The Inova Type 2 Diabetes Mellitus Study

NCT02222623 | Withdrawn

• 1 other identifier: 14-1623
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and effectiveness of the two different basal insulins commonly used for basal blood sugar control in the treatment of type 2 diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of blood sugar in a type 2 diabetic patient. This research is being done because the costs of medications for diabetic patients are very expensive. Our goal with this research is to show that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin \[glargine (Lantus®)\] in patients with type 2 diabetes mellitus who are in the hospital.

Conditions

Diabetes, Type 2

Keywords

insulin; basal; diabetes; hospital; glucose; hypoglycemia; glargine; NPH; neutral protamine hagedorn

Outcome Measures

Primary Outcomes (1)

• Mean daily blood glucose

  5 days

Secondary Outcomes (4)

• Percent of total BG readings within target BG 70-180 mg/dL before meals.

  5 days

• Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL)

  5 days

• Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment.

  5 days

• Hospital mortality

  5 days

Other Outcomes (2)

• Mean total daily dose of insulin

  5 days

• Length of hospital stay

  within first 30 days of admission

Study Arms (2)

glargine insulin

ACTIVE COMPARATOR

Basal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime.

Drug: Glargine

NPH insulin

ACTIVE COMPARATOR

Basal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime.

Drug: NPH

Interventions

Glargine DRUG

Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.

Also known as: Lantus

glargine insulin

NPH DRUG

NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.

Also known as: Novolin N, Humulin N

NPH insulin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ages18-75 admitted to a general medicine or surgical Department of Medicine hospitalist services.
• A known history of T2DM, receiving either diet alone, low dose insulin (≤0.4 units/kg/day), OADs, GLP1 analogs, or in any combination of OADs, GLP1 analogs and low dose insulin (≤0.4 units/kg/day).
• Subjects must have a BG \>140 mg/dL and ≤240 mg/dL before randomization without laboratory evidence of diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome (bicarbonate \<18 mEq/L, pH \<7.30, or positive serum or urinary ketones, BG \>240 mg/dL).

You may not qualify if:

• Patients with a diagnosis of type 1 diabetes mellitus.
• Patients using nutritional bolus insulin at home.
• Patients with increased blood glucose concentration, but without a known history of diabetes.
• Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
• Patients admitted to or expected to require admission to any intensive care unit (ICU) or intermediate care unit (IMC).
• Patients who are receiving or are anticipated to receive enteral or parenteral nutrition.
• Patients admitted for cardiac surgery.
• Patients receiving continuous insulin infusion.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dL).
• Persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).
• Female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Diabetes Mellitus; Hypoglycemia

Interventions

Insulin Glargine; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stephen C Clement, MD

  Inova Fairfax Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

US (1)