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Sponsors and Collaborators: |
Joslin Diabetes Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Joslin Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00392678 |
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. The primary objective of the first stage is 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 |
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Type 2 Diabetes |
Drug: Salsalate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate |
Estimated Enrollment: | 402 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2010 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Salsalate
Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
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2: Active Comparator |
Drug: Salsalate
Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
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3: Active Comparator |
Drug: Salsalate
Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
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4: Active Comparator |
Drug: Salsalate
Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Chapel Medical Group | |
New Haven, Connecticut, United States | |
United States, District of Columbia | |
MedStar Research Institute | |
Washington DC, District of Columbia, United States | |
United States, Florida | |
Endocrine Clinical Research | |
Winter Park, Florida, United States | |
United States, Georgia | |
Emory School of Medicine | |
Atlanta, Georgia, United States | |
Kaiser Permanente | |
Atlanta, Georgia, United States | |
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States | |
United States, Louisiana | |
Tulane University | |
New Orleans, Louisiana, United States | |
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States | |
United States, New York | |
Columbia University | |
New York City, New York, United States | |
Kaleida Health Center | |
Buffalo, New York, United States | |
North Shore Diabetes and Endocrine Associates | |
New Hyde Park, New York, United States | |
University of Rochester Medical Center | |
Rochester, New York, United States | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States | |
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States |
Principal Investigator: | Steven E. Sheolson, 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 |
Responsible Party: | Joslin Diabetes Center, Boston, MA ( Allison Goldfine, MD ) |
Study ID Numbers: | CHS 06-20, U01 DK074556 |
Study First Received: | October 25, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00392678 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
Type 2 Diabetes Inflammation Obesity Metabolic Syndrome |
Obesity Metabolic Diseases Salicylsalicylic acid Diabetes Mellitus, Type 2 Salicylates Sodium Salicylate |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Inflammation |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |