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

December 2, 2008 updated by: Sanofi

Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Known type 2 diabetes for at least 2 years
  • No history of Ketoacidosis
  • BMI> 25 & <35 kg/m2

  • Type 2 diabetes treated with oral bi or tritherapy for at least 6 months

    • With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
    • and metformin at minimal posology 1700mg/day (1320 mg of metformin),
  • HbA1c >= 7.5 and <11% for 2 different dosages during the last year

Exclusion Criteria:

  • Type 1 diabetes
  • Glucophage intolerability
  • Pregnancy
  • Breast feeding
  • Partial pancreatectomy
  • Hypersensitivity to insulin glargine excipient
  • Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient
  • Hepatitis with transaminases >3ULN
  • Pre-proliferative or proliferative retinopathy
  • Acute cardiovascular accident within the last 6 months
  • Previous treatment with insulin within the last 6 months before randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Lantus once a day plus Glucophage 1000mg, twice a day per os
Drug: Lantus (insulin glargine) + Glucophage (Metformin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of the predictive criterion of HbA1c final
Time Frame: During the study conduct
During the study conduct
Determination of the predictive criterion of weight variation
Time Frame: During all the study conduct
During all the study conduct
HbA1c and weight variations (final value - basal value)
Time Frame: during the study
during the study
AE/SAE evaluation
Time Frame: from the informed consent signed up to the end of the study
from the informed consent signed up to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Nathalie Billon, sanofi-aventis administrative office France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ACTUAL)

September 1, 2004

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (ESTIMATE)

April 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2008

Last Update Submitted That Met QC Criteria

December 2, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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