/dL
Standard Deviation 9.19
|
|
Plasma Concentration of Glucose
Period 1 @ 6.5hrs
|
99.00 mg/dL
Standard Deviation 0
|
69.00 mg/dL
Standard Deviation 0
|
93.00 mg/dL
Standard Deviation 1.41
|
92.50 mg/dL
Standard Deviation 3.54
|
100.0 mg/dL
Standard Deviation 11.31
|
95.00 mg/dL
Standard Deviation 7.78
|
|
Plasma Concentration of Glucose
Period 1 @ 7hrs
|
97.00 mg/dL
Standard Deviation 0
|
99.00 mg/dL
Standard Deviation 0
|
91.50 mg/dL
Standard Deviation 2.12
|
86.50 mg/dL
Standard Deviation 0.71
|
101.5 mg/dL
Standard Deviation 14.85
|
93.50 mg/dL
Standard Deviation 2.12
|
|
Plasma Concentration of Glucose
Period 2 @ 3hrs
|
95.00 mg/dL
Standard Deviation 0
|
102.0 mg/dL
Standard Deviation 0
|
88.00 mg/dL
Standard Deviation 2.83
|
96.00 mg/dL
Standard Deviation 4.24
|
102.5 mg/dL
Standard Deviation 20.51
|
94.50 mg/dL
Standard Deviation 9.19
|
|
Plasma Concentration of Glucose
Period 2 @ 3.5hrs
|
103.00 mg/dL
Standard Deviation 0
|
97.00 mg/dL
Standard Deviation 0
|
88.00 mg/dL
Standard Deviation 32.53
|
101.0 mg/dL
Standard Deviation 5.66
|
99.00 mg/dL
Standard Deviation 45.25
|
100.0 mg/dL
Standard Deviation 8.49
|
|
Plasma Concentration of Glucose
Period 2 @ 4.5hrs
|
108.0 mg/dL
Standard Deviation 0
|
103.0 mg/dL
Standard Deviation 0
|
92.00 mg/dL
Standard Deviation 9.90
|
98.00 mg/dL
Standard Deviation 1.41
|
103.0 mg/dL
Standard Deviation 26.87
|
100.0 mg/dL
Standard Deviation 7.07
|
|
Plasma Concentration of Glucose
Period 2 @ 5hrs
|
110.0 mg/dL
Standard Deviation 0
|
103.00 mg/dL
Standard Deviation 0
|
95.00 mg/dL
Standard Deviation 8.49
|
99.00 mg/dL
Standard Deviation 4.24
|
104.5 mg/dL
Standard Deviation 19.09
|
100.0 mg/dL
Standard Deviation 9.90
|
|
Plasma Concentration of Glucose
Period 2 @ 6hrs
|
97.00 mg/dL
Standard Deviation 0
|
106.0 mg/dL
Standard Deviation 0
|
93.00 mg/dL
Standard Deviation 9.90
|
105.0 mg/dL
Standard Deviation 7.07
|
105.0 mg/dL
Standard Deviation 4.24
|
100.0 mg/dL
Standard Deviation 8.49
|
|
Plasma Concentration of Glucose
Period 2 @ 6.5hrs
|
86.00 mg/dL
Standard Deviation 0
|
102.0 mg/dL
Standard Deviation 0
|
84.50 mg/dL
Standard Deviation 4.95
|
103.5 mg/dL
Standard Deviation 6.36
|
101.5 mg/dL
Standard Deviation 9.19
|
98.00 mg/dL
Standard Deviation 8.49
|
|
Plasma Concentration of Glucose
Period 2 @ 7hrs
|
86.00 mg/dL
Standard Deviation 0
|
105.0 mg/dL
Standard Deviation 0
|
75.00 mg/dL
Standard Deviation 2.83
|
100.5 mg/dL
Standard Deviation 0.71
|
107.0 mg/dL
Standard Deviation 1.41
|
98.50 mg/dL
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: Five times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, serum concentration of insulin was not collected at any time point during Period 1. One subject in grp 0.08 g/kg/hr, seq AB, serum concentration of insulin was not collected at the 3hr time point during Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=1 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Insulin
Period 1 @ 3hrs
|
13.70 mciu/mL
Standard Deviation 0
|
4.70 mciu/mL
Standard Deviation 0
|
14.10 mciu/mL
Standard Deviation 13.29
|
9.95 mciu/mL
Standard Deviation 1.20
|
6.90 mciu/mL
Standard Deviation 5.80
|
27.10 mciu/mL
Standard Deviation 19.37
|
|
Serum Concentration of Insulin
Period 1 @ 4hrs
|
23.50 mciu/mL
Standard Deviation 0
|
60.90 mciu/mL
Standard Deviation 0
|
19.10 mciu/mL
Standard Deviation 20.36
|
105.2 mciu/mL
Standard Deviation 0.78
|
12.60 mciu/mL
Standard Deviation 7.50
|
301.9 mciu/mL
Standard Deviation 206.9
|
|
Serum Concentration of Insulin
Period 1 @ 5hrs
|
21.80 mciu/mL
Standard Deviation 0
|
63.40 mciu/mL
Standard Deviation 0
|
21.65 mciu/mL
Standard Deviation 23.41
|
102.0 mciu/mL
Standard Deviation 7.50
|
12.10 mciu/mL
Standard Deviation 4.95
|
259.6 mciu/mL
Standard Deviation 194.3
|
|
Serum Concentration of Insulin
Period 1 @ 6hrs
|
24.40 mciu/mL
Standard Deviation 0
|
70.70 mciu/mL
Standard Deviation 0
|
20.95 mciu/mL
Standard Deviation 20.01
|
100.9 mciu/mL
Standard Deviation 11.17
|
9.05 mciu/mL
Standard Deviation 5.30
|
239.4 mciu/mL
Standard Deviation 192.3
|
|
Serum Concentration of Insulin
Period 1 @ 7hrs
|
20.80 mciu/mL
Standard Deviation 0
|
64.90 mciu/mL
Standard Deviation 0
|
16.60 mciu/mL
Standard Deviation 17.68
|
92.75 mciu/mL
Standard Deviation 26.09
|
9.35 mciu/mL
Standard Deviation 6.58
|
188.5 mciu/mL
Standard Deviation 128.9
|
|
Serum Concentration of Insulin
Period 2 @ 3hrs
|
7.60 mciu/mL
Standard Deviation 0
|
7.80 mciu/mL
Standard Deviation 0
|
2.10 mciu/mL
Standard Deviation 0
|
7.40 mciu/mL
Standard Deviation 0.28
|
8.25 mciu/mL
Standard Deviation 2.05
|
66.20 mciu/mL
Standard Deviation 75.24
|
|
Serum Concentration of Insulin
Period 2 @ 4hrs
|
87.20 mciu/mL
Standard Deviation 0
|
7.20 mciu/mL
Standard Deviation 0
|
66.50 mciu/mL
Standard Deviation 4.95
|
15.30 mciu/mL
Standard Deviation 0.71
|
75.95 mciu/mL
Standard Deviation 23.55
|
139.3 mciu/mL
Standard Deviation 154.1
|
|
Serum Concentration of Insulin
Period 2 @ 5hrs
|
102.4 mciu/mL
Standard Deviation 0
|
5.10 mciu/mL
Standard Deviation 0
|
60.95 mciu/mL
Standard Deviation 1.63
|
12.15 mciu/mL
Standard Deviation 1.77
|
69.85 mciu/mL
Standard Deviation 9.26
|
168.8 mciu/mL
Standard Deviation 206.0
|
|
Serum Concentration of Insulin
Period 2 @ 6hrs
|
73.20 mciu/mL
Standard Deviation 0
|
5.80 mciu/mL
Standard Deviation 0
|
67.20 mciu/mL
Standard Deviation 8.49
|
17.65 mciu/mL
Standard Deviation 9.26
|
73.55 mciu/mL
Standard Deviation 6.15
|
173.0 mciu/mL
Standard Deviation 221.7
|
|
Serum Concentration of Insulin
Period 2 @ 7hrs
|
90.20 mciu/mL
Standard Deviation 0
|
7.90 mciu/mL
Standard Deviation 0
|
67.90 mciu/mL
Standard Deviation 12.16
|
13.15 mciu/mL
Standard Deviation 4.03
|
74.30 mciu/mL
Standard Deviation 15.41
|
143.0 mciu/mL
Standard Deviation 185.5
|
SECONDARY outcome
Timeframe: Twelve times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 2.5hrs
|
0.15 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.05
|
0.08 trace/tracee ratio
Standard Deviation 0.10
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 3hrs
|
