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

NCT00732524 | Completed Phase 4 DMC

• 1 other identifier: IRB #04-128
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Hyperglycemia; Glucose toxicity; Glargine; Glipizide

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.

  2 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Glipizide arm

ACTIVE COMPARATOR

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

Glipizide + Glargine

ACTIVE COMPARATOR

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

Interventions

Glipizide DRUG

Glipizide XL 10 mg once daily 30 mins before breakfast

Also known as: Glucotrol XL

Glipizide arm

Glipizide and Glargine DRUG

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

Also known as: Insulin Lantus

Glipizide + Glargine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H Stroger Hospital Of Cook County

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• 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.

  PMID: 1441492 BACKGROUND

• 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.

  PMID: 11052953 BACKGROUND

• 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.

  PMID: 8675555 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Glipizide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Sulfones; Sulfur Compounds; Organic Chemicals; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Leon A Fogelfeld, MD

  John H Stroger Hospital Of Cook County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: September 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

US (1)