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Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)

NCT ID: NCT00642915

Last Updated: 2008-08-25

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-07-31

Brief Summary

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To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

Detailed Description

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Conditions

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Diabetes Mellitus

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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Lantus, Amaryl

Intervention Type DRUG

Other Intervention Names

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insulin glargine,glimepiride

Eligibility Criteria

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Inclusion Criteria

* All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
* Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 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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Tadaaki Karino

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4.

Reference Type BACKGROUND
PMID: 17919763 (View on PubMed)

Other Identifiers

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HOE901_4039

Identifier Type: -

Identifier Source: org_study_id