Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
- Registration Number
- NCT00732524
- Lead Sponsor
- Cook County Health
- 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 admission.
- 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. 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glipizide + Glargine Glipizide and Glargine Insulin Glargine is a recombinant human basal insulin analog. It was chosen since it is a non-peaking insulin with cover for 24 hours. It can be injected subcutaneously only once a day and has a low incidence of hypoglycemia Glipizide arm Glipizide Glipizide XL is an insulin secretagogue and is an extended release tablet designed to provide a controlled rate of delivery. Glipizide XL was chosen because it is the most frequently used discharge oral medication in our ED. It has a quick onset of action within a few hours after oral ingestion, lasts for 24 hours and has a powerful glucose lowering effect. In addition, there are very few contraindications to Glipizide XL and there is published literature regarding their use in subjects with severe hyperglycemia
- Primary Outcome Measures
Name Time Method The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens. 2 months
- Secondary Outcome Measures
Name Time Method The secondary outcomes included the number of subjects who reached a fasting or pre-meal BG goal of 80 to 130 mg/dl and assessment of the beta cell function at the beginning and end of the study as measured by C-peptide levels during OGTT testing. 2 months
Trial Locations
- Locations (1)
John H Stroger Hospital Of Cook County
🇺🇸Chicago, Illinois, United States