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

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ClinicalTrials.gov Identifier: NCT00642915
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Lantus, Amaryl Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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)
Study Start Date : June 2003
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Lantus, Amaryl
    Other Name: insulin glargine,glimepiride


Primary Outcome Measures :
  1. 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 :
  1. Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy [ Time Frame: 24 weeks ]


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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.

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

Publications:
Responsible Party: Study Director, Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00642915     History of Changes
Other Study ID Numbers: HOE901_4039
First Posted: March 25, 2008    Key Record Dates
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