Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

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

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
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


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

Inclusion Criteria:

  • Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00513201

Department of Medicine
Naples, Italy, 80131
Sponsors and Collaborators
Second University of Naples
Study Chair: Roberto Torella, MD Second University of Naples
  More Information

No publications provided 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:
regular insulin
cirrhotic patients

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 20, 2014