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
  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:


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
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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
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014