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Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II

NCT00799643 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2017-12-11

Study results available
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Summary

Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. Enrollment in the first stage is complete. The primary objective of the first stage was to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.

Conditions

Interventions

DRUG

Salsalate

Salsalate 3.5 g/d orally, divided dosing

DRUG

Salsalate Placebo

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Steven E. Shoelson, MD, PhD · Joslin Diabetes Center

  • Allison B. Goldfine, MD · Joslin Diabetes Center

  • Vivian Fonseca, MD · Tulane University

  • Kathleen Jablonski, PhD · George Washington University

  • Myrlene Staten, MD · National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799643 on ClinicalTrials.gov