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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Medical University of South Carolina
Texas A&M University
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00979628
First received: September 16, 2009
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Hyperglycemia
Drug: sliding scale regular insulin (SSRI)
Drug: Basal Bolus
Drug: Basal Plus
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: Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus: a Randomized, Open Labeled, Non-inferiority Controlled Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • To Determine Glycemic Control Between Basal Plus(Glargine Once Daily Plus Corrective Doses of Glulisine Before Meals and Bedtime as Needed), Basal Bolus Approach of Glargine Once Daily Plus Glulisine Before Meals and SSRI [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To Determine Differences Between Treatments Arms in # of Hypoglycemic Events [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 375
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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, 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 mEq/L, 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 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
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: NCT00979628

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
Sanofi
Medical University of South Carolina
Texas A&M University
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory SOM
  More Information

Publications:
Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00979628     History of Changes
Other Study ID Numbers: IRB00020328a
Study First Received: September 16, 2009
Results First Received: March 24, 2014
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Glargine
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014