A Phase 4 interventional study of NPH Insulin and glargine in Hyperglycemia Steroid-induced and Insulin Resistance, Diabetes, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions. There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin, an intermediate-acting insulin, given at the time of steroid administration to the patient's standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen which will consist primarily increasing the prandial doses at lunch and supper in order to determine which regimen is superior for glycemic control.
Inpatients who will receive single daily doses of prednisone or methylprednisolone for treatment of their underlying condition and who become hyperglycemic will be eligible. Subjects will be randomized in a 1:1 fashion to one of two arms: (1) to their standard basal bolus insulin the addition of NPH insulin given at the time of the steroid adminstration, adjusting the dose based on the dose of steroid; (2) an increase in the basal and prandial bolus insulin doses based on the dose of steroid. Glycemic control and the incidence of hypoglycemia will be assessed over the first 3 days after initiating these insulin regimens.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
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Exclusion Criteria:
NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses: Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; \>80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone.
Drug: NPH Insulin · Drug: glargine · Drug: Insulin Aspart
Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U \[units\]/kg) according to the Prednisone dose (mg/day) as follows: Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone \>80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.
Drug: glargine · Drug: Insulin Aspart
Intermediate acting insulin
Also known as: Humulin N, Novolin N
basal insulin
Also known as: Lantus, Basaglar
prandial insulin
Also known as: Novolog
Glycemic Control
mean of 4 glucose levels per day (premeal and bedtime) for each group for first 3 days after intervention
Time frame: 3 days
Percentage of Glucose Values Within Therapeutic Range
Percentage of the glucose values (premeal and bedtime for 3 days) within the therapeutic target of 80 - 180 mg/dL
Time frame: 3 days
Percentage of Glucose Values Within the Hypoglycemic Range
Percentage of the glucose values (premeal and bedtime for 3 days) less than 70 mg/dL and 54 mg/dL
Time frame: 3 days
| Milestone | NPH Insulin | Basal/Bolus Insulin |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
mean of 4 glucose levels per day (premeal and bedtime) for each group for first 3 days after intervention
| mg/dL | NPH Insulin | Basal/Bolus Insulin |
|---|---|---|
| Glycemic Control | 284.3 ± 81.0 | 184.3 ± 61.8 |
Percentage of the glucose values (premeal and bedtime for 3 days) within the therapeutic target of 80 - 180 mg/dL
| percentage of glucose values in range | NPH Insulin | Basal/Bolus Insulin |
|---|---|---|
| Percentage of Glucose Values Within Therapeutic Range | 4.2 (3.4 to 5.0) | 50 (19 to 81) |
Percentage of the glucose values (premeal and bedtime for 3 days) less than 70 mg/dL and 54 mg/dL
| Percentage of glucose values < 70 mg/dL | NPH Insulin | Basal/Bolus Insulin |
|---|---|---|
| Percentage of Glucose Values Within the Hypoglycemic Range | 0 (0 to 0) | 0 (0 to 0) |
Collected over 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPH Insulin | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Basal/Bolus Insulin | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| Mean | 57.5 ± 1.5 | 36 ± 0 | 50.3 ± 10.2 |
| Sex: Female, Male(Participants) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
| Initial Glucose(mg/dL) | NPH Insulin | Basal/Bolus Insulin | Total |
|---|---|---|---|
| Mean | 244 ± 4 | 80 ± 0 | 189 ± 77.4 |
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