Trial Outcomes & Findings for Insulin for Hyperglycemia in Stroke Trial (NCT NCT04834362)
NCT ID: NCT04834362
Last Updated: 2021-12-06
Results Overview
Differences in glycemic control between groups, as measured by mean blood glucose concentration
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
452 participants
Primary outcome timeframe
During the hospital stay assessed up to 10 days
Results posted on
2021-12-06
Participant Flow
Participants admitted to the study center with acute stroke were enrolled between April 2021 and June 2021. The first participant was enrolled on April 04, 2021 and the last participant was enrolled on June 14, 2021.
Of 452 enrolled participants, 105 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Analog Insulin Arm
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Analog Insulin Arm
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
Insulin for Hyperglycemia in Stroke Trial
Baseline characteristics by cohort
| Measure |
Analog Insulin Arm
n=52 Participants
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 Participants
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Past history of Diabetes
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
NIHSS score
|
16 units on a scale
STANDARD_DEVIATION 6 • n=5 Participants
|
15 units on a scale
STANDARD_DEVIATION 7 • n=7 Participants
|
15 units on a scale
STANDARD_DEVIATION 6 • n=5 Participants
|
|
GCS score
|
11 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
11 units on a scale
STANDARD_DEVIATION 3 • n=7 Participants
|
11 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Systolic blood pressure
|
146 mm of Hg
STANDARD_DEVIATION 20 • n=5 Participants
|
147 mm of Hg
STANDARD_DEVIATION 24 • n=7 Participants
|
146 mm of Hg
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Diastolic blood pressure
|
91 mm of Hg
STANDARD_DEVIATION 13 • n=5 Participants
|
89 mm of Hg
STANDARD_DEVIATION 13 • n=7 Participants
|
90 mm of Hg
STANDARD_DEVIATION 13 • n=5 Participants
|
|
HbA1c
|
9.9 %
STANDARD_DEVIATION 2.8 • n=5 Participants
|
10.2 %
STANDARD_DEVIATION 2.2 • n=7 Participants
|
10.0 %
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
S. Creatinine
|
1.13 mg/dL
STANDARD_DEVIATION 0.53 • n=5 Participants
|
1.19 mg/dL
STANDARD_DEVIATION 0.61 • n=7 Participants
|
1.15 mg/dL
STANDARD_DEVIATION 0.56 • n=5 Participants
|
|
Feeding pattern on admission
Nasogastric tube feeding
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Feeding pattern on admission
Oral feeding
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Feeding pattern on admission
Nothing per oral
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Feeding pattern during outcome
Nasogastric tube feeding
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Feeding pattern during outcome
Oral feeding
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Feeding pattern during outcome
Nothing per oral
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Use of steroids
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Stroke type
Ischemic
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Stroke type
Hemorrhagic
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
NIHSS category
Score 1-4
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
NIHSS category
Score 5-15
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
NIHSS category
Score 16-20
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
NIHSS category
Score 21-42
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the hospital stay assessed up to 10 daysPopulation: According to inclusion and exclusion criteria 105 patients were randomized in the study. Of them 102 were analyzed at the end of trial. 52 received analog insulin and 50 received human insulin.
Differences in glycemic control between groups, as measured by mean blood glucose concentration
Outcome measures
| Measure |
Analog Insulin Arm
n=52 Participants
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 Participants
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Glycemic Control
|
10.7 mmol/L
Standard Deviation 2.9
|
10.9 mmol/L
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: During the hospital stay assessed up to 10 daysTotal daily dose of insulin is calculated according to total basal insulin dose plus total bolus insulin dose divided by days of treatment
Outcome measures
| Measure |
Analog Insulin Arm
n=52 Participants
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 Participants
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Total Daily Dose of Insulin
|
22.3 Units/day
Standard Deviation 8.8
|
26.7 Units/day
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: During the hospital stay assessed up to 10 daysLength of hospital stay of the study participants
Outcome measures
| Measure |
Analog Insulin Arm
n=52 Participants
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 Participants
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Length of Hospital Stay
|
4.7 Days
Standard Deviation 2.5
|
4.8 Days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: During the hospital stay assessed up to 10 daysIn-hospital mortality of the study participants
Outcome measures
| Measure |
Analog Insulin Arm
n=52 Participants
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 Participants
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Mortality
|
15 Participants
|
16 Participants
|
Adverse Events
Analog Insulin Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 15 deaths
Human Insulin Arm
Serious events: 0 serious events
Other events: 10 other events
Deaths: 16 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Analog Insulin Arm
n=52 participants at risk
Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.
Analog Insulin: For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.
|
Human Insulin Arm
n=50 participants at risk
Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm
Human insulin: Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
|
|---|---|---|
|
Investigations
Hypoglycemia
|
17.3%
9/52 • Number of events 10 • During the period of hospitalization, up to 10 days.
|
20.0%
10/50 • Number of events 15 • During the period of hospitalization, up to 10 days.
|
Additional Information
Dr. Mashfiqul Hasan
National Institute of Neurosciences and Hospital, Dhaka
Phone: +8801816268746
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place