Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/14/2017 |
| Start Date: | September 2004 |
| End Date: | April 2006 |
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.
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).
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).
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
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