Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00799643

Run by

Joslin Diabetes Center

People needed

638

Starts

2008-11-01

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue (including SFU, non-SFU, and dipeptidyl peptidase IV (DPP-4) inhibitors), alpha-glucosidase inhibitors, or bile acid sequestrants (dosed once per day such that study drug can be administered ≥ 4 hours prior to sequestrant); or a combination of up to two of these at maximal dose. Dosing must be stable for 8 weeks prior to screening. Participant must have been diagnosed with T2D at least 8 weeks before screening.
• FPG ≤ 225 mg/dL and HbA1c≥7% and ≤ 9.5% at screening.
• Age ≥18 and <75
• Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)

You may not qualify if…

• No prior participation in Stage I of TINSAL-T2D ; exception: a participant who failed screening for HbA1c in Stage I will be allowed to re-screen for Stage II.
• Type 1 diabetes and/or history of ketoacidosis determined by medical history
• History of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
• History of long-term therapy with insulin (>30 days) within the last year
• Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), alone or in combination in the previous 6 months; or exendin-4 (Byetta), alone or in combination in the previous 3 months
• Pregnancy or lactation
• Patients requiring oral 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 <60 [possible chronic kidney disease stage 3 or greater calculated using the Modification of Diet in Renal Disease (MDRD) equation
• History of chronic liver disease including hepatitis B or C
• History of peptic ulcer or endoscopy demonstrated gastritis
• History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
• History of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
• New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
• History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
• Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg on three or more assessments on more than one day). If on blood pressure medications, dosing should be stable for 2 weeks prior to randomization.
• History of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed DCCktail containing 1 ounce of alcohol)
• Hemoglobin <12 g/dL (males), <10 g/dL (females) at screening*
• Platelets <100,000 cu mm at screening
• AST (SGOT) >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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California, San Diego — San Diego, California, United States
• Chapel Medical Group — New Haven, Connecticut, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Kaiser Permanente — Tucker, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Medstar Research Institute — Hyattsville, Maryland, United States
• Dr. Rudo, Westminster, MD — Westminster, Maryland, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• North Shore Diabetes and Endocrine Associates — New Hyde Park, New York, United States
• Columbia University — New York, New York, United States
• Lang Medical Center — Queens, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Carolina's Health Care — Charlotte, North Carolina, United States
• University of North Carolina — Durham, North Carolina, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Scott and White — Temple, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.