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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Riverside County Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Iqbal Munir, MD, PhD, Riverside County Regional Medical Center
ClinicalTrials.gov Identifier:
NCT02189395
First received: July 9, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: NPH and regular insulin
Drug: glargine and humalog
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting

Resource links provided by NLM:


Further study details as provided by Riverside County Regional Medical Center:

Primary Outcome Measures:
  • difference in glycemic control between treatment groups as measured by the mean daily blood glucose [ Time Frame: Duration of hospital stay, up to 24 weeks ] [ Designated as safety issue: No ]
    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 Measures:
  • number of hypoglycemic events [ Time Frame: duration of hospital stay, up to 24 weeks ] [ Designated as safety issue: Yes ]
    number of hypoglycemic events


Estimated Enrollment: 130
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189395

Contacts
Contact: Iqbal Munir, MD, PhD 951-486-5857 imunir@co.riverside.ca.us
Contact: Hayley Lee, MPH 951-486-5857 haylee@co.riverside.ca.us

Locations
United States, California
Riverside County Regional Medical Center Recruiting
Moreno Valley, California, United States, 92555
Contact: Iqbal Munir, MD    951-486-5857    imunir@co.riverside.ca.us   
Contact: Hayley Lee, MPH    951-486-5857    haylee@co.riverside.ca.us   
Principal Investigator: Iqbal Munir, MD, PhD         
Sponsors and Collaborators
Riverside County Regional Medical Center
  More Information

No publications provided

Responsible Party: Iqbal Munir, MD, PhD, Principal Investigator, Riverside County Regional Medical Center
ClinicalTrials.gov Identifier: NCT02189395     History of Changes
Other Study ID Numbers: 437860
Study First Received: July 9, 2014
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Riverside County Regional Medical Center:
Type 2 diabetes
Uncontrolled blood glucose
insulin
glargine
NPH

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014