Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Study Overview
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Brief Summary
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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.

Official Title
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Premix 70/30 Insulin Plus Supplemental Lunch Insulin in Comparison to Basal Plus Prandial Supplemental Scale and Sliding Scale Insulin in Hospitalized Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus (DM)

Intervention / Treatment
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* Drug: regular insulin
* Drug: 70/30 insulin
* Drug: Glargine
* Drug: glulisine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glargine plus supplemental glulisine<br>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. | Drug: Glargine<br> <br> * Other names: lantus;Drug: glulisine<br> <br> * Other names: apidra;|
| Active Comparator: 70/30 insulin plus supplemental lunch insulin<br>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. | Drug: regular insulin<br> <br> Drug: 70/30 insulin<br> <br> |
| Active Comparator: Sliding Scale insulin (SSI)<br>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 | Drug: regular insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Developed Hypoglycemic Events | 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. | during hospital stay which is expected to be average 3 weeks | 
| Number of Patients Developed Episodes of Severe Hyperglycemia | Hyperglycemic events are defined as BG > 300 mg/dL. | during hospital stay which is expected to be average 3 weeks | 
| Mortality Rate |  | during the hospital stay which is expected to be average 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 D M, sliding scale insulin, 70/30 insulin, basals insulin, supplemental insulin