Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

Phase 4

• Conditions: Type 2 Diabetes; Liver Cirrhosis
• Interventions: Drug: Regular insulin; Drug: NPH & regular insulin; Drug: Glargine & Glulisine

• Registration Number: NCT01143948
• Lead Sponsor: Cairo University

Brief Summary

Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis \& type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.

Detailed Description

Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH \& regular insulin or Glargine \& Glulisine.

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-14
• Last Update Submitted: 2010-06-14
• Study First Posted: 2010-06-15
• Last Update Posted: 2010-06-15
• Study Start: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
• Entry blood glucose (fasting or random) greater than 180 mg%

Exclusion Criteria

• Type 1 Diabetes Mellitus
• Pregnancy
• Steroids: prednisone greater than 7.5mg/day or equivalent
• Serum Creatinine > 3 mg/dl
• Patients in intensive care units.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 patient sliding scale regular insulin	Regular insulin	-
15 patient BBI NPH plus regular insulin	NPH & regular insulin	-
15 patients BBI Glargine plus Glulisine	Glargine & Glulisine	-

Primary Outcome Measures

Name	Time	Method
optimal glycemic control in inpatient cirrhotics	3-7 days

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemic episodes	3-7 days

Trial Locations

Locations (1)

Internal medicine hospital ,Cairo University; 🇪🇬 Cairo, Egypt