Trial Outcomes & Findings for Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II (NCT NCT00799643)
NCT ID: NCT00799643
Last Updated: 2017-12-11
Results Overview
HbA1c (%, percentage of HbA1c) change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
638 participants
Primary outcome timeframe
48 weeks from baseline
Results posted on
2017-12-11
Participant Flow
The Enrollment number in the protocol section (638) is higher than the number of participants Started in the Participant Flow module (286) due to screen failures and drop out prior to randomization.
Participant milestones
| Measure |
Placebo
Placebo for salsalate, orally, divided dosing
|
Salsalate
Salsalate, 3.5 g/d orally,divided dosing
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
146
|
|
Overall Study
COMPLETED
|
115
|
119
|
|
Overall Study
NOT COMPLETED
|
25
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II
Baseline characteristics by cohort
| Measure |
Placebo
n=140 Participants
Placebo for salsalate, orally, divided dosing
|
Salsalate
n=146 Participants
Salsalate, 3.5 g/d orally, divided dosing
|
Total
n=286 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
|
112 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 10 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=5 Participants
|
146 participants
n=7 Participants
|
286 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeks from baselinePopulation: Participants with complete data at both Baseline and 48 weeks
HbA1c (%, percentage of HbA1c) change from baseline.
Outcome measures
| Measure |
Placebo
n=137 Participants
Placebo for salsalate, orally, divided dosing
|
Salsalate
n=146 Participants
Salsalate, 3.5 g/d orally, divided dosing
|
|---|---|---|
|
The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.
|
-0.04 HbA1c units are %
Interval -0.07 to 0.15
|
-0.33 HbA1c units are %
Interval -0.44 to -0.22
|
SECONDARY outcome
Timeframe: 48 weeks from baselinePopulation: Participants with complete data at both Baseline and 48 weeks
Outcome measures
| Measure |
Placebo
n=137 Participants
Placebo for salsalate, orally, divided dosing
|
Salsalate
n=146 Participants
Salsalate, 3.5 g/d orally, divided dosing
|
|---|---|---|
|
Change From Baseline in Fasting Glucose Over Time.
|
2.0 mg/dl
Interval -1.9 to 5.9
|
-13.1 mg/dl
Interval -16.9 to -9.2
|
SECONDARY outcome
Timeframe: 24 and 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 and 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 and 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 and 48 weeksOutcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 64 other events
Deaths: 0 deaths
Salsalate
Serious events: 10 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=140 participants at risk
Placebo for salsalate, orally, divided dosing
|
Salsalate
n=146 participants at risk
Salsalate, 3.5 g/d orally,divided dosing
|
|---|---|---|
|
Renal and urinary disorders
Hematuria/Bladder Cancer
|
0.00%
0/140 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Benign Prostate Hypertrophy/TURP
|
0.71%
1/140 • Number of events 1 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
|
Blood and lymphatic system disorders
Chronic Lymphoid Leukemia
|
0.71%
1/140 • Number of events 1 • 48 weeks
|
0.00%
0/146 • 48 weeks
|
|
Hepatobiliary disorders
Gallstones/Cholycystectomy
|
0.00%
0/140 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/140 • 48 weeks
|
1.4%
2/146 • Number of events 2 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Reactive Airway Disease
|
0.71%
1/140 • Number of events 1 • 48 weeks
|
0.00%
0/146 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Degenerative Joint Disease
|
0.00%
0/140 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/140 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Traumatic Fracture or Joint Diastasis
|
0.00%
0/140 • 48 weeks
|
1.4%
2/146 • Number of events 2 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.4%
2/140 • Number of events 2 • 48 weeks
|
0.00%
0/146 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervical Disectomy
|
0.71%
1/140 • Number of events 1 • 48 weeks
|
0.00%
0/146 • 48 weeks
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.00%
0/140 • 48 weeks
|
0.68%
1/146 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Placebo
n=140 participants at risk
Placebo for salsalate, orally, divided dosing
|
Salsalate
n=146 participants at risk
Salsalate, 3.5 g/d orally,divided dosing
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
7/140 • 48 weeks
|
11.0%
16/146 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
19/140 • 48 weeks
|
13.7%
20/146 • 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
10/140 • 48 weeks
|
7.5%
11/146 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Stiffness
|
6.4%
9/140 • 48 weeks
|
9.6%
14/146 • 48 weeks
|
|
General disorders
Dizzy
|
7.1%
10/140 • 48 weeks
|
7.5%
11/146 • 48 weeks
|
|
General disorders
Weakness or Fatigue
|
6.4%
9/140 • 48 weeks
|
8.9%
13/146 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place