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

Type 2 Diabetes Clinical Trial

Official title:

Combination of Sulfonylureas and Insulin Glargine as Safety Net Outpatient Therapy for Unstable Diabetes and Impending Diabetic Ketoacidosis (DKA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732524
• Other study ID #: IRB #04-128
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2008
• Last updated: August 11, 2008
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: August 2008
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Drug:
• Glipizide
Glipizide XL 10 mg once daily 30 mins before breakfast
• Glipizide and Glargine
Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily

Locations

Country	Name	City	State
United States	John H Stroger Hospital Of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
John H. Stroger Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.		2 months
Secondary	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