Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
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...
Brief Summary
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)”
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
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Lantus, Amaryl
Outcome Measures for this Clinical Trial
Primary 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.
Safety Issue?: No
- Time Frame: Hemoglobin A1c values were measured at Screening and at every visit thereafter.
Secondary Measures
- Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
- Time Frame: 24 weeks
Safety Issue?: No
- Time Frame: 24 weeks
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Tadaaki Karino Study Director Sanofi-Aventis
Related Publications
References
Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. Epub 2007 Oct 4.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642915
Study ID Number: HOE901_4039
ClinicalTrials.gov Identifier: NCT00642915
Health Authority: Brazil: National Committee of Ethics in Research
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00642915
