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NCT00642915 Clinical Trial

Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)

Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00642915
Other study ID # HOE901_4039
Secondary ID
Status Completed
Phase Phase 4
First received March 19, 2008
Last updated August 22, 2008
Start date June 2003
Est. completion date July 2004

Study information
Verified date August 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lantus, Amaryl

Locations
Country Name City State
Brazil Sanofi-Aventis Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Hemoglobin A1c values were measured at Screening and at every visit thereafter. No
Secondary Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy 24 weeks No
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