Phase 3
Completed N=108
Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)
Source: ClinicalTrials.gov NCT00392678 ↗Enrolled (actual)
108
Serious AEs
3.7%
Results posted
Jul 2013
Primary outcomePrimary: Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1 — -0.36; -0.34; -0.49; -0.01 % (units of HbA1c) — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1 |
-0.36; -0.34; -0.49; -0.01 | <0.05 sig |
| SECONDARY Change in HbA1c |
0; -0.4; -0.3; -0.5 | — |
| SECONDARY Change From Baseline and Trends in Fasting Glucose Over Time |
13; -19; -14; -15 | — |
| SECONDARY Change in Lipids |
0; 8; -1; 6; 0; 3 | — |
| SECONDARY Change From Baseline in 14-week Insulin, C-peptide, Homeostasis Model [HOMA] Index |
-3.0; 15; 7.6; 27 | — |
| SECONDARY Safety and Tolerability |
17; 16; 16; 14 | — |
| SECONDARY Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index |
0.10; -0.07; -0.03; 0.03 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at ≤ 50% maximal dose (see Appendix). Dosing is stable for 8 weeks prior to randomization.
- FPG ≤ 225 mg/dL and HbA1c>7% and ≤9.5% at screening
- Age ≥18 and 30 days) within the last year
- Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), or extendin-4 (Byetta), alone or in combination in the previous 6 months
- Pregnancy or lactation
- Patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
- Use of weight loss drugs [e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
- Surgery within 30 days prior to screening
- Serum creatinine >1.4 for women and >1.5 for men or eGFR 150 mmHg or diastolic blood pressure >95 mmHg on three or more assessments on more than one day)
- History of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
- Hemoglobin 2.50 x ULN or ALT (SGPT) >2.50 x ULN at screening
- Total Bilirubin >1.50 x ULN at screening
- Triglycerides (TG) >500 mg/dL at screening
- Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
- Previous allergy to aspirin
- Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
- Use of warfarin (Coumadin), clopidogrel (Plavix) or other anticoagulants
- Use of probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents
Data sourced from ClinicalTrials.gov (NCT00392678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.