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Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (DM) (Basal Plus)
This study has been completed.
Sponsor:
Guillermo Umpierrez
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
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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 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 Guillermo Umpierrez, 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 ]
Secondary Outcome Measures:
- To Determine Differences Between Treatments Arms in # of Hypoglycemic Events [ Time Frame: during hospitalization ]
| 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:
|
|
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:
|
|
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 (Adult, Senior) |
| 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, 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00979628
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Guillermo Umpierrez, 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, Globin Zinc Insulin glulisine Insulin Insulin Glargine Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 19, 2017