Status:
COMPLETED
Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 s...
Detailed Description
The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The trial...
Eligibility Criteria
Inclusion
- 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 \<75
- Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)
Exclusion
- 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), 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 \<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)
- 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 \<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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00392678
Start Date
October 1 2006
End Date
December 1 2010
Last Update
April 8 2019
Active Locations (16)
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1
Chapel Medical Group
New Haven, Connecticut, United States, 06511
2
MedStar Research Institute
Washington D.C., District of Columbia, United States, 20003-4393
3
Endocrine Clinical Research
Winter Park, Florida, United States, 32746
4
Kaiser Permanente
Atlanta, Georgia, United States, 30084