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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00653302
First received: April 1, 2008
Last updated: December 2, 2008
Last verified: December 2008

April 1, 2008
December 2, 2008
April 2003
September 2004   (final data collection date for primary outcome measure)
% 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653302 on ClinicalTrials.gov Archive Site
  • Determination of the predictive criterion of HbA1c final [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Determination of the predictive criterion of weight variation [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]
  • HbA1c and weight variations (final value - basal value) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • AE/SAE evaluation [ Time Frame: from the informed consent signed up to the end of the study ]
Same as current
Not Provided
Not Provided
 
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Lantus (insulin glargine) + Glucophage (Metformin)
Experimental: 1
Lantus once a day plus Glucophage 1000mg, twice a day per os
Intervention: Drug: Lantus (insulin glargine) + Glucophage (Metformin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
October 2005
September 2004   (final data collection date for primary outcome measure)

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
Both
30 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00653302
HOE901_4043
Not Provided
Nathalie Billon/Study Director, sanofi-aventis France
Sanofi
Not Provided
Study Director: Nathalie Billon Sanofi-aventis administrative office France
Sanofi
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP