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

Phase 2CompletedNCT00871936

Response Pharmaceuticals82 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

SLx-4090DRUG

SLx-4090

PlaceboOTHER

matching tablets

MetforminDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Burbank, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Reduction in HbA1c

Time frame: 12 weeks

Secondary Outcomes

Adverse Events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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