Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM) (Basal-Plus)
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ClinicalTrials.gov Identifier: NCT00979628 |
Recruitment Status :
Completed
First Posted : September 18, 2009
Results First Posted : April 24, 2014
Last Update Posted : October 10, 2018
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Hyperglycemia | Drug: sliding scale regular insulin (SSRI) Drug: Basal Bolus Drug: Basal Plus | Phase 4 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979628
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 |
Principal Investigator: | Guillermo Umpierrez, MD | Emory SOM |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Guillermo Umpierrez, MD, Professor of Medicine, Emory University |
ClinicalTrials.gov Identifier: | NCT00979628 |
Other Study ID Numbers: |
IRB00020328a |
First Posted: | September 18, 2009 Key Record Dates |
Results First Posted: | April 24, 2014 |
Last Update Posted: | October 10, 2018 |
Last Verified: | September 2018 |
Type 2 Diabetes Inpatient Hyperglycemia |
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 |