Atlanta, Georgia 30322


Purpose:

The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.


Study summary:

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.


Criteria:

Inclusion Criteria: 1. Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma 2. Known history of Type 2 diabetes mellitus for >3 months 3. Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy 4. Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis Exclusion Criteria: 1. Hyperglycemia without a history of diabetes 2. Subjects with acute critical illness admitted to the ICU or expected to require ICU admission 3. Subjects receiving continuous insulin infusion 4. Clinically relevant hepatic disease 5. Corticosteroid therapy 6. Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30 7. Subjects unable to sign consent 8. Pregnancy


NCT ID:

NCT02408120


Primary Contact:

Principal Investigator
Priyathama Vellanki, MD
Emory University

Priyathama Vellanki, MD
Phone: (404) 778 1687
Email: priyathama.vellanki@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States

Priyathama Vellanki, MD
Phone: 404-778-1687
Email: priyathama.vellanki@emory.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.