0.16 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0.05
|
0.08 trace/tracee ratio
Standard Deviation 0.10
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 3.5hrs
|
0.13 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.05
|
0.10 trace/tracee ratio
Standard Deviation 0.05
|
0.11 trace/tracee ratio
Standard Deviation 0.04
|
0.49 trace/tracee ratio
Standard Deviation 0.56
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 4hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 4.5hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.12 trace/tracee ratio
Standard Deviation 0.03
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 5hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.12 trace/tracee ratio
Standard Deviation 0.03
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 5.5hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.02
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.12 trace/tracee ratio
Standard Deviation 0.03
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 2hrs
|
0.14 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.05
|
0.08 trace/tracee ratio
Standard Deviation 0.09
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 6hrs
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.12 trace/tracee ratio
Standard Deviation 0.03
|
0.10 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 6.5hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.04
|
0.14 trace/tracee ratio
Standard Deviation 0.01
|
0.10 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 1 @ 7hrs
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.01
|
0.13 trace/tracee ratio
Standard Deviation 0.04
|
0.13 trace/tracee ratio
Standard Deviation 0.03
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 2hrs
|
0.16 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.04
|
0.13 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 2.5hrs
|
0.16 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0.04
|
0.14 trace/tracee ratio
Standard Deviation 0.01
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
0.11 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 3hrs
|
0.17 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0.04
|
0.14 trace/tracee ratio
Standard Deviation 0.03
|
0.13 trace/tracee ratio
Standard Deviation 0.01
|
0.12 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 3.5hrs
|
0.14 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.04
|
0.13 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 4hrs
|
0.13 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 4.5hrs
|
0.14 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 5hrs
|
0.15 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 5.5hrs
|
0.14 trace/tracee ratio
Standard Deviation 0
|
0.12 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 6hrs
|
0.15 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 6.5hrs
|
0.15 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.01
|
|
Plasma Stable Isotope Enrichment of Phenylalanine
Period 2 @ 7hrs
|
0.16 trace/tracee ratio
Standard Deviation 0
|
0.11 trace/tracee ratio
Standard Deviation 0
|
0.10 trace/tracee ratio
Standard Deviation 0.03
|
0.12 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Twelve times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 2hrs
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.03 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.07 trace/tracee ratio
Standard Deviation 0.01
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 2.5hrs
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.03 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.07 trace/tracee ratio
Standard Deviation 0.01
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 3hrs
|
0.07 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.07 trace/tracee ratio
Standard Deviation 0.01
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 3.5hrs
|
0.07 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 4hrs
|
0.07 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 4.5hrs
|
0.07 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 5hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 5.5hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.09 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 6hrs
|
0.07 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
0.06 trace/tracee ratio
Standard Deviation 0
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 6.5hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.05
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 1 @ 7hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.10 trace/tracee ratio
Standard Deviation 0.05
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 2hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.04 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.02
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.04 trace/tracee ratio
Standard Deviation 0.01
|
0.07 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 2.5hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.01
|
0.07 trace/tracee ratio
Standard Deviation 0.02
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 3hrs
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.01
|
0.07 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 3.5hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.05 trace/tracee ratio
Standard Deviation 0.01
|
0.07 trace/tracee ratio
Standard Deviation 0.03
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 4hrs
|
0.08 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.05 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 4.5hrs
|
0.88 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 5hrs
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 5.5hrs
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.03
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.09 trace/tracee ratio
Standard Deviation 0.05
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 6hrs
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 6.5hrs
|
0.09 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
|
