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Trial record 20 of 667 for:    Recruiting, Not yet recruiting, Available Studies | "Insulins"

Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

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ClinicalTrials.gov Identifier: NCT03511521
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Steroid-induced Insulin Resistance, Diabetes Drug: NPH Insulin Drug: glargine Drug: Insulin Aspart Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : March 26, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: 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 (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.

Drug: NPH Insulin
Intermediate acting insulin
Other Names:
  • Humulin N
  • Novolin N

Drug: glargine
basal insulin
Other Names:
  • Lantus
  • Basaglar

Drug: Insulin Aspart
prandial insulin
Other Name: Novolog

Active Comparator: 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.

Drug: glargine
basal insulin
Other Names:
  • Lantus
  • Basaglar

Drug: Insulin Aspart
prandial insulin
Other Name: Novolog




Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 3 days ]
    mean of 4 glucose levels per day (premeal and bedtime) for each group for first 3 days after intervention


Secondary Outcome Measures :
  1. Proportions of glucose values within therapeutic range [ Time Frame: 3 days ]
    Proportions of the 12 glucose values (premeal and bedtime for 3 days) within the therapeutic targets of 80 - 140 and 80 - 180 mg/dL

  2. Proportions of glucose values within the hypoglycemic range [ Time Frame: 3 days ]
    Proportions of the 12 glucose values (premeal and bedtime for 3 days) less than 70 mg/dL and 54 mg/dL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511521


Contacts
Contact: Mark E Molitch, MD 312 503-4130 molitch@northwestern.edu
Contact: Amisha Wallia, MD 312 503-2756 a-wallia@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Smita Kumar, MD    312-695-1535    smita.kumar@northwestern.edu   
Sub-Investigator: Smita Kumar, MD         
Sub-Investigator: Kathleen Schmidt, APRN         
Sub-Investigator: Tiffany Grant, APRN         
Sub-Investigator: Erica Tayaban, APRN         
Sub-Investigator: Diana Johnson Oakes, APRN         
Sub-Investigator: Amisha Wallia, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mark Molitch, MD Northwestern University Feinberg School of Medicine

Publications of Results:

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03511521     History of Changes
Other Study ID Numbers: STU00207079
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Northwestern University:
steroid
prednisone
methylprednisolone
hyperglycemia
insulin
hypoglycemia

Additional relevant MeSH terms:
Insulin Resistance
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Isophane
Isophane Insulin, Human
Prednisone
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents