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

NCT ID: NCT00871936

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

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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

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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

SLx-4090 in combination with Metformin

Group Type EXPERIMENTAL

SLx-4090

Intervention Type DRUG

SLx-4090

Metformin

Intervention Type DRUG

2

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

matching tablets

Metformin

Intervention Type DRUG

Interventions

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SLx-4090

SLx-4090

Intervention Type DRUG

Placebo

matching tablets

Intervention Type OTHER

Metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Response Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hickory, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Anaheim, California, United States

Site Status

Burbank, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Addison, Illinois, United States

Site Status

Auburn, Maine, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Greenville, South Carolina, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SLx-4090-09-07

Identifier Type: -

Identifier Source: org_study_id

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