Trial Outcomes & Findings for The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients (NCT NCT01810952)
NCT ID: NCT01810952
Last Updated: 2017-02-08
Results Overview
Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
1-5 days
Results posted on
2017-02-08
Participant Flow
Participants were identified from admission listing of patients and admitting diagnoses. Admitting physician was contacted to determine eligibility and if s/he were agreeable to our approaching patient regarding the study. Protocol was explained to patient. If s/he agreed to participate, they were asked to sign an informed consent.
Participant milestones
| Measure |
Glargine/Lispro Insulin
The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin
The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Baseline characteristics by cohort
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Continuous
Baseline Participants
|
60.8 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
67.1 years
STANDARD_DEVIATION 14.3 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 13.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
37 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1-5 daysPopulation: We used t-tests to compare values between the protocols on each day..
Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."
Outcome measures
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
|
|---|---|---|
|
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Day 1 (n=20, 17)
|
181.8 mg/dL
Standard Deviation 40.9
|
173.7 mg/dL
Standard Deviation 51.2
|
|
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Day 2 (n=20, 17)
|
160.5 mg/dL
Standard Deviation 45.5
|
148.4 mg/dL
Standard Deviation 36.7
|
|
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Day 3 (n=20, 17)
|
155.1 mg/dL
Standard Deviation 51.8
|
140.8 mg/dL
Standard Deviation 35.2
|
|
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Day 4 (n=14, 12)
|
159.5 mg/dL
Standard Deviation 40.5
|
133.4 mg/dL
Standard Deviation 34.0
|
|
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Day 5 (n=10, 7)
|
151.7 mg/dL
Standard Deviation 45.5
|
132.0 mg/dL
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: Last Full Day of Protocol for Participant (up to Day 5)Percent of Participants with Average Daily Glucose \>70 and \<180 mg/dL
Outcome measures
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
|
|---|---|---|
|
Percent of Participants With Average Glucose >70 and <180 mg/dL
|
90 percentage of participants
|
94 percentage of participants
|
SECONDARY outcome
Timeframe: 1-5 daysTotal daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL
Outcome measures
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
|
|---|---|---|
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Daily Insulin Dose/Kg Body Weight
Day 1 (n=20, 17)
|
0.89 units of insulin/Kg body weight
Standard Deviation 0.25
|
0.80 units of insulin/Kg body weight
Standard Deviation 0.17
|
|
Daily Insulin Dose/Kg Body Weight
Day 2 (n=20, 17)
|
0.91 units of insulin/Kg body weight
Standard Deviation 0.28
|
0.82 units of insulin/Kg body weight
Standard Deviation 0.18
|
|
Daily Insulin Dose/Kg Body Weight
Day 3 (n=20, 17)
|
0.96 units of insulin/Kg body weight
Standard Deviation 0.35
|
0.77 units of insulin/Kg body weight
Standard Deviation 0.24
|
|
Daily Insulin Dose/Kg Body Weight
Day 4 (n=14, 12)
|
1.01 units of insulin/Kg body weight
Standard Deviation 0.50
|
0.75 units of insulin/Kg body weight
Standard Deviation 0.16
|
|
Daily Insulin Dose/Kg Body Weight
Day 5 (n=10, 7)
|
1.12 units of insulin/Kg body weight
Standard Deviation 0.70
|
0.65 units of insulin/Kg body weight
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 1-5 days\# participants with glucose values \<70 mg/dL
Outcome measures
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
|
|---|---|---|
|
Glucose Values <70 mg/dL.
# with glucose values <60 mg/dL
|
4 participants
|
2 participants
|
|
Glucose Values <70 mg/dL.
# with glucose values <70 mg/dL
|
5 participants
|
4 participants
|
|
Glucose Values <70 mg/dL.
# with glucose <50
|
1 participants
|
0 participants
|
POST_HOC outcome
Timeframe: 1-5 daysOutcome measures
| Measure |
Glargine/Lispro Insulin Arm
n=20 Participants
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 Participants
Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
|
|---|---|---|
|
Percent of Glucose Determinations >180 mg/dL
|
31.0 Percent of glucose values
|
24.6 Percent of glucose values
|
Adverse Events
Glargine/Lispro Insulin Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Glargine/Lispro/NPH Insulin Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glargine/Lispro Insulin Arm
n=20 participants at risk
The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL.
|
Glargine/Lispro/NPH Insulin Arm
n=17 participants at risk
The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
|
|---|---|---|
|
Endocrine disorders
Glucose value <50 mg/dL.
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place