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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Glipizide
* Drug: Glipizide and Glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glipizide arm<br>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 | Drug: Glipizide<br>* Glipizide XL 10 mg once daily 30 mins before breakfast<br>* Other names: Glucotrol XL;|
| Active Comparator: Glipizide + Glargine<br>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 | Drug: Glipizide and Glargine<br>* Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily<br>* Other names: Insulin Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperglycemia, Glucose toxicity, Glargine, Glipizide