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

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

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.

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).

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Glipizide arm
  • 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
• Active Comparator: Glipizide + 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

Primary Measures

• The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.
  • Time Frame: 2 months
    Safety Issue?: Yes

Secondary Measures

• 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.
  • Time Frame: 2 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: John H. Stroger Hospital Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00732524

Study ID Number: IRB #04-128

ClinicalTrials.gov Identifier: NCT00732524

Health Authority: United States: Institutional Review Board