| Trial ID: | L6421 |
| Source ID: | NCT00979628
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| Associated Drug: |
Sliding Scale Regular Insulin (Ssri)
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| Title: |
Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
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| Acronym: |
Basal-Plus
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00979628/results
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| Conditions: |
Type 2 Diabetes|Hyperglycemia
|
| Interventions: |
DRUG: sliding scale regular insulin (SSRI)|DRUG: Basal Bolus|DRUG: Basal Plus
|
| Outcome Measures: |
Primary: 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, 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)., Randomization and 24 hrs after treatment | Secondary: 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, 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., During hospital stay, up to 12 days
|
| Sponsor/Collaborators: |
Sponsor: Guillermo Umpierrez, MD | Collaborators: Sanofi|Medical University of South Carolina|Texas A&M University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
375
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2010-01
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| Completion Date: |
2012-06
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| Results First Posted: |
2014-04-24
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| Last Update Posted: |
2018-10-10
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| Locations: |
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States|Atlanta VA Medical Center, Decatur, Georgia, 30030, United States|Medical University of South Carolina, Charleston, South Carolina, 29425-6240, United States|Scott & White Memorial Hospital and Clinic, Temple, Texas, 76508, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00979628
|
