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

This study has been completed.
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00732524
First received: August 8, 2008
Last updated: August 11, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Glipizide
Drug: Glipizide and Glargine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of Sulfonylureas and Insulin Glargine as Safety Net Outpatient Therapy for Unstable Diabetes and Impending Diabetic Ketoacidosis (DKA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
 Drug: Glipizide
Glipizide XL 10 mg once daily 30 mins before breakfast
Other Name: Glucotrol XL
Active Comparator: 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
 Drug: Glipizide and Glargine
Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily
Other Name: Insulin Lantus

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732524

Locations
United States, Illinois
John H Stroger Hospital Of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Principal Investigator: Leon A Fogelfeld, MD John H Stroger Hospital Of Cook County
  More Information

Publications:

Responsible Party: Dr. Leon Fogelfeld, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00732524     History of Changes
Other Study ID Numbers: IRB #04-128
Study First Received: August 8, 2008
Last Updated: August 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Hyperglycemia
Glucose toxicity
Glargine
Glipizide

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ketosis
Acidosis
Acid-Base Imbalance
 Diabetes Complications
Autoimmune Diseases
Immune System Diseases
Glargine
Glipizide
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013