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...
Date First Received: March 19, 2008
Last Updated: August 22, 2008
Verified by: Sanofi-Aventis, August 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2003
Overall Status: Completed
Estimated Enrollment: 100
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)”
Condition Keyword(s):
Intervention(s):
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: Treatment, Non-Randomized, Open Label, Single Group Assignment
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 Sponsor Information
Lead Sponsor: Sanofi-Aventis
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 October 10, 2008
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
Clinical Trials Authorship and Review
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