Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
Overview[ - collapse ][ - ]
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 |
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Condition | Diabetes Mellitus |
Intervention | Drug: Lantus, Amaryl |
Phase | Phase 4 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT00642915 |
First Received | March 19, 2008 |
Last Updated | August 22, 2008 |
Last verified | August 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | March 19, 2008 |
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Last Updated Date | August 22, 2008 |
Start Date | June 2003 |
Estimated Primary Completion Date | July 2004 |
Current 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] |
Current 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] |
Descriptive Information[ + expand ][ + ]
Brief Title | Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil) |
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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) |
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 |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus |
Intervention | Drug: Lantus, Amaryl Other Names: insulin glargine,glimepiride |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 100 |
Estimated Completion Date | July 2004 |
Estimated Primary Completion Date | Not Provided |
Eligibility 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. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00642915 |
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Other Study ID Numbers | HOE901_4039 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Study Director: Tadaaki Karino Sanofi |
Verification Date | August 2008 |
Locations[ + expand ][ + ]
Sanofi-Aventis | Sao Paulo, Brazil |
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