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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Liver Cirrhosis; Type 2 Diabetes

Treatments: Drug: NPH & regular insulin; Drug: Regular insulin; Drug: Glargine & Glulisine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01143948

LC-T2D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

15 patient sliding scale regular insulin

Active Comparator group

Treatment:

Drug: Regular insulin

15 patient BBI NPH plus regular insulin

Active Comparator group

Treatment:

Drug: NPH & regular insulin

15 patients BBI Glargine plus Glulisine

Active Comparator group

Treatment:

Drug: Glargine & Glulisine