Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

This study has been completed.

First Received: August 7, 2007 No Changes Posted

Sponsor:	Second University of Naples
Information provided by:	Second University of Naples
ClinicalTrials.gov Identifier:	NCT00513201

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Cirrhosis	Drug: lyspro Drug: regular insulin	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Diabetes

Drug Information available for: Insulin Insulin lispro

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Tolerance to treatment and reduced postprandial hypoglycemia episodes

Eligibility

Ages Eligible for Study:	48 Years to 67 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

Oral hypoglycemic agents treated diabetes mellitus
Liver cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513201

Locations

Italy
Department of Medicine
Naples, Italy, 80131

Sponsors and Collaborators

Second University of Naples

Investigators

Study Chair:

Roberto Torella, MD

Second University of Naples

More Information

No publications provided

Study ID Numbers:	Second University of Naples
Study First Received:	August 7, 2007
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00513201 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Second University of Naples:

lyspro
regular insulin
lyspro
cirrhotic patients

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Metabolic Diseases
Fibrosis
Physiological Effects of Drugs
Diabetes Mellitus

Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 11, 2009