NCT00732524

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

Combination of Sulfonylureas and Insulin Glargine as Safety Net Outpatient Therapy for Unstable Diabetes and Impending Diabetic Ketoacidosis (DKA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cook County Health · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Glipizide	Glipizide XL 10 mg once daily 30 mins before breakfast
DRUG	Glipizide and Glargine	Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2008-08-12
• Last updated: 2008-08-12

Locations

1 site across 1 country: United States