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

Primary Purpose

Type 2 Diabetes, Liver Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Glargine & Glulisine
Regular insulin
NPH & regular insulin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Cirrhosis, Insulin, Inpatient

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Internal medicine hospital ,Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

15 patient sliding scale regular insulin

15 patient BBI NPH plus regular insulin

15 patients BBI Glargine plus Glulisine

Arm Description

Outcomes

Primary Outcome Measures

optimal glycemic control in inpatient cirrhotics

Secondary Outcome Measures

Incidence of hypoglycemic episodes

Full Information

First Posted
June 10, 2010
Last Updated
June 14, 2010
Sponsor
Cairo University
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01143948
Brief Title
Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial
Acronym
VIRDICT
Official Title
Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cairo University
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Liver Cirrhosis
Keywords
Diabetes, Cirrhosis, Insulin, Inpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
15 patient sliding scale regular insulin
Arm Type
Active Comparator
Arm Title
15 patient BBI NPH plus regular insulin
Arm Type
Active Comparator
Arm Title
15 patients BBI Glargine plus Glulisine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Glargine & Glulisine
Other Intervention Name(s)
lantus, apidra
Intervention Description
Basal Glargine & bolus Glulisine
Intervention Type
Drug
Intervention Name(s)
Regular insulin
Other Intervention Name(s)
actrapid
Intervention Description
Sliding scale regular insulin
Intervention Type
Drug
Intervention Name(s)
NPH & regular insulin
Other Intervention Name(s)
mixtard
Intervention Description
Basal NPH & bolus regular insulin
Primary Outcome Measure Information:
Title
optimal glycemic control in inpatient cirrhotics
Time Frame
3-7 days
Secondary Outcome Measure Information:
Title
Incidence of hypoglycemic episodes
Time Frame
3-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa M Alfishawy, MB BCh
Phone
0111183371
Email
mostafa.alfishawy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibtisam Z Eissa, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mary N Rizk, MD
Organizational Affiliation
Cairo Univerity
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmad A Khairy, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Internal medicine hospital ,Cairo University
City
Cairo
ZIP/Postal Code
11956
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
2037851
Citation
Balkau B, Eschwege E, Ducimetiere 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. doi: 10.1016/0895-4356(91)90209-r.
Results Reference
background
PubMed Identifier
10332677
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. doi: 10.2337/diacare.22.5.756.
Results Reference
background
PubMed Identifier
17327353
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. doi: 10.2337/dc06-1539. No abstract available.
Results Reference
result

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Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

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