Clinical trial NCT01855243: Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus (DM)
Keywords: Type 2 D M
sliding scale insulin
70/30 insulin
basals insulin
supplemental insulin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.
timeFrame: during hospital stay which is expected to be average 3 weeks
measure: Mean BG After First Day of Hospitalization
timeFrame: after first day of hospitalization
Secondary outcomes:
measure: Number of Patients Developed Hypoglycemic Events
timeFrame: during hospital stay which is expected to be average 3 weeks
measure: Number of Patients Developed Episodes of Severe Hyperglycemia
timeFrame: during hospital stay which is expected to be average 3 weeks
measure: Mortality Rate
timeFrame: during the hospital stay which is expected to be average 3 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: the department of internal medicine, Cairo University teaching hospitals,
Study officials:
References:
citation: Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
citation: Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.