Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
Information source: John H. Stroger Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Glipizide (Drug); Glipizide and Glargine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: John H. Stroger Hospital Official(s) and/or principal investigator(s):
Leon A Fogelfeld, MD, Principal Investigator, Affiliation: John H Stroger Hospital Of Cook County
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.
Clinical Details
Official title: Combination of Sulfonylureas and Insulin Glargine as Safety Net Outpatient Therapy for Unstable Diabetes and Impending Diabetic Ketoacidosis (DKA)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.
Secondary outcome: 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.
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
John H Stroger Hospital Of Cook County, Chicago, Illinois 60612, United States
Additional Information
Related publications: Davidson MB. Successful treatment of markedly symptomatic patients with type II diabetes mellitus using high doses of sulfonylurea agents. West J Med. 1992 Aug;157(2):199-200. Gleason CE, Gonzalez M, Harmon JS, Robertson RP. Determinants of glucose toxicity and its reversibility in the pancreatic islet beta-cell line, HIT-T15. Am J Physiol Endocrinol Metab. 2000 Nov;279(5):E997-1002. Peters AL, Davidson MB. Maximal dose glyburide therapy in markedly symptomatic patients with type 2 diabetes: a new use for an old friend. J Clin Endocrinol Metab. 1996 Jul;81(7):2423-7.
Starting date: September 2004
Last updated: August 11, 2008
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