A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
- Registration Number
- NCT00871936
- Lead Sponsor
- Response Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.
- Detailed Description
1. HbA1c after 12 weeks
2. FPG after 12 weeks
3. Safety and tolerability
4. Plasma levels of SLx-4090
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
- HbA1c 7-11%
- On a stable dose of metformin for at least 6 weeks
Exclusion Criteria
- Type 1 Diabetes
- Antidiabetic medication other than or in addition to metformin
- FPG > 270 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 SLx-4090 SLx-4090 in combination with Metformin 2 Placebo Placebo 2 Metformin Placebo 1 Metformin SLx-4090 in combination with Metformin
- Primary Outcome Measures
Name Time Method Reduction in HbA1c 12 weeks
- Secondary Outcome Measures
Name Time Method Adverse Events 12 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 SLx-4090's synergistic effect with metformin on HbA1c reduction in Type 2 Diabetes?
How does the efficacy of SLx-4090 plus metformin compare to metformin monotherapy in reducing HbA1c and fasting plasma glucose in Type 2 Diabetes patients?
Which biomarkers correlate with improved glycemic control in NCT00871936's SLx-4090 and metformin combination therapy for Type 2 Diabetes?
What are the safety profiles and adverse event management strategies for SLx-4090 combined with metformin in Type 2 Diabetes patients?
Are there other investigational agents or combination therapies targeting similar metabolic pathways as SLx-4090 in Type 2 Diabetes management?