Plasma Stable Isotope Enrichment of Tyrosine
Period 2 @ 7hrs
|
0.10 trace/tracee ratio
Standard Deviation 0
|
0.05 trace/tracee ratio
Standard Deviation 0
|
0.06 trace/tracee ratio
Standard Deviation 0.02
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
0.06 trace/tracee ratio
Standard Deviation 0.01
|
0.08 trace/tracee ratio
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Alanine
Period 1 @ 3hrs
|
364.9 micromol/L
Standard Deviation 0
|
239.6 micromol/L
Standard Deviation 2.09
|
212.4 micromol/L
Standard Deviation 7.83
|
321.5 micromol/L
Standard Deviation 3.85
|
284.8 micromol/L
Standard Deviation 199.2
|
428.2 micromol/L
Standard Deviation 63.00
|
|
Plasma Concentration of Alanine
Period 1 @ 4.5hrs
|
499.1 micromol/L
Standard Deviation 0
|
292.9 micromol/L
Standard Deviation 36.73
|
347.5 micromol/L
Standard Deviation 3.14
|
648.9 micromol/L
Standard Deviation 73.64
|
468.1 micromol/L
Standard Deviation 195.4
|
840.3 micromol/L
Standard Deviation 304.2
|
|
Plasma Concentration of Alanine
Period 1 @ 7hrs
|
440.0 micromol/L
Standard Deviation 0
|
359.6 micromol/L
Standard Deviation 46.67
|
388.9 micromol/L
Standard Deviation 10.32
|
645.1 micromol/L
Standard Deviation 126.4
|
414.4 micromol/L
Standard Deviation 101.8
|
959.3 micromol/L
Standard Deviation 481.3
|
|
Plasma Concentration of Alanine
Period 2 @ 3hrs
|
340.6 micromol/L
Standard Deviation 0
|
425.8 micromol/L
Standard Deviation 0
|
240.5 micromol/L
Standard Deviation 8.59
|
449.5 micromol/L
Standard Deviation 221.3
|
346.1 micromol/L
Standard Deviation 266.3
|
522.7 micromol/L
Standard Deviation 258.7
|
|
Plasma Concentration of Alanine
Period 2 @ 4.5hrs
|
438.3 micromol/L
Standard Deviation 0
|
407.1 micromol/L
Standard Deviation 0
|
414.4 micromol/L
Standard Deviation 86.71
|
813.7 micromol/L
Standard Deviation 269.6
|
631.5 micromol/L
Standard Deviation 292.7
|
938.9 micromol/L
Standard Deviation 436.0
|
|
Plasma Concentration of Alanine
Period 2 @ 7hrs
|
452.0 micromol/L
Standard Deviation 0
|
463.3 micromol/L
Standard Deviation 0
|
425.8 micromol/L
Standard Deviation 11.01
|
770.3 micromol/L
Standard Deviation 254.9
|
573.0 micromol/L
Standard Deviation 209.0
|
976.6 micromol/L
Standard Deviation 483.5
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Arginine
Period 1 @ 3hrs
|
98.48 micromol/L
Standard Deviation 0
|
69.25 micromol/L
Standard Deviation 11.33
|
71.35 micromol/L
Standard Deviation 17.40
|
61.34 micromol/L
Standard Deviation 2.09
|
82.74 micromol/L
Standard Deviation 39.22
|
88.24 micromol/L
Standard Deviation 5.66
|
|
Plasma Concentration of Arginine
Period 1 @ 4.5hrs
|
153.8 micromol/L
Standard Deviation 0
|
88.42 micromol/L
Standard Deviation 22.85
|
145.8 micromol/L
Standard Deviation 28.74
|
160.1 micromol/L
Standard Deviation 13.87
|
171.9 micromol/L
Standard Deviation 16.72
|
276.6 micromol/L
Standard Deviation 75.96
|
|
Plasma Concentration of Arginine
Period 1 @ 7hrs
|
160.5 micromol/L
Standard Deviation 0
|
94.35 micromol/L
Standard Deviation 3.58
|
159.7 micromol/L
Standard Deviation 27.81
|
173.2 micromol/L
Standard Deviation 2.28
|
167.8 micromol/L
Standard Deviation 6.87
|
307.9 micromol/L
Standard Deviation 108.7
|
|
Plasma Concentration of Arginine
Period 2 @ 3hrs
|
84.17 micromol/L
Standard Deviation 0
|
81.10 micromol/L
Standard Deviation 0
|
85.71 micromol/L
Standard Deviation 30.99
|
72.54 micromol/L
Standard Deviation 7.09
|
79.34 micromol/L
Standard Deviation 29.04
|
100.7 micromol/L
Standard Deviation 22.21
|
|
Plasma Concentration of Arginine
Period 2 @ 4.5hrs
|
120.4 micromol/L
Standard Deviation 0
|
115.7 micromol/L
Standard Deviation 0
|
151.6 micromol/L
Standard Deviation 34.59
|
195.6 micromol/L
Standard Deviation 9.68
|
204.1 micromol/L
Standard Deviation 99.12
|
284.2 micromol/L
Standard Deviation 86.42
|
|
Plasma Concentration of Arginine
Period 2 @ 7hrs
|
130.3 micromol/L
Standard Deviation 0
|
139.0 micromol/L
Standard Deviation 0
|
152.7 micromol/L
Standard Deviation 9.45
|
221.9 micromol/L
Standard Deviation 36.78
|
200.9 micromol/L
Standard Deviation 102.1
|
294.3 micromol/L
Standard Deviation 86.06
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Aspartic Acid
Period 1 @ 3hrs
|
3.98 micromol/L
Standard Deviation 0
|
1.95 micromol/L
Standard Deviation 0.39
|
2.18 micromol/L
Standard Deviation 0.61
|
2.53 micromol/L
Standard Deviation 0.12
|
2.88 micromol/L
Standard Deviation 0.17
|
3.27 micromol/L
Standard Deviation 0.66
|
|
Plasma Concentration of Aspartic Acid
Period 1 @ 4.5hrs
|
10.47 micromol/L
Standard Deviation 0
|
4.13 micromol/L
Standard Deviation 2.79
|
9.52 micromol/L
Standard Deviation 2.68
|
9.60 micromol/L
Standard Deviation 0.67
|
12.56 micromol/L
Standard Deviation 1.12
|
23.45 micromol/L
Standard Deviation 1.58
|
|
Plasma Concentration of Aspartic Acid
Period 1 @ 7hrs
|
10.95 micromol/L
Standard Deviation 0
|
2.43 micromol/L
Standard Deviation 0.59
|
9.24 micromol/L
Standard Deviation 0.57
|
9.04 micromol/L
Standard Deviation 3.01
|
9.73 micromol/L
Standard Deviation 0.98
|
31.28 micromol/L
Standard Deviation 11.53
|
|
Plasma Concentration of Aspartic Acid
Period 2 @ 3hrs
|
2.87 micromol/L
Standard Deviation 0
|
2.52 micromol/L
Standard Deviation 0
|
2.40 micromol/L
Standard Deviation 1.03
|
2.92 micromol/L
Standard Deviation 0.55
|
3.71 micromol/L
Standard Deviation 1.35
|
3.76 micromol/L
Standard Deviation 1.28
|
|
Plasma Concentration of Aspartic Acid
Period 2 @ 4.5hrs
|
7.57 micromol/L
Standard Deviation 0
|
4.21 micromol/L
Standard Deviation 0
|
6.55 micromol/L
Standard Deviation 1.89
|
11.67 micromol/L
Standard Deviation 0.36
|
15.38 micromol/L
Standard Deviation 4.19
|
22.67 micromol/L
Standard Deviation 0.95
|
|
Plasma Concentration of Aspartic Acid
Period 2 @ 7hrs
|
7.99 micromol/L
Standard Deviation 0
|
4.07 micromol/L
Standard Deviation 0
|
8.98 micromol/L
Standard Deviation 8.13
|
11.11 micromol/L
Standard Deviation 1.20
|
15.43 micromol/L
Standard Deviation 2.30
|
21.79 micromol/L
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Glutamic Acid
Period 1 @ 3hrs
|
586.0 micromol/L
Standard Deviation 0
