Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00513201
First received: August 7, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind

Resource links provided by NLM:


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
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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

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

Keywords provided by Second University of Naples:
lyspro
regular insulin
cirrhotic patients

Additional relevant MeSH terms:
Diabetes Mellitus
Liver Cirrhosis
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014