A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

NCT ID: NCT00468754

Last Updated: 2016-03-03

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-05-31

Brief Summary

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This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Insulin pumps

Intervention Type DEVICE

B

Group Type EXPERIMENTAL

Insulin pumps

Intervention Type DEVICE

Interventions

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Insulin pumps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetic patients, 18-60 years of age
* Diabetic for \>2 years
* Treated with CSII for \>=6 months
* HbA1c \<8.5%

Exclusion Criteria

* Treatment with daily insulin injections
* Inability to handle pump therapy
* Untreated retinopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Buhr

Role: STUDY_DIRECTOR

Disetronic Medical Systems AG

Locations

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Bergamo, , Italy

Site Status

Brescia, , Italy

Site Status

Padua, , Italy

Site Status

Pisa, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RD000000275

Identifier Type: -

Identifier Source: secondary_id

RD000275

Identifier Type: -

Identifier Source: org_study_id

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