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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Ketoacidosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ketosis
Acidosis
Acid-Base Imbalance
Diabetes Complications
Insulin, Globin Zinc
Glargine
Glipizide
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014