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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: INSULIN GLARGINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576368

HOE901_5007

Details and patient eligibility

About

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.

Enrollment: 4,464 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,464 participants in 1 patient group

1

Experimental group

Treatment:

Drug: INSULIN GLARGINE