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| Sponsor: | Joslin Diabetes Center |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00799643 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Salsalate Drug: Salsalate Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate |
| Estimated Enrollment: | 564 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Salsalate, 3.5 g/d orally, divided dosing
|
Drug: Salsalate
Salsalate 3.5 g/d orally, divided dosing
|
|
2: Placebo Comparator
Salsalate Placebo, orally, divided dosing
|
Drug: Salsalate Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allison B. Goldfine, MD | 617-732-2643 | allison.goldfine@joslin.harvard.edu |
| Contact: Elizabeth Tatro | 617-732-2400 ext 4463 | elizabeth.tatro@joslin.harvard.edu |
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States | |
| Contact: Tiffany Grimes 205-934-4112 tdgrimes@uab.edu | |
| Principal Investigator: Fernando Ovalle, MD | |
| United States, California | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States | |
| Contact: Jacqueline Raceles 858-552-8585 ext 4384 Jacqueline.Raceles@va.gov | |
| Principal Investigator: Robert Henry, MD | |
| United States, Connecticut | |
| Chapel Medical Group | Recruiting |
| New Haven, Connecticut, United States | |
| Contact: Jennifer Flynn 203-865-5111 jjstrat16@yahoo.com | |
| Principal Investigator: Wayne Warren, MD | |
| United States, District of Columbia | |
| Medstar Research Institute | Recruiting |
| Washington, District of Columbia, United States | |
| Contact: Adeola Akindana 202-787-5313 adeola.akindana@medstar.net | |
| Principal Investigator: Vanita Aroda, MD | |
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States | |
| Contact: Gonzalo Robalino 404-616-3719 garobal@emory.edu | |
| Principal Investigator: Guillermo Umpierrez, MD | |
| Kaiser Permanente | Recruiting |
| Tucker, Georgia, United States | |
| Contact: Michelle Stevens 770-496-3421 Michelle.D.Stevens@kp.org | |
| Principal Investigator: Joshua Barzilay, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Robin Chisholm 317-274-7679 rlchisho@iupui.edu | |
| Principal Investigator: Kieren Mather, MD | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | Recruiting |
| New Orleans, Louisiana, United States | |
| Contact: Pat Reilly 504-988-4651 preilly@tulane.edu | |
| Principal Investigator: Vivian Fonseca, MD | |
| United States, Massachusetts | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Elizabeth Tatro 617-735-1940 elizabeth.tatro@joslin.harvard.edu | |
| Contact: Allison B. Goldfine, MD 617-732-2643 allison.goldfine@joslin.harvard.edu | |
| Principal Investigator: Allison B. Goldfine, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Cindy Plunkett 734-936-8065 cplunket@med.umich.edu | |
| Principal Investigator: Rodica Pop-Busui, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States | |
| Contact: Sarah Kissel 314-362-8688 skissel@wustl.edu | |
| Principal Investigator: Janet McGill, MD | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omana, Nebraska, United States | |
| Contact: Peggy Karatoprakli 402-995-4163 peggy.karatoprakli@va.gov | |
| Principal Investigator: Cyrus Desouza, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York City, New York, United States | |
| Contact: Carlos Lopez Jimenez 212-305-2920 CL517@columbia.edu | |
| Contact: Leocar Mesa (212) 305-8797 lm2537@columbia.edu | |
| Principal Investigator: Daniel Donovan, MD | |
| North Shore Diabetes and Endocrine Associates | Recruiting |
| Ney Hyde Park, New York, United States | |
| Contact: Mini Thomas 516-327-0850 ext 256 mthomas@nsdea.com | |
| Principal Investigator: Kenneth Hershon, MD | |
| Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States | |
| Contact: Janet Brown 718-405-8266 jabrown@aecom.yu.edu | |
| Principal Investigator: Jill Crandall, MD | |
| Lang Medical Center | Recruiting |
| Queens, New York, United States | |
| Contact: Maria Roccisano mar9176@nyp.org | |
| Principal Investigator: Dan Lorber, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Durham, North Carolina, United States | |
| Contact: Gail Fuller 919-484-0931 ext 274 gail_fuller@med.unc.edu | |
| Principal Investigator: John Buse, MD | |
| Carolina's Health Care | Recruiting |
| Charlotte, North Carolina, United States | |
| Contact: Carol Morris 704-446-7736 carol.morris@carolinas.org | |
| Principal Investigator: Thomas Barringer, MD | |
| United States, Texas | |
| University of Texas Southwestern | Recruiting |
| Dallas, Texas, United States | |
| Contact: Renee Smalley 214-648-9470 Renee.smalley@utsouthwestern.edu | |
| Principal Investigator: Phillip Raskin, MD | |
| Scott and White | Recruiting |
| Temple, Texas, United States | |
| Contact: Sarah Allenson 254-215-0306 sallenson@swmail.sw.org | |
| Principal Investigator: Veronica Piziak, MD | |
| 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 School of Medicine |
| Study Director: | Kathleen Jablonski, PhD | George Washington University |
| Study Director: | Myrlene Staten, MD | National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) |
More Information
| Responsible Party: | Joslin Diabetes Center, Boston, MA ( Dr. Allison B. Goldfine, MD ) |
| Study ID Numbers: | CHS 06-20-2, UO1-DK074556 |
| Study First Received: | November 26, 2008 |
| Last Updated: | September 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00799643 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 2 Diabetes Mellitus (T2D) Inflammation Obesity Metabolic Syndrome Salicylates |
|
Diabetes Mellitus, Type 2 Anti-Inflammatory Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Salicylsalicylic acid Diabetes Mellitus Sodium Salicylate Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions |
Inflammation Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Glucose Metabolism Disorders Central Nervous System Agents |