Trial record 10 of 894 for:    Open Studies | "Insulin"

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014