|
659.1 micromol/L
Standard Deviation 120.1
|
561.1 micromol/L
Standard Deviation 108.5
|
678.3 micromol/L
Standard Deviation 28.45
|
588.4 micromol/L
Standard Deviation 172.6
|
644.8 micromol/L
Standard Deviation 27.42
|
|
Plasma Concentration of Glutamic Acid
Period 1 @ 4.5hrs
|
634.8 micromol/L
Standard Deviation 0
|
599.5 micromol/L
Standard Deviation 167.4
|
561.9 micromol/L
Standard Deviation 179.0
|
647.9 micromol/L
Standard Deviation 48.97
|
646.6 micromol/L
Standard Deviation 158.3
|
690.9 micromol/L
Standard Deviation 100.7
|
|
Plasma Concentration of Glutamic Acid
Period 1 @ 7hrs
|
647.8 micromol/L
Standard Deviation 0
|
661.2 micromol/L
Standard Deviation 93.35
|
573.7 micromol/L
Standard Deviation 131.0
|
560.1 micromol/L
Standard Deviation 99.21
|
576.0 micromol/L
Standard Deviation 98.2
|
710.8 micromol/L
Standard Deviation 211.5
|
|
Plasma Concentration of Glutamic Acid
Period 2 @ 3hrs
|
587.3 micromol/L
Standard Deviation 0
|
884.3 micromol/L
Standard Deviation 0
|
588.9 micromol/L
Standard Deviation 138.8
|
722.5 micromol/L
Standard Deviation 125.8
|
607.5 micromol/L
Standard Deviation 119.3
|
727.1 micromol/L
Standard Deviation 153.3
|
|
Plasma Concentration of Glutamic Acid
Period 2 @ 4.5hrs
|
510.8 micromol/L
Standard Deviation 0
|
926.7 micromol/L
Standard Deviation 0
|
563.5 micromol/L
Standard Deviation 150.4
|
811.7 micromol/L
Standard Deviation 159.9
|
606.9 micromol/L
Standard Deviation 111.6
|
809.3 micromol/L
Standard Deviation 180.6
|
|
Plasma Concentration of Glutamic Acid
Period 2 @ 7hrs
|
489.2 micromol/L
Standard Deviation 0
|
854.5 micromol/L
Standard Deviation 0
|
510.0 micromol/L
Standard Deviation 123.1
|
735.0 micromol/L
Standard Deviation 215.9
|
531.4 micromol/L
Standard Deviation 72.39
|
808.6 micromol/L
Standard Deviation 237.8
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Glutamine
Period 2 @ 4.5hrs
|
72.71 micromol/L
Standard Deviation 0
|
20.70 micromol/L
Standard Deviation 0
|
51.03 micromol/L
Standard Deviation 22.43
|
84.88 micromol/L
Standard Deviation 7.67
|
106.0 micromol/L
Standard Deviation 44.36
|
137.0 micromol/L
Standard Deviation 15.99
|
|
Plasma Concentration of Glutamine
Period 1 @ 3hrs
|
75.20 micromol/L
Standard Deviation 0
|
25.55 micromol/L
Standard Deviation 11.72
|
43.94 micromol/L
Standard Deviation 15.40
|
46.75 micromol/L
Standard Deviation 0.04
|
60.22 micromol/L
Standard Deviation 29.73
|
69.89 micromol/L
Standard Deviation 18.67
|
|
Plasma Concentration of Glutamine
Period 1 @ 4.5hrs
|
99.73 micromol/L
Standard Deviation 0
|
25.08 micromol/L
Standard Deviation 1.92
|
70.98 micromol/L
Standard Deviation 27.55
|
65.68 micromol/L
Standard Deviation 2.20
|
105.1 micromol/L
Standard Deviation 38.45
|
142.3 micromol/L
Standard Deviation 18.79
|
|
Plasma Concentration of Glutamine
Period 1 @ 7hrs
|
100.0 micromol/L
Standard Deviation 0
|
18.58 micromol/L
Standard Deviation 5.77
|
68.48 micromol/L
Standard Deviation 14.21
|
60.20 micromol/L
Standard Deviation 17.41
|
92.00 micromol/L
Standard Deviation 25.10
|
175.10 micromol/L
Standard Deviation 30.72
|
|
Plasma Concentration of Glutamine
Period 2 @ 3hrs
|
71.27 micromol/L
Standard Deviation 0
|
17.48 micromol/L
Standard Deviation 0
|
40.23 micromol/L
Standard Deviation 14.76
|
57.03 micromol/L
Standard Deviation 18.79
|
67.96 micromol/L
Standard Deviation 21.47
|
68.15 micromol/L
Standard Deviation 19.74
|
|
Plasma Concentration of Glutamine
Period 2 @ 7hrs
|
71.57 micromol/L
Standard Deviation 0
|
24.35 micromol/L
Standard Deviation 0
|
54.79 micromol/L
Standard Deviation 49.63
|
85.71 micromol/L
Standard Deviation 16.02
|
103.5 micromol/L
Standard Deviation 35.21
|
131.1 micromol/L
Standard Deviation 13.87
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Glycine
Period 1 @ 3hrs
|
217.2 micromol/L
Standard Deviation 0
|
282.2 micromol/L
Standard Deviation 68.99
|
164.4 micromol/L
Standard Deviation 0.97
|
188.9 micromol/L
Standard Deviation 20.63
|
153.2 micromol/L
Standard Deviation 23.80
|
183.2 micromol/L
Standard Deviation 16.61
|
|
Plasma Concentration of Glycine
Period 1 @ 4.5hrs
|
304.6 micromol/L
Standard Deviation 0
|
316.8 micromol/L
Standard Deviation 113.2
|
243.6 micromol/L
Standard Deviation 9.33
|
332.3 micromol/L
Standard Deviation 37.75
|
254.0 micromol/L
Standard Deviation 8.27
|
417.6 micromol/L
Standard Deviation 142.8
|
|
Plasma Concentration of Glycine
Period 1 @ 7hrs
|
307.1 micromol/L
Standard Deviation 0
|
388.4 micromol/L
Standard Deviation 63.14
|
248.7 micromol/L
Standard Deviation 8.33
|
331.70 micromol/L
Standard Deviation 32.97
|
234.5 micromol/L
Standard Deviation 13.48
|
477.0 micromol/L
Standard Deviation 214.5
|
|
Plasma Concentration of Glycine
Period 2 @ 3hrs
|
215.9 micromol/L
Standard Deviation 0
|
316.3 micromol/L
Standard Deviation 0
|
196.7 micromol/L
Standard Deviation 33.50
|
210.1 micromol/L
Standard Deviation 45.73
|
162.3 micromol/L
Standard Deviation 17.64
|
223.8 micromol/L
Standard Deviation 73.09
|
|
Plasma Concentration of Glycine
Period 2 @ 4.5hrs
|
252.0 micromol/L
Standard Deviation 0
|
372.3 micromol/L
Standard Deviation 0
|
272.2 micromol/L
Standard Deviation 50.56
|
394.9 micromol/L
Standard Deviation 73.01
|
318.1 micromol/L
Standard Deviation 94.07
|
473.2 micromol/L
Standard Deviation 194.6
|
|
Plasma Concentration of Glycine
Period 2 @ 7hrs
|
278.3 micromol/L
Standard Deviation 0
|
409.9 micromol/L
Standard Deviation 0
|
272.9 micromol/L
Standard Deviation 21.39
|
383.2 micromol/L
Standard Deviation 77.85
|
315.0 micromol/L
Standard Deviation 48.70
|
481.5 micromol/L
Standard Deviation 207.0
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Histidine
Period 1 @ 3hrs
|
59.79 micromol/L
Standard Deviation 0
|
68.48 micromol/L
Standard Deviation 23.33
|
53.21 micromol/L
Standard Deviation 3.43
|
64.81 micromol/L
Standard Deviation 11.94
|
60.28 micromol/L
Standard Deviation 17.90
|
67.55 micromol/L
Standard Deviation 6.56
|
|
Plasma Concentration of Histidine
Period 1 @ 4.5hrs
|
102.0 micromol/L
Standard Deviation 0
|
85.49 micromol/L
