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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
History of Changes
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes
 Drug: Lantus (insulin glargine) + Glucophage (Metformin)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • % 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 280
Study Start Date: April 2003
Study Completion Date: October 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lantus once a day plus Glucophage 1000mg, twice a day per os
 Drug: Lantus (insulin glargine) + Glucophage (Metformin)

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653302

Locations
France
Sanofi-aventis administrative office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Billon Sanofi-aventis administrative office France
  More Information

No publications provided

Responsible Party: Nathalie Billon/Study Director, sanofi-aventis France
ClinicalTrials.gov Identifier: NCT00653302     History of Changes
Other Study ID Numbers: HOE901_4043
Study First Received: April 1, 2008
Last Updated: December 2, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013