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

Completed · Phase 4

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00732524

Run by

Cook County Health

People needed

80

Starts

2004-09-01

Expected to finish

2006-04-01

Last updated by the study team

2008-08-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• John H Stroger Hospital Of Cook County — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.