# Effect of Salsalate on Glycemic Control in Type 2 Diabetes Patients on Insulin

> **NIH NIH P20** · TULANE UNIVERSITY OF LOUISIANA · 2020 · $214,348

## Abstract

Project Summary (Research Project 2)
Type 2 diabetes mellitus (T2DM) is a progressive disease with many patients requiring insulin therapy.
Treatment of patients with T2DM is challenging and many such patients remain uncontrolled, despite a high
dosage of insulin, which itself tends to lead to weight gain. Tackling insulin resistance (IR) is critically important
in the treatment of patients with T2DM, but effective treatment options are limited. Recent studies suggest that
chronic inflammation, mediated by the IKKb/NF-kB pathway, may be implicated in the pathogenesis of IR and
may provide new targets for its reversal. Salsalate (Disalcid) is a prodrug form of salicylate. The Targeting
INflammation using SALsalate for Type 2 Diabetes Stage II (TINSAL-T2D) trial demonstrated the efficacy and
safety of oral salsalate, given at a dose of 3.5 gm/day, in improving glycemic control in patients with T2DM who
were not using insulin. Salsalate also suppresses inflammatory markers and may have beneficial effects on
cardiovascular disease (CVD) risk factors. The benefit and safety of adjuvant therapy with salsalate in patients
with T2DM using insulin are unknown. The efficacy of salsalate on glycated hemoglobin (HbA1c), insulin
resistance, markers of inflammation and beta cell function has not been studied in such patients. Our
hypothesis is that treatment with salsalate 3.5 gm/day will provide additional glycemic control in patients with
T2DM on insulin and will improve markers of inflammation, beta cell function and surrogate markers of CVD
risk. We propose to test this hypothesis by conducting a randomized, double-blind, placebo-controlled trial with
the following specific aims: Determine whether the addition of oral salsalate, at a dose of 3.5 gm/day, in
patients with T2DM on insulin therapy leads to improvement in: 1. glycemic control (HbA1c); 2. markers of
inflammation, such as white cell count, high-sensitivity C-reactive protein, free fatty acids, adiponectin,
interleukin-6, and serum uric acid, and 3. insulin sensitivity and beta cell function, based on the results of a
mixed meal tolerance test with minimal model assessment. In addition, we will test for differences in quality of
life using SF36 surveys; and differences in other CVD risk factors, including lipids and endothelial function and
vascular compliance using noninvasive testing (EndoPAT). One hundred and forty patients with uncontrolled
T2DM despite insulin therapy will be randomized to receive salsalate or placebo. We anticipate 90% statistical
power to detect a 0.5% difference in HbA1c change between the salsalate treatment and placebo control
groups over a 6 month period of intervention. The study will confirm proof of concept and provide important
insight into the safety and efficacy of oral salsalate use in patients with T2DM on insulin therapy. The proposed
COBRE program will provide the junior faculty investigator with the protected-time and funding necessary to
conduct high quality...

## Key facts

- **NIH application ID:** 9930644
- **Project number:** 5P20GM109036-05
- **Recipient organization:** TULANE UNIVERSITY OF LOUISIANA
- **Principal Investigator:** Tina Kaur Thethi
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $214,348
- **Award type:** 5
- **Project period:** — → 2022-07-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9930644

## Citation

> US National Institutes of Health, RePORTER application 9930644, Effect of Salsalate on Glycemic Control in Type 2 Diabetes Patients on Insulin (5P20GM109036-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9930644. Licensed CC0.

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