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

August 22, 2008 updated by: Sanofi

A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy
Time Frame: Hemoglobin A1c values were measured at Screening and at every visit thereafter.
Hemoglobin A1c values were measured at Screening and at every visit thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Tadaaki Karino, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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