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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate |
| Estimated Enrollment: | 564 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Salsalate, 3.5 g/d orally, divided dosing
|
Drug: Salsalate
Salsalate 3.5 g/d orally, divided dosing
Other Name: Disalsid
|
|
Placebo Comparator: 2
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| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States | |
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States | |
| United States, Connecticut | |
| Chapel Medical Group | |
| New Haven, Connecticut, United States | |
| United States, Georgia | |
| Emory University School of Medicine | |
| Atlanta, Georgia, United States | |
| Kaiser Permanente | |
| Tucker, Georgia, United States | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Medstar Research Institute | |
| Hyattsville, Maryland, United States | |
| Dr. Rudo, Westminster, MD | |
| Westminster, Maryland, United States, 21157 | |
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omana, Nebraska, United States | |
| United States, New York | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States | |
| Columbia University | |
| New York City, New York, United States | |
| North Shore Diabetes and Endocrine Associates | |
| Ney Hyde Park, New York, United States | |
| Lang Medical Center | |
| Queens, New York, United States | |
| United States, North Carolina | |
| Carolina's Health Care | |
| Charlotte, North Carolina, United States | |
| University of North Carolina | |
| Durham, North Carolina, United States | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States | |
| Scott and White | |
| Temple, Texas, United States | |
| 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: | Dr. Allison B. Goldfine, MD, Joslin Diabetes Center, Boston, MA |
| ClinicalTrials.gov Identifier: | NCT00799643 History of Changes |
| Other Study ID Numbers: | CHS 06-20-2, UO1-DK074556 |
| Study First Received: | November 26, 2008 |
| Last Updated: | October 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Type 2 Diabetes Mellitus (T2D) Inflammation Obesity Metabolic Syndrome Salicylates |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Inflammation Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Sodium Salicylate Salicylsalicylic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |