NCT03511521

Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperglycemia Steroid-induced
• Insulin Resistance, Diabetes

Interventions

Type	Name	Description
DRUG	NPH Insulin	Intermediate acting insulin
DRUG	glargine	basal insulin
DRUG	Insulin Aspart	prandial insulin

Timeline

• Start date: 2018-03-27
• Primary completion: 2019-08-15
• Completion: 2019-08-15
• First posted: 2018-04-27
• Last updated: 2020-09-11
• Results posted: 2020-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study