LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

NCT ID: NCT00349986

Last Updated: 2009-12-07

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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The rationale of the study is to determine:

* the first dose and the titration of basal insulin
* the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Insuline glargine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes Mellitus
* Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
* BMI \>25 kg/m2 , \<30 kg/m2
* HbA1c value \>7.0%, \<9.0% within one month

Exclusion Criteria

* Type 1 Diabetes Mellitus
* Known malignancy
* Drug or alcohol abuse
* Severe liver disease
* Renal failure (se Creatinine \> 150 micro mol/l)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 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

Principal Investigators

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László Erős, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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HOE901_4059

Identifier Type: -

Identifier Source: org_study_id