NCT00576368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,464

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_4 diabetes-mellitus

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

Study Start

First participant enrolled

June 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
Last Updated

January 9, 2008

Status Verified

December 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 28, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice)

    at least 3months

Study Arms (1)

1

EXPERIMENTAL
Drug: INSULIN GLARGINE

Interventions

INSULIN GLARGINEDRUG

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Brussels, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • E Hens

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

June 1, 2003

Study Completion

April 1, 2004

Last Updated

January 9, 2008

Record last verified: 2007-12

Locations

BE(1)