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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   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer
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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 Identifier: NCT00513201     History of Changes
Other Study ID Numbers: Second University of Naples
Study First Received: August 7, 2007
Last Updated: August 7, 2007

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 25, 2017