Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2019-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperglycemia Steroid-induced Insulin Resistance, Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients receiving single dose steroids who become hyperglycemic will be randomized to two treatment arms in a parallel design: (1) NPH added to basal/bolus insulin; (2) increase in doses of basal and bolus insulin

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPH Insulin

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.

Group Type EXPERIMENTAL

NPH Insulin

Intervention Type DRUG

Intermediate acting insulin

glargine

Intervention Type DRUG

basal insulin

Insulin Aspart

Intervention Type DRUG

prandial insulin

Basal/Bolus Insulin

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.

Group Type ACTIVE_COMPARATOR

glargine

Intervention Type DRUG

basal insulin

Insulin Aspart

Intervention Type DRUG

prandial insulin

Interventions

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NPH Insulin

Intermediate acting insulin

Intervention Type DRUG

glargine

basal insulin

Intervention Type DRUG

Insulin Aspart

prandial insulin

Intervention Type DRUG

Other Intervention Names

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Humulin N Novolin N Lantus Basaglar Novolog

Eligibility Criteria

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Inclusion Criteria

* Patients receiving once daily dosing of methylprednisolone or prednisone in a dose of 10 mg/day or greater
* Hyperglycemic (Glucose level \> 126 mg/dL)
* Diabetic and nondiabetic patients
* Expected duration of hospital stay and time on steroids \>= 3 days
* Patient of appropriate caregiver able to give Informed Consent

Exclusion Criteria

* Patients with 2 or more doses of methylprednisolone/prednisone per day
* Steroids other than methylprednisolone or prednisone
* Pregnancy
* estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No