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

Condition(s) targeted: Diabetes Mellitus

Intervention: Lantus, Amaryl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Tadaaki Karino, Study Director, Affiliation: Sanofi-Aventis

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

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: Treatment, Non-Randomized, Open Label, Single Group Assignment

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

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.

Sanofi-Aventis, Sao Paulo, Brazil

clinicalstudyresults.org

Starting date: June 2003
Ending date: July 2004
Last updated: March 26, 2008