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

NCT02189395 | Terminated Phase 4 DMC

• 1 other identifier: 437860
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; Uncontrolled blood glucose; insulin; glargine; NPH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of hypoglycemic events

  duration of hospital stay, up to 24 weeks

Study Arms (2)

NPH and regular insuline group

EXPERIMENTAL

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

glargine and humalog group

ACTIVE COMPARATOR

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

Interventions

NPH and regular insulin DRUG

NPH and regular insuline group

glargine and humalog DRUG

glargine and humalog group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

Study Sites (1)

Riverside County Regional Medical Center

Moreno Valley, California, 92555, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulin, Short-Acting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

US (1)