Trial Outcomes & Findings for Pilot Study to Determine Effects of Salsalate in Type 1 Diabetes and Painful Peripheral Neuropathy (NCT NCT01480297)

NCT ID: NCT01480297

Last Updated: 2015-04-24

Results Overview

Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2015-04-24

Participant Flow

Recruitment was completed in 3 months time.

Participant milestones

Measure	Salsalate All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner). Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study to Determine Effects of Salsalate in Type 1 Diabetes and Painful Peripheral Neuropathy

Baseline characteristics by cohort

Measure	Salsalate n=8 Participants All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner). Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Age, Continuous	57.0 Years STANDARD_DEVIATION 5.7 • n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Type 1 diabetes with painful neuropathy

Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.

Outcome measures

Measure	Salsalate n=8 Participants All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner). Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm Baseline Thigh IENFD(fibers per mm)	6.3 fibers per mm Standard Deviation 5.4
Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm Baseline Ankle IENFD(fibers per mm)	3.0 fibers per mm Standard Deviation 3.3
Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm 12 Week Thigh IENFD(fibers per mm)	5.2 fibers per mm Standard Deviation 4.4
Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm 12 Week Ankle IENFD(fibers per mm)	3.0 fibers per mm Standard Deviation 3.5

Adverse Events

Salsalate

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Salsalate n=8 participants at risk All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner). Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Metabolism and nutrition disorders Severe Hypoglycemia	12.5% 1/8 • Number of events 1 • 3 months

Other adverse events

Measure	Salsalate n=8 participants at risk All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner). Salsalate: Salsalate 3 grams daily (1 gram TID with meals)
Ear and labyrinth disorders Tinnitus	37.5% 3/8 • Number of events 3 • 3 months
Respiratory, thoracic and mediastinal disorders Upper Respiratory Symptoms	25.0% 2/8 • Number of events 2 • 3 months
Surgical and medical procedures Increased Bleeding from Biopsy Site	12.5% 1/8 • Number of events 1 • 3 months
Endocrine disorders Hot Flashes	12.5% 1/8 • Number of events 1 • 3 months
Eye disorders Cataract Removal	12.5% 1/8 • Number of events 1 • 3 months
Skin and subcutaneous tissue disorders Skin Biopsy of Suspicious Lesion	12.5% 1/8 • Number of events 1 • 3 months

Additional Information

Rodica Pop-Busui, MD, PhD

The University of Michigan

Phone: 734-763-3056

Email: rpbusui@umich.edu

Results disclosure agreements

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