At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
Salsalate +1 moredrug
Likely dose
Salsalate (specific dose not stated in published record)AI-extracted
Key inclusion· 5
- ✓Age 18 to 65 years, inclusive
- ✓HbA1c >6.0% (off medication-diabetic)
- ✓Normal hemoglobin and hematocrit, without blood donation in previous 2 months
- ✓Not involved in any study evaluating an investigational drug or device for the previous 2 months
Key exclusion· 16
- ✕Pregnant or lactating women
- ✕Current or previous use of insulin for glucose control
- ✕Persistent ketonuria or history of ketoacidosis
- ✕Abnormal liver function: bilirubin, alkaline phosphatase, ALT, AST, or GGTP >1.5× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Salicylate on Glucose Metabolism in Insulin Resistance States
In Brief
A Phase 2 clinical trial evaluating Salsalate and Placebo for Insulin Resistance. Completed, enrolled 17 participants.
Detailed Summary
Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin Resistance
Countries--
Timeline
Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2000
First PostedNov 2005
Primary CompletionMay 2008
TodayJul 2026
First PostedNov 24, 2005
Enrollment StartJan 1, 2000
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.6 years ago
Interventions
Salsalatedrug
Active
Placebodrug
Placebo for salslate, used only in the third trial