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NCT00871936 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of SLx-4090 in Combination With Metformin in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00871936
Other study ID # SLx-4090-09-07
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2009
Est. completion date October 2009

Study information
Verified date April 2023
Source Response Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

1. HbA1c after 12 weeks 2. FPG after 12 weeks 3. Safety and tolerability 4. Plasma levels of SLx-4090

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SLx-4090
SLx-4090
Other:
• Placebo
matching tablets
Drug:
• Metformin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Response Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in HbA1c 12 weeks
Secondary Adverse Events 12 weeks
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