Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM
Not Applicable
Completed
- Conditions
- Diabetes Mellitus (DM)
- Interventions
- Registration Number
- NCT01855243
- Lead Sponsor
- Cairo University
- Brief Summary
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.
Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- known history of type 2 DM for longer than 3 months
- age between 18-64 year old,
- treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.
Exclusion Criteria
- subjects with hyperglycemia without any known history of DM
- presence of diabetic ketoacidosis (DKA)
- patients admitted to intensive care unit (ICU)
- subjects expected to undergo surgery during the hospitalization course
- patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 70/30 insulin plus supplemental lunch insulin regular insulin Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. 70/30 insulin plus supplemental lunch insulin 70/30 insulin Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. Sliding Scale insulin (SSI) regular insulin For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table glargine plus supplemental glulisine glulisine Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. glargine plus supplemental glulisine Glargine Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.
- Primary Outcome Measures
Name Time Method Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. during hospital stay which is expected to be average 3 weeks Mean BG After First Day of Hospitalization after first day of hospitalization
- Secondary Outcome Measures
Name Time Method Mortality Rate during the hospital stay which is expected to be average 3 weeks Number of Patients Developed Hypoglycemic Events during hospital stay which is expected to be average 3 weeks Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events.
Number of Patients Developed Episodes of Severe Hyperglycemia during hospital stay which is expected to be average 3 weeks Hyperglycemic events are defined as BG \> 300 mg/dL.
Trial Locations
- Locations (1)
the department of internal medicine, Cairo University teaching hospitals,
🇪🇬Cairo, Egypt