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

Diabetes Mellitus (DM) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855243
• Other study ID #: CairoU teaching hospital
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: June 2014

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus (DM)

Intervention

Drug:
• regular insulin

• 70/30 insulin

• Glargine

• glulisine

Locations

Country	Name	City	State
Egypt	the department of internal medicine, Cairo University teaching hospitals,	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. Epub 2007 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.		during hospital stay which is expected to be average 3 weeks
Primary	Mean BG After First Day of Hospitalization		after first day of hospitalization
Secondary	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
Secondary	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
Secondary	Mortality Rate		during the hospital stay which is expected to be average 3 weeks