Trial Outcomes & Findings for Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance? (NCT NCT02007577)

NCT ID: NCT02007577

Last Updated: 2016-05-05

Results Overview

Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: after treatment for one month
• Results posted on: 2016-05-05

Participant Flow

Participant milestones

Measure	Salsalate 3500mg in 2 Divided Doses a Day Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner
Overall Study STARTED	27	14
Overall Study COMPLETED	26	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Salsalate 3500mg in 2 Divided Doses a Day Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?

Baseline characteristics by cohort

Measure	Salsalate 3500mg in 2 Divided Doses a Day n=26 Participants Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo n=13 Participants Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner	Total n=39 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 10 • n=5 Participants	54 years STANDARD_DEVIATION 10 • n=7 Participants	54 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: after treatment for one month

Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group

Outcome measures

Measure	Salsalate 3500mg in 2 Divided Doses a Day n=26 Participants Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo n=13 Participants Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner
Quantification of Insulin Action With the Insulin Suppression Test (IST)	-3 mmol/L Interval -10.0 to 5.0	2 mmol/L Interval -9.0 to 12.0

SECONDARY outcome

Timeframe: one month on treatment

compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo

Outcome measures

Measure	Salsalate 3500mg in 2 Divided Doses a Day n=26 Participants Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo n=13 Participants Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner
Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)	-6 pmol/min x 4h Interval -12.0 to 0.0	0 pmol/min x 4h Interval -9.0 to 9.0

Adverse Events

Salsalate 3500mg in 2 Divided Doses a Day

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Salsalate 3500mg in 2 Divided Doses a Day n=27 participants at risk Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner	Placebo n=14 participants at risk Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner
Gastrointestinal disorders 3 years	3.7% 1/27 • Number of events 1	0.00% 0/14
Ear and labyrinth disorders tinnitus	3.7% 1/27 • Number of events 4	0.00% 0/14

Additional Information

Dr. Gerald Reaven

Stanford Universtiy

Phone: 650-724-3416

Email: greaven@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place