Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Lantus, Amaryl (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Tadaaki Karino, Study Director, Affiliation: Sanofi
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
Clinical Details
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)
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Sao Paulo, Brazil
Additional Information
Related publications: 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.
Starting date: June 2003
Last updated: August 22, 2008
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