Lyspro Insulin vs Regular Insulin in Cirrhotic Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

August 7, 2007

Last Updated Date

August 7, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Glycemic control in lyspro vs regular insulin treated patients
Glycemic control in lyspro vs regular insulin in cirrhotic patients

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Tolerance to treatment and reduced postprandial hypoglycemia episodes

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

Official Title ^ICMJE

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Crossover Assignment

Condition ^ICMJE

Diabetes Mellitus
Cirrhosis

Intervention ^ICMJE

Drug: lyspro
Drug: regular insulin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

Oral hypoglycemic agents treated diabetes mellitus
Liver cancer

Gender

Both

Ages

48 Years to 67 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00513201

Responsible Party

Study ID Numbers ^ICMJE

Second University of Naples

Study Sponsor ^ICMJE

Second University of Naples

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Roberto Torella, MD

Second University of Naples

Information Provided By

Second University of Naples

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP