Clinical trial NCT00653302: Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 280
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
timeFrame: During the study conduct
Secondary outcomes:
measure: Determination of the predictive criterion of HbA1c final
timeFrame: During the study conduct
measure: Determination of the predictive criterion of weight variation
timeFrame: During all the study conduct
measure: HbA1c and weight variations (final value - basal value)
timeFrame: during the study
measure: AE/SAE evaluation
timeFrame: from the informed consent signed up to the end of the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office France
name: Nathalie Billon
role: STUDY_DIRECTOR
References: