An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice

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

Total Enrollment

4464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-04-30

Brief Summary

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The objective of this survey on this registered product is to confirm the efficacy, and safety profile of Lantus in every day medical practice. This program will also help to obtain information about the use of the insulin titration regimen and handling of the Lantus insulin analogue.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

INSULIN GLARGINE

Intervention Type DRUG

The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.

Interventions

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INSULIN GLARGINE

The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with Lantus, could enter in this program.