Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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lyspro

Intervention Type DRUG

regular insulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria

* Oral hypoglycemic agents treated diabetes mellitus
* Liver cancer

Minimum Eligible Age

48 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roberto Torella, MD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

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Department of Medicine

Naples, Naples, Italy

Site Status

Countries

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Italy

Other Identifiers

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Second University of Naples

Identifier Type: -

Identifier Source: org_study_id