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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871936

Enrollment

Registered

2009-03-30

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Detailed description

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

Interventions

DRUGSLx-4090

SLx-4090

OTHERPlacebo

matching tablets

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in HbA1c	12 weeks

Secondary

Measure	Time frame
Adverse Events	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026