Standard Deviation 35.85
|
92.18 micromol/L
Standard Deviation 6.92
|
127.80 micromol/L
Standard Deviation 0.95
|
110.7 micromol/L
Standard Deviation 11.70
|
189.8 micromol/L
Standard Deviation 65.20
|
|
Plasma Concentration of Histidine
Period 1 @ 7hrs
|
105.1 micromol/L
Standard Deviation 0
|
101.5 micromol/L
Standard Deviation 27.27
|
102.0 micromol/L
Standard Deviation 5.50
|
134.2 micromol/L
Standard Deviation 5.65
|
109.5 micromol/L
Standard Deviation 0.79
|
257.0 micromol/L
Standard Deviation 157.5
|
|
Plasma Concentration of Histidine
Period 2 @ 3hrs
|
57.64 micromol/L
Standard Deviation 0
|
82.09 micromol/L
Standard Deviation 0
|
49.86 micromol/L
Standard Deviation 8.74
|
68.17 micromol/L
Standard Deviation 14.31
|
64.02 micromol/L
Standard Deviation 3.67
|
73.54 micromol/L
Standard Deviation 3.86
|
|
Plasma Concentration of Histidine
Period 2 @ 4.5hrs
|
78.64 micromol/L
Standard Deviation 0
|
107.6 micromol/L
Standard Deviation 0
|
88.02 micromol/L
Standard Deviation 1.17
|
147.5 micromol/L
Standard Deviation 12.87
|
131.1 micromol/L
Standard Deviation 30.02
|
186.4 micromol/L
Standard Deviation 57.07
|
|
Plasma Concentration of Histidine
Period 2 @ 7hrs
|
92.85 micromol/L
Standard Deviation 0
|
122.2 micromol/L
Standard Deviation 0
|
96.02 micromol/L
Standard Deviation 6.94
|
166.2 micromol/L
Standard Deviation 6.55
|
130.3 micromol/L
Standard Deviation 15.85
|
217.7 micromol/L
Standard Deviation 99.88
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Isoleucine
Period 1 @ 3hrs
|
78.62 micromol/L
Standard Deviation 0
|
44.71 micromol/L
Standard Deviation 1.33
|
51.67 micromol/L
Standard Deviation 9.86
|
62.79 micromol/L
Standard Deviation 4.14
|
58.87 micromol/L
Standard Deviation 22.53
|
73.22 micromol/L
Standard Deviation 0.92
|
|
Plasma Concentration of Isoleucine
Period 1 @ 4.5hrs
|
113.6 micromol/L
Standard Deviation 0
|
46.11 micromol/L
Standard Deviation 2.99
|
106.6 micromol/L
Standard Deviation 12.32
|
111.2 micromol/L
Standard Deviation 2.28
|
112.1 micromol/L
Standard Deviation 8.92
|
192.9 micromol/L
Standard Deviation 68.37
|
|
Plasma Concentration of Isoleucine
Period 1 @ 7hrs
|
122.3 micromol/L
Standard Deviation 0
|
47.07 micromol/L
Standard Deviation 0.78
|
141.5 micromol/L
Standard Deviation 25.44
|
116.3 micromol/L
Standard Deviation 4.68
|
138.3 micromol/L
Standard Deviation 8.17
|
247.5 micromol/L
Standard Deviation 122.0
|
|
Plasma Concentration of Isoleucine
Period 2 @ 3hrs
|
61.12 micromol/L
Standard Deviation 0
|
44.49 micromol/L
Standard Deviation 0
|
77.59 micromol/L
Standard Deviation 36.35
|
64.74 micromol/L
Standard Deviation 15.58
|
53.35 micromol/L
Standard Deviation 30.00
|
76.08 micromol/L
Standard Deviation 8.34
|
|
Plasma Concentration of Isoleucine
Period 2 @ 4.5hrs
|
76.59 micromol/L
Standard Deviation 0
|
69.09 micromol/L
Standard Deviation 0
|
105.8 micromol/L
Standard Deviation 47.35
|
142.9 micromol/L
Standard Deviation 17.86
|
127.7 micromol/L
Standard Deviation 77.87
|
193.5 micromol/L
Standard Deviation 38.50
|
|
Plasma Concentration of Isoleucine
Period 2 @ 7hrs
|
77.31 micromol/L
Standard Deviation 0
|
89.49 micromol/L
Standard Deviation 0
|
108.9 micromol/L
Standard Deviation 72.63
|
181.3 micromol/L
Standard Deviation 12.57
|
137.3 micromol/L
Standard Deviation 99.68
|
228.1 micromol/L
Standard Deviation 64.48
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Leucine
Period 1 @ 3hrs
|
105.0 micromol/L
Standard Deviation 0
|
88.40 micromol/L
Standard Deviation 1.63
|
88.55 micromol/L
Standard Deviation 20.92
|
83.72 micromol/L
Standard Deviation 8.61
|
90.14 micromol/L
Standard Deviation 30.71
|
124.3 micromol/L
Standard Deviation 1.61
|
|
Plasma Concentration of Leucine
Period 1 @ 4.5hrs
|
144.8 micromol/L
Standard Deviation 0
|
76.54 micromol/L
Standard Deviation 0.83
|
156.9 micromol/L
Standard Deviation 27.03
|
137.8 micromol/L
Standard Deviation 0.51
|
157.2 micromol/L
Standard Deviation 16.09
|
270.9 micromol/L
Standard Deviation 88.68
|
|
Plasma Concentration of Leucine
Period 1 @ 7hrs
|
150.00 micromol/L
Standard Deviation 0
|
71.11 micromol/L
Standard Deviation 5.83
|
199.3 micromol/L
Standard Deviation 42.32
|
134.0 micromol/L
Standard Deviation 18.30
|
180.0 micromol/L
Standard Deviation 10.33
|
344.6 micromol/L
Standard Deviation 173.9
|
|
Plasma Concentration of Leucine
Period 2 @ 3hrs
|
85.48 micromol/L
Standard Deviation 0
|
77.60 micromol/L
Standard Deviation 0
|
105.3 micromol/L
Standard Deviation 64.54
|
84.90 micromol/L
Standard Deviation 22.05
|
92.46 micromol/L
Standard Deviation 12.77
|
131.0 micromol/L
Standard Deviation 8.08
|
|
Plasma Concentration of Leucine
Period 2 @ 4.5hrs
|
98.69 micromol/L
Standard Deviation 0
|
112.3 micromol/L
Standard Deviation 0
|
130.9 micromol/L
Standard Deviation 74.81
|
179.5 micromol/L
Standard Deviation 30.22
|
173.9 micromol/L
Standard Deviation 83.38
|
277.6 micromol/L
Standard Deviation 71.59
|
|
Plasma Concentration of Leucine
Period 2 @ 7hrs
|
94.28 micromol/L
Standard Deviation 0
|
135.4 micromol/L
Standard Deviation 0
|
124.4 micromol/L
Standard Deviation 93.67
|
218.6 micromol/L
Standard Deviation 9.36
|
186.9 micromol/L
Standard Deviation 114.5
|
326.3 micromol/L
Standard Deviation 101.7
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Lysine
Period 1 @ 3hrs
|
169.4 micromol/L
Standard Deviation 0
|
153.5 micromol/L
Standard Deviation 23.62
|
137.8 micromol/L
Standard Deviation 9.50
|
152.2 micromol/L
Standard Deviation 1.90
|
150.8 micromol/L
Standard Deviation 49.38
|
205.8 micromol/L
Standard Deviation 37.52
|
|
Plasma Concentration of Lysine
Period 1 @ 4.5hrs
|
213.8 micromol/L
Standard Deviation 0
|
167.4 micromol/L
Standard Deviation 6.38
|
208.7 micromol/L
Standard Deviation 11.18
|
254.1 micromol/L
Standard Deviation 18.31
|
246.0 micromol/L
Standard Deviation 25.41
|
396.5 micromol/L
Standard Deviation 50.69
|
|
Plasma Concentration of Lysine
Period 1 @ 7hrs
|
212.2 micromol/L
Standard Deviation 0
|
183.2 micromol/L
Standard Deviation 41.15
|
224.0 micromol/L
Standard Deviation 11.58
|
252.1 micromol/L
