The Inova Type 2 Diabetes Mellitus Study
The Inova Type 2 Diabetes Mellitus Study
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.
This is a randomized, open label trial comparing effectiveness of insulin glargine and
 insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an
 intervention (NPH) or a control group (glargine) upon admission. The following data will be
 collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C,
 blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of
 hospitalization, insulin dose, and discharge status. Data will be recorded and maintained
 confidentially.
Inclusion Criteria:

 1. Adult patients ages18-75 admitted to a general medicine or surgical Department of
 Medicine hospitalist services.

 2. 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).

 3. 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).

 Exclusion Criteria:

 1. Patients with a diagnosis of type 1 diabetes mellitus.

 2. Patients using nutritional bolus insulin at home.

 3. Patients with increased blood glucose concentration, but without a known history of
 diabetes.

 4. Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar
 nonketotic syndrome, or ketonuria.

 5. Patients admitted to or expected to require admission to any intensive care unit (ICU)
 or intermediate care unit (IMC).

 6. Patients who are receiving or are anticipated to receive enteral or parenteral
 nutrition.

 7. Patients admitted for cardiac surgery.

 8. Patients receiving continuous insulin infusion.

 9. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
 portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥
 3.5 mg/dL).

 10. Persons with decisional incapacity (mental condition rendering the subject unable to
 understand the nature, scope, and possible consequences of the study).

 11. Female subjects who are pregnant or immediately (same hospitalization) post partum at
 time of enrollment into the study.

 12. Patients with recognized or suspected endocrine disorders associated with increased
 insulin resistance, acromegaly, or hyperthyroidism.