Overview

Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare two simple and safe emergency department discharge therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for inpatient admission.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
John H. Stroger Hospital
Treatments:
Glipizide
Insulin
Insulin Glargine
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Individuals more than 18 years of age with DM2, either with new onset DM2 or known
diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting
with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700
mg/dl and who did not have any exclusion criteria listed in Table 1, were eligible for
the study.

Exclusion Criteria:

- Acute metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia
associated with dehydration).

- Acute complications of chronic cardiovascular, neurological, renal, and other diabetic
complications.

- Any subject with unstable vitals signs (temperature > 101 degrees F, systolic blood
pressure < 90 or > 180 mm hg, diastolic blood pressure < 60 or > 110 mm hg, heart rate
< 60 or > 120 beats/minute).

- Electrolyte imbalances (serum bicarbonate level < 20 mEq/L, serum sodium < 125 & > 150
mEq/L, serum potassium < 3.5 & > 5.5 mEq/L).

- Evidence of an impaired sensorium and/or dementia.

- Age > 75 years

- Subjects with any acute medical illness.

- Type 1 diabetes or type 2 diabetics weighing less than 120 lbs

- Current addiction to illicit substances or alcohol abuse

- Pregnant or lactating subjects