NCT00513201

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
Last Updated

August 8, 2007

Status Verified

August 1, 2007

First QC Date

August 7, 2007

Last Update Submit

August 7, 2007

Conditions

Diabetes MellitusCirrhosis

Keywords

lysproregular insulincirrhotic patients

Outcome Measures

Primary Outcomes (2)

  • Glycemic control in lyspro vs regular insulin treated patients

  • Glycemic control in lyspro vs regular insulin in cirrhotic patients

Secondary Outcomes (1)

  • Tolerance to treatment and reduced postprandial hypoglycemia episodes

Interventions

lysproDRUG
regular insulinDRUG

Eligibility Criteria

Age48 Years - 67 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insulin-treated diabetes mellitus and liver cirrhosis

You may not qualify if:

  • Oral hypoglycemic agents treated diabetes mellitus
  • Liver cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine

Naples, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Diabetes MellitusFibrosisInsulin Resistance

Interventions

Insulin LisproInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Roberto Torella, MD

    University of Campania Luigi Vanvitelli

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Last Updated

August 8, 2007

Record last verified: 2007-08

Locations

IT(1)