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Targeting Inflammation Using Salsalate for Type 2 Diabetes-stage II (TINSAL-T2D-II)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00799643
First received: November 26, 2008
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: September 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Salsalate
Drug: Salsalate Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Placebo for salsalate, orally, divided dosing
Salsalate Salsalate, 3.5 g/d orally,divided dosing

Participant Flow:   Overall Study
    Placebo   Salsalate
STARTED   140   146 
COMPLETED   115   119 
NOT COMPLETED   25   27 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo for salsalate, orally, divided dosing
Salsalate Salsalate, 3.5 g/d orally, divided dosing
Total Total of all reporting groups

Baseline Measures
   Placebo   Salsalate   Total 
Overall Participants Analyzed 
[Units: Participants]
 140   146   286 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   112   118   230 
>=65 years   28   28   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.8  (10)   55.8  (9.2)   55.8  (9.6) 
Gender 
[Units: Participants]
     
Female   65   64   129 
Male   75   82   157 
Region of Enrollment 
[Units: Participants]
     
United States   140   146   286 


  Outcome Measures
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1.  Primary:   The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.   [ Time Frame: 48 weeks from baseline ]

2.  Secondary:   Change From Baseline in Fasting Glucose Over Time.   [ Time Frame: 48 weeks from baseline ]

3.  Secondary:   Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information