Trial Outcomes & Findings for A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8 (NCT NCT03337477)
NCT ID: NCT03337477
Last Updated: 2020-01-28
Results Overview
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline to 4h potassium measurements.
Results posted on
2020-01-28
Participant Flow
Participants took part in the study in the United States, Russia, Denmark and Italy from 13 February 2018 to 21 December 2018.
Patients with S-K ≥5.8 mmol/L for whom treatment with insulin and glucose to manage hyperkalaemia has been determined medically appropriate by the Investigator. The study originally recruited patients with S-K ≥6.0 mmol/L; however, this inclusion criterion was updated during CSP Amendment to allow enrolment of patients with S-K ≥5.8 mmol/L.
Participant milestones
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
SZC will be administered in addition to insulin and glucose.
|
Placebo
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
37
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
SZC will be administered in addition to insulin and glucose.
|
Placebo
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
Overall Study
not categorized into the listed ones
|
11
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Baseline characteristics by cohort
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=33 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=37 Participants
Placebo will be administered in addition to insulin and glucose.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
56.4 years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
59.0 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Age, Customized
<50 years
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Customized
>=50 - <65 years
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4h potassium measurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo
|
-0.41 mmol/L
Interval -0.63 to -0.19
|
-0.27 mmol/L
Interval -0.48 to -0.07
|
SECONDARY outcome
Timeframe: Baseline to 4h potassium meansurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment
|
0.063 Proportion of participants
|
0.056 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline to 4h potassium meansurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
1h
|
0.156 Proportion of participants
|
0.139 Proportion of participants
|
|
The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
2h
|
0.125 Proportion of participants
|
0.056 Proportion of participants
|
|
The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
4h
|
0.063 Proportion of participants
|
0.056 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline to 4h potassium meansurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
1h
|
0.313 Proportion of paticipants
|
0.306 Proportion of paticipants
|
|
The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
2h
|
0.375 Proportion of paticipants
|
0.167 Proportion of paticipants
|
|
The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
4h
|
0.156 Proportion of paticipants
|
0.139 Proportion of paticipants
|
SECONDARY outcome
Timeframe: Baseline to 4h potassium meansurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
1h
|
0.656 Proportion of paticipants
|
0.611 Proportion of paticipants
|
|
The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
2h
|
0.625 Proportion of paticipants
|
0.472 Proportion of paticipants
|
|
The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
4h
|
0.469 Proportion of paticipants
|
0.361 Proportion of paticipants
|
SECONDARY outcome
Timeframe: Baseline to 4h potassium meansurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.
|
0.156 Proportion of participants
|
0.306 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline to 2h potassium measurements.Population: Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g
n=32 Participants
SZC will be administered in addition to insulin and glucose.
|
Placebo
n=36 Participants
Placebo will be administered in addition to insulin and glucose.
|
|---|---|---|
|
Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo
1h
|
-0.67 mmol/L
Interval -0.9 to -0.44
|
-0.67 mmol/L
Interval -0.89 to -0.45
|
|
Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo
2h
|
-0.72 mmol/L
Interval -0.96 to -0.48
|
-0.36 mmol/L
Interval -0.59 to -0.14
|
Adverse Events
Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (0-24h)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (After 24 h)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h)
n=29 participants at risk
SZC will be administered in addition to insulin and glucose. AEs collected between 0-24h.
|
Placebo (0-24h)
n=33 participants at risk
Placebo will be administered in addition to insulin and glucose. AEs collected between 0-24h.
|
Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h)
n=29 participants at risk
SZC will be administered in addition to insulin and glucose. AEs collected after 24h.
|
Placebo (After 24 h)
n=33 participants at risk
Placebo will be administered in addition to insulin and glucose. AEs collected after 24h.
|
|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.0%
1/33 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Nervous system disorders
Clonic convulsion
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.0%
1/33 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.0%
1/33 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.4%
1/29 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.0%
1/33 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
6.1%
2/33 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.4%
1/29 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
3.4%
1/29 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
Other adverse events
| Measure |
Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h)
n=29 participants at risk
SZC will be administered in addition to insulin and glucose. AEs collected between 0-24h.
|
Placebo (0-24h)
n=33 participants at risk
Placebo will be administered in addition to insulin and glucose. AEs collected between 0-24h.
|
Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h)
n=29 participants at risk
SZC will be administered in addition to insulin and glucose. AEs collected after 24h.
|
Placebo (After 24 h)
n=33 participants at risk
Placebo will be administered in addition to insulin and glucose. AEs collected after 24h.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
13.8%
4/29 • Number of events 5 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
9.1%
3/33 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
6.1%
2/33 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
6.9%
2/29 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/29 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
6.9%
2/29 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
0.00%
0/33 • AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.
Patients at risk are the ones who got at least one dose, namely 29 in SZC and 33 in placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60