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

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ClinicalTrials.gov Identifier: NCT00653302
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : December 3, 2008
Sponsor:
Information provided by:
Sanofi

Brief 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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. % 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 ]

Secondary Outcome Measures :
  1. Determination of the predictive criterion of HbA1c final [ Time Frame: During the study conduct ]
  2. Determination of the predictive criterion of weight variation [ Time Frame: During all the study conduct ]
  3. HbA1c and weight variations (final value - basal value) [ Time Frame: during the study ]
  4. AE/SAE evaluation [ Time Frame: from the informed consent signed up to the end of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653302


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

Responsible Party: Nathalie Billon/Study Director, sanofi-aventis France
ClinicalTrials.gov Identifier: NCT00653302     History of Changes
Other Study ID Numbers: HOE901_4043
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs