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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain improved glycemic control with Lantus and Amaryl in Japanese type 2 diabetes patients?
How does Lantus plus Amaryl compare to other basal insulin-sulfonylurea combinations in preserving beta-cell function?
Which biomarkers correlate with endocrine pancreatic function preservation in NCT00642915 Japanese type 2 diabetes participants?
What adverse events are associated with Lantus and Amaryl combination therapy in non-Japanese type 2 diabetes populations?
What alternative combination therapies for Japanese type 2 diabetes patients have shown comparable efficacy to Lantus and Amaryl in phase 4 trials?
Trial Locations
- Locations (1)
Sanofi-Aventis
🇧🇷Sao Paulo, Brazil
Sanofi-Aventis🇧🇷Sao Paulo, Brazil