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

NCT ID: NCT00653302

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Lantus once a day plus Glucophage 1000mg, twice a day per os

Group Type EXPERIMENTAL

Lantus (insulin glargine) + Glucophage (Metformin)

Intervention Type DRUG

Interventions

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Lantus (insulin glargine) + Glucophage (Metformin)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis France

Principal Investigators

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Nathalie Billon

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office France

Locations

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Sanofi-aventis administrative office

Paris, , France

Site Status

Countries

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France

Other Identifiers

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HOE901_4043

Identifier Type: -

Identifier Source: org_study_id