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CompletedNCT00871936Updated Nov 18, 2023

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

A Phase 2 interventional study of SLx-4090 and Placebo in Type 2 Diabetes, sponsored by Response Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Response Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description
  1. HbA1c after 12 weeks
  2. FPG after 12 weeks
  3. Safety and tolerability
  4. Plasma levels of SLx-4090
02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 82 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Response Pharmaceuticals is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HbA1c 7-11%
  • On a stable dose of metformin for at least 6 weeks

Exclusion criteria

Exclusion Criteria:

  • Type 1 Diabetes
  • Antidiabetic medication other than or in addition to metformin
  • FPG > 270 mg/dL
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    1

    SLx-4090 in combination with Metformin

    Drug: SLx-4090 · Drug: Metformin

  • Other
    2

    Placebo

    Other: Placebo · Drug: Metformin

Interventions

  • DrugSLx-4090

    SLx-4090

  • OtherPlacebo

    matching tablets

  • DrugMetformin
06

What researchers measure

Primary outcomes

  1. Reduction in HbA1c

    Time frame: 12 weeks

Secondary outcomes

  1. Adverse Events

    Time frame: 12 weeks

07

Study locations

12 sites
  • Anaheim, California 92801, United States
  • Burbank, California 91505, United States
  • Los Angeles, California 90036, United States
  • Los Angeles, California 90057, United States
  • West Palm Beach, Florida 33401, United States
  • Addison, Illinois 60101, United States
  • Auburn, Maine 04210, United States
  • Charlotte, North Carolina 28211, United States
  • Hickory, North Carolina 28602, United States
  • Winston-Salem, North Carolina 27103, United States
  • Greenville, South Carolina 29615, United States
  • San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00871936
Lead sponsor
Response Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 30, 2009
Start date
Apr 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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