A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
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
1 other identifier
interventional
82
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Apr 2009
Shorter than P25 for phase_2 type-2-diabetes
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedNovember 18, 2023
April 1, 2023
6 months
March 26, 2009
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in HbA1c
12 weeks
Secondary Outcomes (1)
Adverse Events
12 weeks
Study Arms (2)
1
EXPERIMENTALSLx-4090 in combination with Metformin
2
OTHERPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- HbA1c 7-11%
- On a stable dose of metformin for at least 6 weeks
You may not qualify if:
- Type 1 Diabetes
- Antidiabetic medication other than or in addition to metformin
- FPG \> 270 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Burbank, California, 91505, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Addison, Illinois, 60101, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Charlotte, North Carolina, 28211, United States
Unknown Facility
Hickory, North Carolina, 28602, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 18, 2023
Record last verified: 2023-04