Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial (VIRDICT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Cairo University.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Sanofi

Information provided by:

Cairo University

ClinicalTrials.gov Identifier:

NCT01143948

First received: June 10, 2010

Last updated: June 14, 2010

Last verified: February 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Liver Cirrhosis	Drug: Glargine & Glulisine Drug: Regular insulin Drug: NPH & regular insulin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:

optimal glycemic control in inpatient cirrhotics [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of hypoglycemic episodes [ Time Frame: 3-7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	January 2011
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 15 patient sliding scale regular insulin	Drug: Regular insulin Sliding scale regular insulin Other Name: actrapid
Active Comparator: 15 patient BBI NPH plus regular insulin	Drug: NPH & regular insulin Basal NPH & bolus regular insulin Other Name: mixtard
Active Comparator: 15 patients BBI Glargine plus Glulisine	Drug: Glargine & Glulisine Basal Glargine & bolus Glulisine Other Names: lantus apidra

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143948

Contacts

Contact: Mostafa M Alfishawy, MB BCh

0111183371

mostafa.alfishawy@yahoo.com

Locations

Egypt
Internal medicine hospital ,Cairo University	Active, not recruiting
Cairo, Egypt, 11956

Sponsors and Collaborators

Cairo University

Sanofi

Investigators

Study Chair:	Ibtisam Z Eissa, MD	Cairo University
Study Director:	Mary N Rizk, MD	Cairo Univerity
Study Director:	Ahmad A Khairy, MD	Cairo University

More Information

Publications:

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. No abstract available.

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.

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.

Responsible Party:	Internal Medicine Department, Cairo University
ClinicalTrials.gov Identifier:	NCT01143948 History of Changes
Other Study ID Numbers:	LC-T2D
Study First Received:	June 10, 2010
Last Updated:	June 14, 2010
Health Authority:	Egypt: Institutional Review Board

Keywords provided by Cairo University:

Diabetes
Cirrhosis
Insulin
Inpatient

Additional relevant MeSH terms:

Insulin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Liver Cirrhosis
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Liver Diseases
Digestive System Diseases
Pathologic Processes
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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