Clinical trial NCT00732524: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Hyperglycemia
Glucose toxicity
Glargine
Glipizide
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2008-08-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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

Primary outcomes:
measure: The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.
timeFrame: 2 months
Secondary outcomes:
measure: 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.
timeFrame: 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Hospital Of Cook County
state: Illinois
Study officials:
affiliation: John H Stroger Hospital Of Cook County
name: Leon A Fogelfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
citation: 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. doi: 10.1152/ajpendo.2000.279.5.E997.
citation: 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. doi: 10.1210/jcem.81.7.8675555.