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

November 14, 2023 updated by: Response Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Placebo
Drug: Metformin
Other: Placebo
matching tablets
Experimental: 1
SLx-4090 in combination with Metformin
Drug: Metformin
Drug: SLx-4090
SLx-4090

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in HbA1c
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Response Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimated)

March 30, 2009

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLx-4090-09-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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