Lyspro Insulin vs Regular Insulin in Cirrhotic Patients
Information source: Second University of Naples
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Cirrhosis
Intervention: lyspro (Drug); regular insulin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Second University of Naples Official(s) and/or principal investigator(s):
Roberto Torella, MD, Study Chair, Affiliation: Second University of Naples
Summary
OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients
with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver
cirrhosis and type 2 diabetes were randomly treated with regular insulin or lispro. After
122 weeks a cross-over was carried out and patients followed-up for 122 weeks. Then, all
patients received a standard breakfast of 145 kcal following 12 U. I. of regular insulin or
lispro, and C-peptide and insulin serum levels were determined over 300 minutes.
Clinical Details
Study design: Randomized, Double-Blind, Crossover Assignment
Primary outcome: Glycemic control in lyspro vs regular insulin treated patientsGlycemic control in lyspro vs regular insulin treated patients Glycemic control in lyspro vs regular insulin in cirrhotic patients
Secondary outcome: Tolerance to treatment and reduced postprandial hypoglycemia episodes
Eligibility
Minimum age: 48 Years.
Maximum age: 67 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Insulin-treated diabetes mellitus and liver cirrhosis
Exclusion Criteria:
- Oral hypoglycemic agents treated diabetes mellitus
- Liver cancer
Locations and Contacts
Department of Medicine, Naples 80131, Italy
Additional Information
Last updated: August 7, 2007
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