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

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

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

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=99 Participants
60.0 years
STANDARD_DEVIATION 11.4 • n=107 Participants
59.4 years
STANDARD_DEVIATION 11.4 • n=206 Participants
Sex: Female, Male
Female
29 Participants
n=99 Participants
25 Participants
n=107 Participants
54 Participants
n=206 Participants
Sex: Female, Male
Male
23 Participants
n=99 Participants
25 Participants
n=107 Participants
48 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian
52 Participants
n=99 Participants
50 Participants
n=107 Participants
102 Participants
n=206 Participants
Past history of Diabetes
41 Participants
n=99 Participants
45 Participants
n=107 Participants
86 Participants
n=206 Participants
NIHSS score
16 units on a scale
STANDARD_DEVIATION 6 • n=99 Participants
15 units on a scale
STANDARD_DEVIATION 7 • n=107 Participants
15 units on a scale
STANDARD_DEVIATION 6 • n=206 Participants
GCS score
11 units on a scale
STANDARD_DEVIATION 3 • n=99 Participants
11 units on a scale
STANDARD_DEVIATION 3 • n=107 Participants
11 units on a scale
STANDARD_DEVIATION 3 • n=206 Participants
Systolic blood pressure
146 mm of Hg
STANDARD_DEVIATION 20 • n=99 Participants
147 mm of Hg
STANDARD_DEVIATION 24 • n=107 Participants
146 mm of Hg
STANDARD_DEVIATION 22 • n=206 Participants
Diastolic blood pressure
91 mm of Hg
STANDARD_DEVIATION 13 • n=99 Participants
89 mm of Hg
STANDARD_DEVIATION 13 • n=107 Participants
90 mm of Hg
STANDARD_DEVIATION 13 • n=206 Participants
HbA1c
9.9 %
STANDARD_DEVIATION 2.8 • n=99 Participants
10.2 %
STANDARD_DEVIATION 2.2 • n=107 Participants
10.0 %
STANDARD_DEVIATION 2.5 • n=206 Participants
S. Creatinine
1.13 mg/dL
STANDARD_DEVIATION 0.53 • n=99 Participants
1.19 mg/dL
STANDARD_DEVIATION 0.61 • n=107 Participants
1.15 mg/dL
STANDARD_DEVIATION 0.56 • n=206 Participants
Feeding pattern on admission
Nasogastric tube feeding
26 Participants
n=99 Participants
34 Participants
n=107 Participants
60 Participants
n=206 Participants
Feeding pattern on admission
Oral feeding
14 Participants
n=99 Participants
11 Participants
n=107 Participants
25 Participants
n=206 Participants
Feeding pattern on admission
Nothing per oral
12 Participants
n=99 Participants
5 Participants
n=107 Participants
17 Participants
n=206 Participants
Feeding pattern during outcome
Nasogastric tube feeding
24 Participants
n=99 Participants
26 Participants
n=107 Participants
50 Participants
n=206 Participants
Feeding pattern during outcome
Oral feeding
20 Participants
n=99 Participants
18 Participants
n=107 Participants
38 Participants
n=206 Participants
Feeding pattern during outcome
Nothing per oral
8 Participants
n=99 Participants
6 Participants
n=107 Participants
14 Participants
n=206 Participants
Use of steroids
20 Participants
n=99 Participants
20 Participants
n=107 Participants
40 Participants
n=206 Participants
Stroke type
Ischemic
28 Participants
n=99 Participants
24 Participants
n=107 Participants
52 Participants
n=206 Participants
Stroke type
Hemorrhagic
24 Participants
n=99 Participants
26 Participants
n=107 Participants
50 Participants
n=206 Participants
NIHSS category
Score 1-4
3 Participants
n=99 Participants
4 Participants
n=107 Participants
7 Participants
n=206 Participants
NIHSS category
Score 5-15
14 Participants
n=99 Participants
19 Participants
n=107 Participants
33 Participants
n=206 Participants
NIHSS category
Score 16-20
27 Participants
n=99 Participants
19 Participants
n=107 Participants
46 Participants
n=206 Participants
NIHSS category
Score 21-42
8 Participants
n=99 Participants
8 Participants
n=107 Participants
16 Participants
n=206 Participants

PRIMARY outcome

Timeframe: During the hospital stay assessed up to 10 days

Population: 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

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 days

Total daily dose of insulin is calculated according to total basal insulin dose plus total bolus insulin dose divided by days of treatment

Outcome measures

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 days

Length of hospital stay of the study participants

Outcome measures

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 days

In-hospital mortality of the study participants

Outcome measures

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

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place