Clinical trial NCT03511521: Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Official title: Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyperglycemia Steroid-induced
Insulin Resistance, Diabetes
Keywords: steroid
prednisone
methylprednisolone
hyperglycemia
insulin
hypoglycemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic Control
timeFrame: 3 days
Secondary outcomes:
measure: Percentage of Glucose Values Within Therapeutic Range
timeFrame: 3 days
measure: Percentage of Glucose Values Within the Hypoglycemic Range
timeFrame: 3 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Mark Molitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhital SM, Shenker Y, Meredith M, Davis DB. A retrospective study comparing neutral protamine hagedorn insulin with glargine as basal therapy in prednisone-associated diabetes mellitus in hospitalized patients. Endocr Pract. 2012 Sep-Oct;18(5):712-9. doi: 10.4158/EP11371.OR.
citation: Ruiz de Adana MS, Colomo N, Maldonado-Araque C, Fontalba MI, Linares F, Garcia-Torres F, Fernandez R, Bautista C, Olveira G, de la Cruz JL, Rojo-Martinez G, Valdes S. Randomized clinical trial of the efficacy and safety of insulin glargine vs. NPH insulin as basal insulin for the treatment of glucocorticoid induced hyperglycemia using continuous glucose monitoring in hospitalized patients with type 2 diabetes and respiratory disease. Diabetes Res Clin Pract. 2015 Nov;110(2):158-65. doi: 10.1016/j.diabres.2015.09.015. Epub 2015 Sep 30.
citation: Radhakutty A, Stranks JL, Mangelsdorf BL, Drake SM, Roberts GW, Zimmermann AT, Stranks SN, Thompson CH, Burt MG. Treatment of prednisolone-induced hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study. Diabetes Obes Metab. 2017 Apr;19(4):571-578. doi: 10.1111/dom.12859. Epub 2017 Feb 17.
citation: Bevier WC, Zisser HC, Jovanovic L, Finan DA, Palerm CC, Seborg DE, Doyle FJ 3rd. Use of continuous glucose monitoring to estimate insulin requirements in patients with type 1 diabetes mellitus during a short course of prednisone. J Diabetes Sci Technol. 2008 Jul;2(4):578-83. doi: 10.1177/193229680800200408.
citation: Seggelke SA, Gibbs J, Draznin B. Pilot study of using neutral protamine Hagedorn insulin to counteract the effect of methylprednisolone in hospitalized patients with diabetes. J Hosp Med. 2011 Mar;6(3):175-6. doi: 10.1002/jhm.874. No abstract available.