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OpenTrials
Completed

NCT Number: NCT00513201

Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

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.

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Key information

Conditions

Diabetes Mellitus Cirrhosis Endocrine System Diseases Fibrosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

48 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine

Naples, 80131, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion criteria

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer

Treatment and study plan

lyspro

Drug

Regular insulin

Drug

Primary outcomes

  1. Glycemic control in lyspro vs regular insulin treated patients

  2. Glycemic control in lyspro vs regular insulin in cirrhotic patients

Secondary outcomes

  1. Tolerance to treatment and reduced postprandial hypoglycemia episodes

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Important dates

First posted
Aug 8, 2007
Registry last updated
Aug 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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