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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642915
First Posted: March 25, 2008
Last Update Posted: August 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
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

Condition Intervention Phase
Diabetes Mellitus Drug: Lantus, Amaryl Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy [ Time Frame: 24 weeks ]

Enrollment: 100
Study Start Date: June 2003
Study Completion Date: July 2004
Intervention Details:
    Drug: Lantus, Amaryl
    Other Name: insulin glargine,glimepiride
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642915


Locations
Brazil
Sanofi-Aventis
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tadaaki Karino Sanofi
  More Information

Publications:
Responsible Party: Study Director, Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00642915     History of Changes
Other Study ID Numbers: HOE901_4039
First Submitted: March 19, 2008
First Posted: March 25, 2008
Last Update Posted: August 25, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors