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COMPLETED Phase 2

Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)

NCT00392678 · View on ClinicalTrials.gov ↗

Study 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. The first stage is a dose ranging study, administering salsalate compared to placebo over three months. 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. The second stage is a second trial and posted under alternate registration.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Salsalate

Study Locations (16)

New York

  • Kaleida Health Center — Buffalo
  • North Shore Diabetes and Endocrine Associates — New Hyde Park
  • Columbia University — New York
  • University of Rochester Medical Center — Rochester

Georgia

  • Kaiser Permanente — Atlanta
  • Emory School of Medicine — Atlanta

Connecticut

  • Chapel Medical Group — New Haven

District of Columbia

  • MedStar Research Institute — Washington D.C.

Florida

  • Endocrine Clinical Research — Winter Park

Illinois

  • University of Illinois at Chicago — Chicago

Louisiana

  • Tulane University — New Orleans

Massachusetts

  • Joslin Diabetes Center — Boston

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2006-10
Est. Completion 2010-12
Phase Phase 2

Sponsor

Joslin Diabetes Center

87 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00392678

The ClinicalTrials.gov registry entry for NCT00392678 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joslin Diabetes Center, which has 87 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00392678 reports 16 study locations spanning 12 distinct geographic areas — top geographies include New York, Georgia, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00392678 about?

NCT00392678 is a clinical study titled "Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)". 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 effec...

What is the current status of trial NCT00392678?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2006-10. Estimated completion is 2010-12.

What conditions does trial NCT00392678 study?

This clinical trial studies the following conditions: Type 2 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00392678?

The interventions under investigation include: Placebo (DRUG), Salsalate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00392678?

This trial is sponsored by Joslin Diabetes Center, which has 87 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00392678 being conducted?

This trial has 16 study locations across Connecticut, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial