Status:
COMPLETED
Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
Lead Sponsor:
Cook County Health
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 admissio...
Detailed Description
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. Individ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00732524
Start Date
September 1 2004
End Date
April 1 2006
Last Update
August 12 2008
Active Locations (1)
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1
John H Stroger Hospital Of Cook County
Chicago, Illinois, United States, 60612