A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SLx-4090; Other: Placebo; Drug: Metformin

• 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

Study Timeline

• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-30
• Study Start: 2009-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Disposition First Submitted: 2014-12-09
• Disposition First Submitted QC: 2014-12-09
• Disposition First Posted: 2014-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

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