Trial Outcomes & Findings for Effect of Salicylate on Glucose Metabolism in Insulin Resistance States (NCT NCT00258128)

NCT ID: NCT00258128

Last Updated: 2019-04-30

Results Overview

fasting glucose

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-04-30

Participant Flow

This study was active between 2000-2008. The location was an accademic clinic setting in the USA.

Subjects were instructed to monitor fasting blood glucose levels and with symptoms of hyperglycemia or hypoglycemia, and to avoid changing dietary or exercise habits.

Participant milestones

Measure	Salsalate 4.0 g/d	Placebo
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Salicylate on Glucose Metabolism in Insulin Resistance States

Baseline characteristics by cohort

Measure	Salsalate n=8 Participants Randomized cohorts - Active	Placebo n=9 Participants Randomized cohorts - Placebo	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=5 Participants	54 years STANDARD_DEVIATION 8 • n=7 Participants	52 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Receiving one dose of study drug and with measured value

fasting glucose

Outcome measures

Measure	Placebo n=9 Participants Fasting glucose	Salsalate n=8 Participants Fasting glucose
Glucose	7.1 mmol/L Standard Deviation 0.3	6.4 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Placebo n=8 Participants Fasting glucose	Salsalate n=9 Participants Fasting glucose
Adiponectin	22.7 mg/ml Standard Deviation 2.5	10.6 mg/ml Standard Deviation 2.0

Adverse Events

Salsalate

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Allison B. Goldfine, MD

Joslin Diabetes Center

Phone: 617-309-2400

Email: allison.goldfine@joslin.harvard.edu

Results disclosure agreements

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