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OpenTrials
Completed

NCT Number: NCT00871936

A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim, California, United States

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About this study

  • HbA1c after 12 weeks
  • FPG after 12 weeks
  • Safety and tolerability
  • Plasma levels of SLx-4090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLx-4090

Drug

SLx-4090

Placebo

Other

matching tablets

metformin

Drug

Primary outcomes

  1. Reduction in HbA1c

    Time frame: 12 weeks

Secondary outcomes

  1. Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Response Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2009
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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