Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT00799643
Previous Study | Return to List | Next Study

Targeting Inflammation Using Salsalate for Type 2 Diabetes-stage II (TINSAL-T2D-II)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00799643
First received: November 26, 2008
Last updated: March 25, 2014
Last verified: March 2014

November 26, 2008
March 25, 2014
November 2008
September 2012   (final data collection date for primary outcome measure)
The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups. [ Time Frame: 48 weeks from baseline ] [ Designated as safety issue: No ]
HbA1c (%, percentage of HbA1c) change from baseline.
The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 48, compared between treatment groups. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00799643 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Glucose Over Time. [ Time Frame: 48 weeks from baseline ] [ Designated as safety issue: Yes ]
  • Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8% [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Response rates for reduction in fasting glucose of ≥20 mg/dl, a reduction in HbA1c of ≥0.5%, and a reduction in HbA1c of ≥0.8% [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Change in lipids (low-density lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], triglycerides [TG], total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], TC/HDL-C ratio, and LDL-C/HDL-C ratio) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in insulin sensitivity [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Changes in WBC and differential, high-sensitivity C reactive protein (hsCRP), other inflammatory markers [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline and trends in fasting glucose over time. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Response rates for exceeding hyperglycemic targets between active and placebo treated groups; Need for rescue therapy; Need for discontinuation of study medication [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Response rates in patients initially treated with lifestyle modification, insulin secretagogue, metformin or combination therapy [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Targeting Inflammation Using Salsalate for Type 2 Diabetes-stage II
Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Salsalate
    Salsalate 3.5 g/d orally, divided dosing
    Other Name: Disalsid
  • Drug: Salsalate Placebo
  • Active Comparator: 1
    Salsalate, 3.5 g/d orally, divided dosing
    Intervention: Drug: Salsalate
  • Placebo Comparator: 2
    Salsalate Placebo, orally, divided dosing
    Intervention: Drug: Salsalate Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
638
Not Provided
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. FPG ≤ 225 mg/dL and HbA1c≥7% and ≤ 9.5% at screening.
  3. Age ≥18 and <75
  4. Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)

Exclusion Criteria:

  1. 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.
  2. Type 1 diabetes and/or history of ketoacidosis determined by medical history
  3. History of severe diabetic neuropathy including autonomic neuropathy, gastroporesis or lower limb ulceration or amputation
  4. History of long-term therapy with insulin (>30 days) within the last year
  5. Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), alone or in combination in the previous 6 months; or extendin-4 (Byetta), alone or in combination in the previous 3 months
  6. Pregnancy or lactation
  7. Patients requiring oral corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
  8. 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
  9. Surgery within 30 days prior to screening
  10. 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
  11. History of chronic liver disease including hepatitis B or C
  12. History of peptic ulcer or endoscopy demonstrated gastritis
  13. History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
  14. 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
  15. New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
  16. History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
  17. 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.
  18. 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)
  19. Hemoglobin <12 g/dL (males), <10 g/dL (females) at screening*
  20. Platelets <100,000 cu mm at screening
  21. AST (SGOT) >2.50 x ULN or ALT (SGPT) >2.50 x ULN at screening
  22. Total Bilirubin >1.50 x ULN at screening
  23. Triglycerides (TG) >500 mg/dL at screening
  24. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
  25. Previous allergy to aspirin
  26. Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
  27. Use of warfarin (Coumadin), clopidogrel (Plavix), dipyridamole (Persantine), heparin or other anticoagulants
  28. Use of probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents
  29. Macroalbuminuria, defined as spot urine protein >300 mcg/mg Cr at screening
  30. Pre-existing chronic tinnitus
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00799643
CHS 06-20-2, UO1-DK074556
Yes
Allison Goldfine, Joslin Diabetes Center
Allison Goldfine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven E. Shoelson, MD, PhD Joslin Diabetes Center
Study Director: Allison B. Goldfine, MD Joslin Diabetes Center
Study Director: Vivian Fonseca, MD Tulane University
Study Director: Kathleen Jablonski, PhD George Washington University
Study Director: Myrlene Staten, MD National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP