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 |
|---|---|
| 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 |
|---|---|
| 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) |
|---|---|
| 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 |
|---|---|
| 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 |
|---|---|
| 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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