Standard Deviation 25.75
|
235.10 micromol/L
Standard Deviation 16.79
|
461.7 micromol/L
Standard Deviation 109.8
|
|
Plasma Concentration of Lysine
Period 2 @ 3hrs
|
160.6 micromol/L
Standard Deviation 0
|
132.0 micromol/L
Standard Deviation 0
|
140.6 micromol/L
Standard Deviation 17.39
|
154.6 micromol/L
Standard Deviation 9.27
|
157.6 micromol/L
Standard Deviation 29.60
|
234.4 micromol/L
Standard Deviation 3.42
|
|
Plasma Concentration of Lysine
Period 2 @ 4.5hrs
|
189.7 micromol/L
Standard Deviation 0
|
172.5 micromol/L
Standard Deviation 0
|
203.2 micromol/L
Standard Deviation 15.35
|
289.3 micromol/L
Standard Deviation 15.13
|
279.6 micromol/L
Standard Deviation 95.81
|
429.3 micromol/L
Standard Deviation 69.88
|
|
Plasma Concentration of Lysine
Period 2 @ 7hrs
|
205.3 micromol/L
Standard Deviation 0
|
206.8 micromol/L
Standard Deviation 0
|
209.7 micromol/L
Standard Deviation 45.73
|
303.8 micromol/L
Standard Deviation 49.51
|
278.3 micromol/L
Standard Deviation 105.0
|
437.7 micromol/L
Standard Deviation 56.65
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Methionine
Period 1 @ 3hrs
|
22.79 micromol/L
Standard Deviation 0
|
20.33 micromol/L
Standard Deviation 2.29
|
17.88 micromol/L
Standard Deviation 1.83
|
21.20 micromol/L
Standard Deviation 0.23
|
15.96 micromol/L
Standard Deviation 4.54
|
23.39 micromol/L
Standard Deviation 0.55
|
|
Plasma Concentration of Methionine
Period 1 @ 4.5hrs
|
53.19 micromol/L
Standard Deviation 0
|
35.06 micromol/L
Standard Deviation 3.34
|
56.60 micromol/L
Standard Deviation 2.19
|
77.47 micromol/L
Standard Deviation 9.77
|
58.39 micromol/L
Standard Deviation 5.08
|
132.5 micromol/L
Standard Deviation 57.06
|
|
Plasma Concentration of Methionine
Period 1 @ 7hrs
|
61.44 micromol/L
Standard Deviation 0
|
48.44 micromol/L
Standard Deviation 3.80
|
69.93 micromol/L
Standard Deviation 1.00
|
99.33 micromol/L
Standard Deviation 7.30
|
64.98 micromol/L
Standard Deviation 12.04
|
218.50 micromol/L
Standard Deviation 140.3
|
|
Plasma Concentration of Methionine
Period 2 @ 3hrs
|
19.18 micromol/L
Standard Deviation 0
|
28.76 micromol/L
Standard Deviation 0
|
18.35 micromol/L
Standard Deviation 1.83
|
20.07 micromol/L
Standard Deviation 0.15
|
15.98 micromol/L
Standard Deviation 4.09
|
26.73 micromol/L
Standard Deviation 6.80
|
|
Plasma Concentration of Methionine
Period 2 @ 4.5hrs
|
43.63 micromol/L
Standard Deviation 0
|
47.99 micromol/L
Standard Deviation 0
|
54.89 micromol/L
Standard Deviation 1.38
|
86.24 micromol/L
Standard Deviation 3.05
|
82.96 micromol/L
Standard Deviation 31.71
|
127.9 micromol/L
Standard Deviation 52.59
|
|
Plasma Concentration of Methionine
Period 2 @ 7hrs
|
53.57 micromol/L
Standard Deviation 0
|
62.97 micromol/L
Standard Deviation 0
|
69.01 micromol/L
Standard Deviation 9.43
|
177.2 micromol/L
Standard Deviation 18.41
|
103.8 micromol/L
Standard Deviation 45.25
|
186.6 micromol/L
Standard Deviation 100.9
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Ornithine
Period 1 @ 3hrs
|
65.99 micromol/L
Standard Deviation 0
|
56.25 micromol/L
Standard Deviation 6.89
|
48.50 micromol/L
Standard Deviation 6.93
|
36.15 micromol/L
Standard Deviation 2.64
|
62.47 micromol/L
Standard Deviation 1.51
|
72.31 micromol/L
Standard Deviation 0.38
|
|
Plasma Concentration of Ornithine
Period 1 @ 4.5hrs
|
76.46 micromol/L
Standard Deviation 0
|
53.26 micromol/L
Standard Deviation 6.92
|
74.83 micromol/L
Standard Deviation 6.75
|
52.15 micromol/L
Standard Deviation 2.32
|
94.60 micromol/L
Standard Deviation 18.24
|
117.0 micromol/L
Standard Deviation 22.25
|
|
Plasma Concentration of Ornithine
Period 1 @ 7hrs
|
73.94 micromol/L
Standard Deviation 0
|
60.75 micromol/L
Standard Deviation 10.88
|
111.3 micromol/L
Standard Deviation 7.29
|
70.69 micromol/L
Standard Deviation 2.96
|
111.1 micromol/L
Standard Deviation 22.55
|
183.1 micromol/L
Standard Deviation 70.92
|
|
Plasma Concentration of Ornithine
Period 2 @ 3hrs
|
44.10 micromol/L
Standard Deviation 0
|
53.40 micromol/L
Standard Deviation 0
|
55.20 micromol/L
Standard Deviation 0.77
|
45.40 micromol/L
Standard Deviation 2.81
|
66.82 micromol/L
Standard Deviation 11.00
|
71.57 micromol/L
Standard Deviation 14.10
|
|
Plasma Concentration of Ornithine
Period 2 @ 4.5hrs
|
47.40 micromol/L
Standard Deviation 0
|
63.29 micromol/L
Standard Deviation 0
|
68.22 micromol/L
Standard Deviation 13.24
|
69.56 micromol/L
Standard Deviation 5.56
|
91.27 micromol/L
Standard Deviation 0.83
|
104.6 micromol/L
Standard Deviation 15.46
|
|
Plasma Concentration of Ornithine
Period 2 @ 7hrs
|
53.58 micromol/L
Standard Deviation 0
|
80.14 micromol/L
Standard Deviation 0
|
81.59 micromol/L
Standard Deviation 36.61
|
97.83 micromol/L
Standard Deviation 16.31
|
113.3 micromol/L
Standard Deviation 29.62
|
145.1 micromol/L
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Phenylalanine
Period 2 @ 7hrs
|
107.3 micromol/L
Standard Deviation 0
|
99.77 micromol/L
Standard Deviation 0
|
128.3 micromol/L
Standard Deviation 18.08
|
248.7 micromol/L
Standard Deviation 120.2
|
160.5 micromol/L
Standard Deviation 47.84
|
253.0 micromol/L
Standard Deviation 94.40
|
|
Plasma Concentration of Phenylalanine
Period 1 @ 4.5hrs
|
105.8 micromol/L
Standard Deviation 0
|
79.75 micromol/L
Standard Deviation 0.39
|
117.4 micromol/L
Standard Deviation 5.35
|
164.8 micromol/L
Standard Deviation 64.84
|
113.5 micromol/L
Standard Deviation 3.73
|
205.6 micromol/L
Standard Deviation 71.52
|
|
Plasma Concentration of Phenylalanine
Period 1 @ 7hrs
|
119.6 micromol/L
Standard Deviation 0
|
106.2 micromol/L
Standard Deviation 22.37
|
147.3 micromol/L
Standard Deviation 4.97
|
220.4 micromol/L
Standard Deviation 103.1
|
122.6 micromol/L
Standard Deviation 13.89
|
303.6 micromol/L
Standard Deviation 158.2
|
|
Plasma Concentration of Phenylalanine
Period 2 @ 3hrs
|
59.96 micromol/L
Standard Deviation 0
|
65.00 micromol/L
Standard Deviation 0
|
56.40 micromol/L
Standard Deviation 2.80
|
83.63 micromol/L
Standard Deviation 49.38
|
56.96 micromol/L
Standard Deviation 2.38
|
71.17 micromol/L
