Completed

Basal-PlusBasal Bolus vs Basal Insulin Regimen for Hospitalized Type 2 Diabetes Patients' Glucose Control

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Study Aim

This study aims to compare the effectiveness of three different insulin regimens - Basal Plus, Basal Bolus, and Sliding Scale Regular Insulin (SSRI) - in controlling blood glucose levels in hospitalized patients with Type 2 Diabetes, with the goal of achieving optimal glycemic control (blood glucose levels between 70 mg/dL -140 mg/dL).

What is being tested

sliding scale regular insulin (SSRI)

+ Basal Bolus

+ Basal Plus

Drug
Who is being recruted

Diabetes Mellitus+4

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorGuillermo Umpierrez, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleBasal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus
NCT00979628
Principal SponsorGuillermo Umpierrez, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

375 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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).
9 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
sliding scale regular insulin subcutaneously four-times daily in patients with T2DM admitted to general medicine and surgery wards.

Group II

Experimental
glargine subcutaneously once daily plus glulisine subcutaneously before meals (plus corrective doses of glulisine as needed)

Group III

Experimental
glargine subcutaneously once daily plus corrective doses of glulisine subcutaneously before meals and bedtime as needed

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Grady Memorial Hospital

Atlanta, United StatesOpen Grady Memorial Hospital in Google Maps
Suspended

Emory University Hospital

Atlanta, United States
Suspended

Atlanta VA Medical Center

Decatur, United States
Suspended

Medical University of South Carolina

Charleston, United States
Completed5 Study Centers