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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00642915
First received: March 19, 2008
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  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: 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 19, 2008
Last Updated: August 22, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 16, 2013