Overview

This trial is active, not recruiting.

Condition diabetes mellitus (dm)
Treatments regular insulin, 70/30 insulin, glargine, glulisine
Sponsor Cairo University
Start date March 2010
End date February 2014
Trial size 65 participants
Trial identifier NCT01855243, CairoU teaching hospital

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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 lantus
glulisine apidra
(Active Comparator)
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.
regular insulin
70/30 insulin
(Active Comparator)
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
regular insulin

Primary Outcomes

Measure
differences in glycemic control between treatment groups as measured by mean daily BG concentration during their hospital stay.
time frame: during hospital stay which is expected to be average 3 weeks

Secondary Outcomes

Measure
number of hypoglycemic events
time frame: during hospital stay which is expected to be average 3 weeks
number of episodes of severe hyperglycemia
time frame: during hospital stay which is expected to be average 3 weeks
mortality rate
time frame: during the hospital stay which is expected to be average 3 weeks

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Cairo University.