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