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

NCT ID: NCT00732524

Last Updated: 2008-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-04-30

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).

Conditions

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Type 2 Diabetes

Keywords

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Hyperglycemia Glucose toxicity Glargine Glipizide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Glipizide

Intervention Type DRUG

Glipizide XL 10 mg once daily 30 mins before breakfast

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

Group Type ACTIVE_COMPARATOR

Glipizide and Glargine

Intervention Type DRUG

Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily

Interventions

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Glipizide

Glipizide XL 10 mg once daily 30 mins before breakfast

Intervention Type DRUG

Glipizide and Glargine

Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily

Intervention Type DRUG

Other Intervention Names

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Glucotrol XL Insulin Lantus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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John H. Stroger Hospital

Principal Investigators

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Leon A Fogelfeld, MD

Role: PRINCIPAL_INVESTIGATOR

John H Stroger Hospital Of Cook County

Locations

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John H Stroger Hospital Of Cook County

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1441492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11052953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8675555 (View on PubMed)

Other Identifiers

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IRB #04-128

Identifier Type: -

Identifier Source: org_study_id