Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Insulin Resistance, Diabetes Clinical Trial

Official title:

Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03511521
• Other study ID #: STU00207079
• Status: Terminated
• Phase: Phase 4
• Start date: March 27, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Steroid-induced
• Insulin Resistance
• Insulin Resistance, Diabetes

Intervention

Drug:
• NPH Insulin
Intermediate acting insulin
• glargine
basal insulin
• Insulin Aspart
prandial insulin

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. 2 — View 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: — View 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. — View Citation

Ruiz de Adana MS, Colomo N, Maldonado-Araque C, Fontalba MI, Linares F, García-Torres F, Fernández R, Bautista C, Olveira G, de la Cruz JL, Rojo-Martínez G, Valdés S. Randomized clinical trial of the efficacy and safety of insulin glargine vs. NPH insulin — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	mean of 4 glucose levels per day (premeal and bedtime) for each group for first 3 days after intervention	3 days
Secondary	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	3 days
Secondary	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	3 days