Expired Study
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Chicago, Illinois 60612


Purpose:

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.


Study summary:

This study is an open label randomized controlled trial in adult DM2 patients seen in ED services at John H. Stroger Hospital of Cook County serving a largely uninsured/underserved population. 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. Subjects were randomized to one of the two fixed dose treatment groups: 1) Glipizide XL 10 mg orally daily prior to breakfast (G group), 2) Glipizide XL 10 mg orally daily along with Insulin Glargine 10 units at bedtime, subcutaneously (G+G group).


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


NCT ID:

NCT00732524


Primary Contact:

Principal Investigator
Leon A Fogelfeld, MD
John H Stroger Hospital Of Cook County


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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