Standard Deviation 10.26
|
|
Plasma Concentration of Phenylalanine
Period 2 @ 4.5hrs
|
91.84 micromol/L
Standard Deviation 0
|
86.46 micromol/L
Standard Deviation 0
|
106.5 micromol/L
Standard Deviation 1.20
|
182.4 micromol/L
Standard Deviation 80.49
|
137.90 micromol/L
Standard Deviation 33.42
|
191.7 micromol/L
Standard Deviation 56.38
|
|
Plasma Concentration of Phenylalanine
Period 1 @ 3hrs
|
64.83 micromol/L
Standard Deviation 0
|
62.14 micromol/L
Standard Deviation 9.96
|
63.96 micromol/L
Standard Deviation 1.48
|
77.74 micromol/L
Standard Deviation 53.20
|
58.07 micromol/L
Standard Deviation 8.79
|
70.80 micromol/L
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Proline
Period 1 @ 3hrs
|
231.3 micromol/L
Standard Deviation 0
|
131.9 micromol/L
Standard Deviation 39.20
|
126.4 micromol/L
Standard Deviation 31.64
|
182.8 micromol/L
Standard Deviation 49.00
|
177.0 micromol/L
Standard Deviation 73.16
|
216.5 micromol/L
Standard Deviation 45.65
|
|
Plasma Concentration of Proline
Period 1 @ 4.5hrs
|
270.9 micromol/L
Standard Deviation 0
|
135.5 micromol/L
Standard Deviation 36.88
|
201.6 micromol/L
Standard Deviation 40.98
|
285.5 micromol/L
Standard Deviation 25.26
|
275.2 micromol/L
Standard Deviation 43.89
|
412.0 micromol/L
Standard Deviation 57.04
|
|
Plasma Concentration of Proline
Period 1 @ 7hrs
|
268.5 micromol/L
Standard Deviation 0
|
146.0 micromol/L
Standard Deviation 21.91
|
243.8 micromol/L
Standard Deviation 54.40
|
297.8 micromol/L
Standard Deviation 33.74
|
284.3 micromol/L
Standard Deviation 24.20
|
501.8 micromol/L
Standard Deviation 151.6
|
|
Plasma Concentration of Proline
Period 2 @ 3hrs
|
161.6 micromol/L
Standard Deviation 0
|
212.5 micromol/L
Standard Deviation 0
|
135.5 micromol/L
Standard Deviation 21.04
|
230.9 micromol/L
Standard Deviation 9.20
|
183.2 micromol/L
Standard Deviation 76.25
|
256.3 micromol/L
Standard Deviation 34.95
|
|
Plasma Concentration of Proline
Period 2 @ 4.5hrs
|
186.2 micromol/L
Standard Deviation 0
|
264.5 micromol/L
Standard Deviation 0
|
202.0 micromol/L
Standard Deviation 46.23
|
372.2 micromol/L
Standard Deviation 13.29
|
315.6 micromol/L
Standard Deviation 131.3
|
454.2 micromol/L
Standard Deviation 113.5
|
|
Plasma Concentration of Proline
Period 2 @ 7hrs
|
206.5 micromol/L
Standard Deviation 0
|
271.4 micromol/L
Standard Deviation 0
|
228.2 micromol/L
Standard Deviation 97.49
|
399.0 micromol/L
Standard Deviation 23.65
|
331.3 micromol/L
Standard Deviation 158.1
|
506.5 micromol/L
Standard Deviation 150.2
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Serine
Period 1 @ 3hrs
|
112.70 micromol/L
Standard Deviation 0
|
92.46 micromol/L
Standard Deviation 0.25
|
77.91 micromol/L
Standard Deviation 8.55
|
97.72 micromol/L
Standard Deviation 6.94
|
76.12 micromol/L
Standard Deviation 6.26
|
76.13 micromol/L
Standard Deviation 10.25
|
|
Plasma Concentration of Serine
Period 1 @ 4.5hrs
|
142.0 micromol/L
Standard Deviation 0
|
92.09 micromol/L
Standard Deviation 14.88
|
112.0 micromol/L
Standard Deviation 3.11
|
144.0 micromol/L
Standard Deviation 15.52
|
130.2 micromol/L
Standard Deviation 24.73
|
162.6 micromol/L
Standard Deviation 37.36
|
|
Plasma Concentration of Serine
Period 1 @ 7hrs
|
148.7 micromol/L
Standard Deviation 0
|
107.9 micromol/L
Standard Deviation 3.32
|
121.9 micromol/L
Standard Deviation 7.28
|
139.5 micromol/L
Standard Deviation 8.22
|
120.7 micromol/L
Standard Deviation 32.39
|
193.1 micromol/L
Standard Deviation 79.13
|
|
Plasma Concentration of Serine
Period 2 @ 3hrs
|
110.0 micromol/L
Standard Deviation 0
|
114.3 micromol/L
Standard Deviation 0
|
88.03 micromol/L
Standard Deviation 12.96
|
102.7 micromol/L
Standard Deviation 6.77
|
77.26 micromol/L
Standard Deviation 9.07
|
100.9 micromol/L
Standard Deviation 8.89
|
|
Plasma Concentration of Serine
Period 2 @ 4.5hrs
|
107.8 micromol/L
Standard Deviation 0
|
132.7 micromol/L
Standard Deviation 0
|
105.1 micromol/L
Standard Deviation 7.08
|
170.6 micromol/L
Standard Deviation 14.82
|
123.6 micromol/L
Standard Deviation 11.21
|
192.3 micromol/L
Standard Deviation 51.81
|
|
Plasma Concentration of Serine
Period 2 @ 7hrs
|
118.0 micromol/L
Standard Deviation 0
|
155.4 micromol/L
Standard Deviation 0
|
109.6 micromol/L
Standard Deviation 25.36
|
165.1 micromol/L
Standard Deviation 30.39
|
126.5 micromol/L
Standard Deviation 5.98
|
211.2 micromol/L
Standard Deviation 75.94
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: No data available as no data for this outcome measure were collected during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Threonine
Period 1 @ 3hrs
|
209.6 micromol/L
Standard Deviation 0
|
93.40 micromol/L
Standard Deviation 29.19
|
79.93 micromol/L
Standard Deviation 35.53
|
119.5 micromol/L
Standard Deviation 16.03
|
100.2 micromol/L
Standard Deviation 39.51
|
154.2 micromol/L
Standard Deviation 24.56
|
|
Plasma Concentration of Threonine
Period 1 @ 4.5hrs
|
266.7 micromol/L
Standard Deviation 0
|
94.60 micromol/L
Standard Deviation 37.36
|
129.1 micromol/L
Standard Deviation 27.90
|
181.3 micromol/L
Standard Deviation 40.39
|
160.1 micromol/L
Standard Deviation 26.40
|
290.7 micromol/L
Standard Deviation 118.3
|
|
Plasma Concentration of Threonine
Period 1 @ 7hrs
|
260.7 micromol/L
Standard Deviation 0
|
107.5 micromol/L
Standard Deviation 24.62
|
161.6 micromol/L
Standard Deviation 37.56
|
202.6 micromol/L
Standard Deviation 35.70
|
162.5 micromol/L
Standard Deviation 16.42
|
362.0 micromol/L
Standard Deviation 197.0
|
|
Plasma Concentration of Threonine
Period 2 @ 3hrs
|
208.7 micromol/L
Standard Deviation 0
|
121.9 micromol/L
Standard Deviation 0
|
94.87 micromol/L
Standard Deviation 27.61
|
128.8 micromol/L
Standard Deviation 22.22
|
111.7 micromol/L
Standard Deviation 4.21
|
176.6 micromol/L
Standard Deviation 61.58
|
|
Plasma Concentration of Threonine
Period 2 @ 4.5hrs
|
210.6 micromol/L
Standard Deviation 0
|
152.3 micromol/L
Standard Deviation 0
|
135.2 micromol/L
Standard Deviation 31.78
|
222.4 micromol/L
Standard Deviation 29.51
|
193.7 micromol/L
Standard Deviation 45.62
