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

Phase 4

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00642915
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-07
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-22
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy	24 weeks

Trial Locations

Locations (1)

Sanofi-Aventis; 🇧🇷 Sao Paulo, Brazil