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Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

NCT00653302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2008-12-03

No results posted yet for this study

Summary

Primary objective:

* Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c\<7% and/or a final decrease of HbA1c\>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

* Determination of the predictive criterion of HbA1c final,
* Determination of the predictive criterion of weight variation,
* Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
* Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

* Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Conditions

Interventions

DRUG

Lantus (insulin glargine) + Glucophage (Metformin)

Sponsors & Collaborators

Principal Investigators

  • Nathalie Billon · Sanofi-aventis administrative office France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-09-30
Completion
2005-10-31

Countries

  • France

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653302 on ClinicalTrials.gov