|
337.9 micromol/L
Standard Deviation 146.8
|
|
Plasma Concentration of Threonine
Period 2 @ 7hrs
|
223.6 micromol/L
Standard Deviation 0
|
183.8 micromol/L
Standard Deviation 0
|
148.4 micromol/L
Standard Deviation 55.95
|
248.5 micromol/L
Standard Deviation 71.49
|
211.4 micromol/L
Standard Deviation 75.37
|
363.8 micromol/L
Standard Deviation 179.8
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Tyrosine
Period 1 @ 3hrs
|
78.10 micromol/L
Standard Deviation 0
|
67.08 micromol/L
Standard Deviation 22.47
|
58.22 micromol/L
Standard Deviation 3.82
|
60.28 micromol/L
Standard Deviation 14.06
|
51.25 micromol/L
Standard Deviation 10.35
|
85.15 micromol/L
Standard Deviation 14.45
|
|
Plasma Concentration of Tyrosine
Period 1 @ 4.5hrs
|
71.64 micromol/L
Standard Deviation 0
|
53.42 micromol/L
Standard Deviation 16.60
|
63.50 micromol/L
Standard Deviation 6.52
|
60.03 micromol/L
Standard Deviation 9.87
|
58.22 micromol/L
Standard Deviation 7.83
|
86.43 micromol/L
Standard Deviation 19.95
|
|
Plasma Concentration of Tyrosine
Period 1 @ 7hrs
|
60.88 micromol/L
Standard Deviation 0
|
54.88 micromol/L
Standard Deviation 25.08
|
62.50 micromol/L
Standard Deviation 5.36
|
51.26 micromol/L
Standard Deviation 5.37
|
52.90 micromol/L
Standard Deviation 5.96
|
80.88 micromol/L
Standard Deviation 24.13
|
|
Plasma Concentration of Tyrosine
Period 2 @ 3hrs
|
64.19 micromol/L
Standard Deviation 0
|
66.48 micromol/L
Standard Deviation 0
|
53.81 micromol/L
Standard Deviation 4.30
|
67.60 micromol/L
Standard Deviation 4.60
|
55.68 micromol/L
Standard Deviation 8.37
|
88.24 micromol/L
Standard Deviation 25.57
|
|
Plasma Concentration of Tyrosine
Period 2 @ 4.5hrs
|
55.47 micromol/L
Standard Deviation 0
|
67.91 micromol/L
Standard Deviation 0
|
50.02 micromol/L
Standard Deviation 3.79
|
73.08 micromol/L
Standard Deviation 0.53
|
58.20 micromol/L
Standard Deviation 17.76
|
99.76 micromol/L
Standard Deviation 32.81
|
|
Plasma Concentration of Tyrosine
Period 2 @ 7hrs
|
54.80 micromol/L
Standard Deviation 0
|
78.05 micromol/L
Standard Deviation 0
|
44.42 micromol/L
Standard Deviation 7.00
|
71.62 micromol/L
Standard Deviation 8.59
|
52.24 micromol/L
Standard Deviation 20.36
|
105.4 micromol/L
Standard Deviation 46.80
|
SECONDARY outcome
Timeframe: Three times during each 7 hour visitPopulation: One subject completed Period 1, but withdrew from the study prior to the start of Period 2.
Outcome measures
| Measure |
15% CLINISOL 0.04 g/kg/hr (AB)
n=1 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.04 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)
|
15% CLINISOL 0.13 g/kg/hr (AB)
n=2 Participants
Sequence AB - without Insulin first, then with Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr (BA)
n=2 Participants
Sequence BA - with Insulin first, then no Insulin
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Valine
Period 1 @ 7hrs
|
281.1 micromol/L
Standard Deviation 0
|
186.6 micromol/L
Standard Deviation 4.18
|
356.2 micromol/L
Standard Deviation 63.52
|
332.7 micromol/L
Standard Deviation 27.59
|
353.9 micromol/L
Standard Deviation 17.09
|
663.9 micromol/L
Standard Deviation 260.3
|
|
Plasma Concentration of Valine
Period 2 @ 7hrs
|
230.1 micromol/L
Standard Deviation 0
|
248.4 micromol/L
Standard Deviation 0
|
241.1 micromol/L
Standard Deviation 226.3
|
433.4 micromol/L
Standard Deviation 31.96
|
399.8 micromol/L
Standard Deviation 178.2
|
635.1 micromol/L
Standard Deviation 159.6
|
|
Plasma Concentration of Valine
Period 1 @ 3hrs
|
187.6 micromol/L
Standard Deviation 0
|
165.6 micromol/L
Standard Deviation 11.94
|
159.6 micromol/L
Standard Deviation 44.44
|
171.7 micromol/L
Standard Deviation 9.35
|
179.8 micromol/L
Standard Deviation 45.09
|
245.5 micromol/L
Standard Deviation 3.68
|
|
Plasma Concentration of Valine
Period 1 @ 4.5hrs
|
257.6 micromol/L
Standard Deviation 0
|
167.8 micromol/L
Standard Deviation 22.42
|
260.2 micromol/L
Standard Deviation 50.23
|
282.0 micromol/L
Standard Deviation 8.70
|
296.2 micromol/L
Standard Deviation 15.89
|
477.7 micromol/L
Standard Deviation 125.8
|
|
Plasma Concentration of Valine
Period 2 @ 3hrs
|
177.1 micromol/L
Standard Deviation 0
|
136.7 micromol/L
Standard Deviation 0
|
177.5 micromol/L
Standard Deviation 88.16
|
177.4 micromol/L
Standard Deviation 38.16
|
199.1 micromol/L
Standard Deviation 7.82
|
264.2 micromol/L
Standard Deviation 11.62
|
|
Plasma Concentration of Valine
Period 2 @ 4.5hrs
|
208.4 micromol/L
Standard Deviation 0
|
188.7 micromol/L
Standard Deviation 0
|
247.3 micromol/L
Standard Deviation 110.0
|
323.7 micromol/L
Standard Deviation 45.42
|
338.1 micromol/L
Standard Deviation 84.89
|
480.9 micromol/L
Standard Deviation 71.82
|
Adverse Events
15% CLINISOL 0.04 g/kg/hr
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
15% CLINISOL 0.08 g/kg/hr
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
15% CLINISOL 0.13 g/kg/hr
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15% CLINISOL 0.04 g/kg/hr
n=3 participants at risk
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
15% CLINISOL 0.08 g/kg/hr
n=4 participants at risk
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
15% CLINISOL 0.13 g/kg/hr
n=4 participants at risk
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
15% CLINISOL - Sulfite-free (Amino Acid) Injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
AE analysis provided for all subjects who were exposed to study treatment.
|
0.00%
0/4
AE analysis provided for all subjects who were exposed to study treatment.
|
0.00%
0/4
AE analysis provided for all subjects who were exposed to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1
AE analysis provided for all subjects who were exposed to study treatment.
|
0.00%
0/4
AE analysis provided for all subjects who were exposed to study treatment.
|
0.00%
0/4
AE analysis provided for all subjects who were exposed to study treatment.
|
Additional Information
Aparna Valluru, Clinical Project Manager
Baxter Healthcare
Phone: 224.270.6063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER