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NCT00513201 Clinical Trial

Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00513201
Other study ID # Second University of Naples
Secondary ID
Status Completed
Phase Phase 4
First received August 7, 2007
Last updated August 7, 2007

Study information
Verified date August 2007
Source Second University of Naples
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 48 Years to 67 Years
Eligibility Inclusion Criteria:

- Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

- Oral hypoglycemic agents treated diabetes mellitus

- Liver cancer

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• lyspro

• regular insulin

Locations
Country Name City State
Italy Department of Medicine Naples

Sponsors (1)
Lead Sponsor Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycemic control in lyspro vs regular insulin treated patients
Primary Glycemic control in lyspro vs regular insulin in cirrhotic patients
Secondary Tolerance to treatment and reduced postprandial hypoglycemia episodes
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