Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM) (Basal-Plus)

• ClinicalTrials.gov Identifier: NCT00979628
• Recruitment Status: Completed
• First Posted: September 18, 2009
• Results First Posted: April 24, 2014
• Last Update Posted: October 10, 2018
• Sponsor: Guillermo Umpierrez, MD
• Collaborators: Sanofi; Medical University of South Carolina; Texas A&M University
• Information provided by (Responsible Party): Guillermo Umpierrez, MD, Emory University

Study Description

Brief Summary:

The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Hyperglycemia	Drug: sliding scale regular insulin (SSRI); Drug: Basal Bolus; Drug: Basal Plus	Phase 4

Detailed Description:

High blood glucose levels in medical and surgery patients with diabetes are associated with increased risk of in-hospital complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Numerous studies have shown that high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). The investigators' recent preliminary data also indicate that a single daily dose of glargine plus corrective doses of glulisine before meals if needed (Basal Plus) is effective in the management of medical and surgical patients with type 2 diabetes mellitus (T2DM). The average daily blood glucose (BG) levels in patients treated with Basal Plus is equivalent to levels in patients treated with Basal Bolus with glargine once daily plus glulisine before meals (basal bolus regimen). The mean daily BG levels in patients treated with basal plus are lower than those reported in patients treated with sliding scale regular insulin (SSRI). Accordingly, the present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes admitted to general medicine wards. Glargine, glulisine, and regular insulins are approved for use in the treatment of patients with diabetes by the FDA. A total of 375 subjects with type 2 diabetes will be recruited in this study. The sites for this study are Grady Memorial Hospital, Emory University Hospital, the Atlanta VA Medical Center, Scott & White Memorial Hospital and Clinic, and Medical University of South Carolina.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus
• Study Start Date: January 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Basal Plus Regimen; glargine subcutaneously once daily plus corrective doses of glulisine subcutaneously before meals and bedtime as needed	Drug: Basal Plus; glargine once daily plus corrective doses of glulisine before meals and bedtime as needed; Other Names: Lantus (insulin glargine); Apidra (insulin glulisine)
Experimental: Basal Bolus; glargine subcutaneously once daily plus glulisine subcutaneously before meals (plus corrective doses of glulisine as needed)	Drug: Basal Bolus; glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed); Other Names: Lantus (insulin glargine); Apidra (insulin glulisine)
Active Comparator: sliding scale regular insulin (SSRI); sliding scale regular insulin subcutaneously four-times daily in patients with T2DM admitted to general medicine and surgery wards.	Drug: sliding scale regular insulin (SSRI); four-time daily in patients with T2DM admitted to general medicine and surgery wards.; Other Name: Novolin R

Outcome Measures

Primary Outcome Measures :

1. Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments [ Time Frame: Randomization and 24 hrs after treatment ]
   The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions).

Secondary Outcome Measures :

1. Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments [ Time Frame: During hospital stay, up to 12 days ]
   Effective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels <70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males or females between the ages of 18 and 75 years admitted to a general medicine or surgical services.
• A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas, meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV inhibitors).
• Patients admitted for non-cardiac elective or emergency surgery or trauma.
• Subjects must have an admission BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent /L, potential hydrogen (pH) < 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

• Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
• Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [32].
• Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
• Patients admitted for coronary artery bypass graft (CABG) or patients receiving continuous insulin infusion.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.0 mg/dl).
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.

Contacts and Locations

Locations

United States, Georgia

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Emory University Hospital

Atlanta, Georgia, United States, 30322

Atlanta VA Medical Center

Decatur, Georgia, United States, 30030

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425-6240

United States, Texas

Scott & White Memorial Hospital and Clinic

Temple, Texas, United States, 76508

Sponsors and Collaborators

Guillermo Umpierrez, MD

Sanofi

Medical University of South Carolina

Texas A&M University

Investigators

• Principal Investigator: Guillermo Umpierrez, MD; Emory SOM

More Information

Publications of Results:

Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Umpierrez GE, Reyes D, Smiley D, Hermayer K, Khan A, Olson DE, Pasquel F, Jacobs S, Newton C, Peng L, Fonseca V. Hospital discharge algorithm based on admission HbA1c for the management of patients with type 2 diabetes. Diabetes Care. 2014 Nov;37(11):2934-9. doi: 10.2337/dc14-0479. Epub 2014 Aug 28.

• Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
• ClinicalTrials.gov Identifier: NCT00979628
• Other Study ID Numbers: IRB00020328a
• First Posted: September 18, 2009
• Results First Posted: April 24, 2014
• Last Update Posted: October 10, 2018
• Last Verified: September 2018

Keywords provided by Guillermo Umpierrez, MD, Emory University:

Type 2 Diabetes; Inpatient Hyperglycemia

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine; Hypoglycemic Agents; Physiological Effects of Drugs