Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus; Cirrhosis

• Registration Number: NCT00513201
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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 122 weeks a cross-over was carried out and patients followed-up for 122 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Last Update Submitted: 2007-08-07
• Study First Posted: 2007-08-08
• Last Update Posted: 2007-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria

• Oral hypoglycemic agents treated diabetes mellitus
• Liver cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glycemic control in lyspro vs regular insulin treated patients
Glycemic control in lyspro vs regular insulin in cirrhotic patients

Secondary Outcome Measures

Name	Time	Method
Tolerance to treatment and reduced postprandial hypoglycemia episodes

Trial Locations

Locations (1)

Department of Medicine; 🇮🇹 Naples, Italy