Overview

Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin

Status:
Withdrawn
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose <110 mg/dl) versus conservative (goal pre-prandial blood glucose <180mg/dl) diabetes treatment of type 2 diabetic patients on the general medical wards has any effect on hospital outcomes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin Detemir
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Existing diagnosis of type 2 diabetes.

- Admitted to a non-telemetry, non-ICU medicine inpatient bed.

- Willing and able to give informed consent.

- HgbA1c of any value will be accepted.

Exclusion Criteria:

- Type 1 diabetes

- Admitted to a telemetry, ICU, or non-medicine inpatient bed (e.g., surgery,
neurosurgery, obstetrics/gynecology, psychiatry).

- Diabetic ketoacidosis (arterial ph <7.24, serum bicarbonate <15, positive serum
ketones, anion gap >12)

- Hyperosmolar hyperglycemic state (blood glucose >200 mg/dl, serum osmolarity >320
mOsm/kg)

- Inability to cooperate with study personnel.

- Known allergy or intolerance to detemir or novolog.

- Admission to the hospital >24 hours from entry into the study.

- Admission to the hospital for inpatient hospice care.

- Admission/continued admission to the hospital for procurement of a guardian.

- Admission/continued admission to the hospital for rehabilitation.

- Patients admitted with the diagnosis of acute coronary syndrome.

- Patients admitted with the diagnosis of acute cerebrovascular accident.

- Patients currently pregnant or breast-feeding.

- Patients not fluent in English or Spanish as it will be difficult to obtained written
informed consent in another language.