Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
| Registry | NCT03511521 |
|---|---|
| Status | Terminated - Unable to recruit sufficient number of patients |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 3 (Actual) |
| Sponsor | Northwestern University (Other) |
| Conditions | Hyperglycemia Steroid-induced, Insulin Resistance, Diabetes |
| Interventions | NPH Insulin, glargine, Insulin Aspart (Drug) |
| Dates | start 2018-03-27, primary completion 2019-08-15, completion 2019-08-15, first posted 2018-04-27, last updated 2020-09-11 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Hyperglycemia Steroid-induced All trials for Insulin Resistance, Diabetes All trials of NPH Insulin All trials of glargine
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| NPH Insulin | Experimental | Drug: NPH Insulin; Drug: glargine; Drug: Insulin Aspart | 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. |
| Basal/Bolus Insulin | Active comparator | 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. |
Sex: All, ages: 18 Years to any
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
| Milestone | NPH Insulin | Basal/Bolus Insulin |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
Time frame: 3 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| NPH Insulin | 0/2 (0.0%) | 0/2 (0.0%) | 0/2 (0.0%) |
| Basal/Bolus Insulin | 0/1 (0.0%) | 0/1 (0.0%) | 0/1 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago, Illinois | United States |