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Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00513201
First Posted: August 8, 2007
Last Update Posted: August 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campania "Luigi Vanvitelli"
  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

Resource links provided by NLM:


Further study details as provided by University of Campania "Luigi Vanvitelli":

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

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513201


Locations
Italy
Department of Medicine
Naples, Italy, 80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Study Chair: Roberto Torella, MD University of Campania "Luigi Vanvitelli"
  More Information

ClinicalTrials.gov Identifier: NCT00513201     History of Changes
Other Study ID Numbers: Second University of Naples
First Submitted: August 7, 2007
First Posted: August 8, 2007
Last Update Posted: August 8, 2007
Last Verified: August 2007

Keywords provided by University of Campania "Luigi Vanvitelli":
lyspro
regular insulin
cirrhotic patients

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs