Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting

The goal of the current study is to determine difference in glycemic control between traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly encountered in the investigators county hospital setting which include newly diagnosed type 2 patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight. Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: NPH and regular insulin; Drug: glargine and humalog

Detailed Description

The effect of insulin depends not only on the pharmacokinetics and pharmacodynamics of a particular preparation, but also on patient specific factors which includes state of inflammation, obesity etc. Although effect on glucose disposal is the central to insulin action, there could be differences of insulin action on other metabolic parameters. It is not known if there is a difference in suppression of inflammation with improved glycemic control which could vary with analog insulin. It is unknown if natural insulin (NPH, recombinant human insulin with protamine) differs from insulin analogs (glargine and detemir, made by substituting amino acid in the native sequence) in terms of metabolic outcome other than glucose disposal.

At this point it is uncertain if there is any clear benefit of use of lantus over NPH in inpatient glycemic management. Currently, both lantus and NPH based regimen is practiced in inpatient hospital setting. Current practice of inpatient insulin regimen is based more on familiarity of physicians with a particular insulin type and personal preference rather than evidenced based knowledge. Lantus is an expensive insulin preparation compared to NPH with uncertain benefit in inpatient setting. Current research proposal will compare this two insulin based regimen in the management of diabetes of hospitalized patients. Information obtained through this research will guide the investigators practice in this institution as well as in other institutions.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Moreno Valley, California, United States, 92555
      • Riverside County Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with type II diabetes regardless of duration of diagnosis with an admission blood glucose level between 140 mg/dL to 400 mg/dL will be included in the study.

• Other inclusion criteria are as follows:

  • age 18-80 years old
  • treated with diet alone
  • any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.

Exclusion Criteria:

• Hyperglycemia without a known history of diabetes
• H/o recent cardiac surgery (within 6 months)
• Impaired renal function (glomerular filtration rate less than 45)
• History of diabetic ketoacidosis
• Diabetes mellitus type 1
• Pregnancy
• Patients on steroid treatment
• Known hypopituitarism or adrenal insufficiency
• Known hypoglycemia of unawareness
• Length of stay <48 h
• And severe liver disease and patent admitted in intensive care unit.
• Patients already received an insulin dose greater than 0.5 units/kg body weight after admission prior to initiation of study protocol will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPH and regular insuline group; For the group receiving NPH and regular 2/3 and 1/3 formula will be followed. If Nil per os (NPO), patient will receive NPH twice daily but AM dose will equal to PM dose. Regular insulin given along with NPH will be held while patient is NPO. A correctional dose of regular insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they could also receive correctional doses of regular insulin. Correctional insulin could be given four times daily with meals or at bedtime.	Drug: NPH and regular insulin
Active Comparator: glargine and humalog group; Half of the total insulin dose will be given as glargine once daily, either in the AM or in the PM, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as humalog; doses were divided equally between breakfast, lunch, and dinner. An additional correctional dose of humalog will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and could also receive correctional doses of humalog. Correctional humalog could be given four times daily with meals or at bedtime.	Drug: glargine and humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in glycemic control between treatment groups as measured by the mean daily blood glucose	Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose	Duration of hospital stay, up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of hypoglycemic events	number of hypoglycemic events	duration of hospital stay, up to 24 weeks

Collaborators and Investigators

• Sponsor: Riverside University Health System Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Type 2 diabetes; insulin; glargine; NPH; Uncontrolled blood glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: 437860