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

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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 ]
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Measure Type Primary
Measure Title The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.
Measure Description HbA1c (%, percentage of HbA1c) change from baseline.
Time Frame 48 weeks from baseline  
Safety Issue No  

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.
Participants with complete data at both Baseline and 48 weeks

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

Measured Values
    Placebo     Salsalate  
Number of Participants Analyzed  
[units: participants]
  137     146  
The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.  
[units: HbA1c units are %]
Mean ( 95% Confidence Interval )
  -0.04  
  ( -0.07 to 0.15 )  
  -0.33  
  ( -0.44 to -0.22 )  

No statistical analysis provided for The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.



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
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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