20 Week Bridging Study in Type II DM

NCT ID: NCT00563225

Last Updated: 2007-11-26

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

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-04-30

Brief Summary

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A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus

Detailed Description

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Conditions

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Diabetes Mellitus Type II

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Insulin Glargine

Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)

Intervention Type DRUG

Other Intervention Names

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Lantus

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes Mellitus diagnosed at least 3 years ago
* Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
* Treated with OHA monotherapy over at least 1 year
* HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
* BMI \< 40 kg/m2
* No history of ketonemia
* Women of childbearing potential using the medically approved contraceptive method
* Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol

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

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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Choe Seong Choon

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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HOE901_3506

Identifier Type: -

Identifier Source: org_study_id