Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

Type 2 Diabetes Clinical Trial

— VIRDICT  

Official title:

Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01143948
• Other study ID #: LC-T2D
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 10, 2010
• Last updated: June 14, 2010
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: February 2010
• Source: Cairo University
• Contact: Mostafa M Alfishawy, MB BCh
• Phone: 0111183371
• Email: mostafa.alfishawy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Liver Cirrhosis
• Type 2 Diabetes

Intervention

Drug:
• Glargine & Glulisine
Basal Glargine & bolus Glulisine
• Regular insulin
Sliding scale regular insulin
• NPH & regular insulin
Basal NPH & bolus regular insulin

Locations

Country	Name	City	State
Egypt	Internal medicine hospital ,Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Sanofi

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Balkau B, Eschwège E, Ducimetière P, Richard JL, Warnet JM. The high risk of death by alcohol related diseases in subjects diagnosed as diabetic and impaired glucose tolerant: the Paris Prospective Study after 15 years of follow-up. J Clin Epidemiol. 1991;44(6):465-74. — View Citation

de Marco R, Locatelli F, Zoppini G, Verlato G, Bonora E, Muggeo M. Cause-specific mortality in type 2 diabetes. The Verona Diabetes Study. Diabetes Care. 1999 May;22(5):756-61. — View Citation

Tolman KG, Fonseca V, Dalpiaz A, Tan MH. Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care. 2007 Mar;30(3):734-43. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optimal glycemic control in inpatient cirrhotics		3-7 days	No
Secondary	Incidence of hypoglycemic episodes		3-7 days	Yes