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Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00392678
First received: October 25, 2006
Last updated: July 25, 2013
Last verified: July 2013
Results First Received: February 20, 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
Interventions: Drug: Salsalate
Drug: 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
3 private practices and 14 universities. First patient recruited February 2007; last patient end of study visit, May 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening, followed by 4-week single mask placebo lead-in. 277 participants signed screening consent. Some participants were ineligible, some withdrew consent, and some had treatment side effects during placebo lead-in.

Reporting Groups
  Description
Salsalate 3.0 g/d No text entered.
Salsalate 3.5 g/d No text entered.
Salsalate 4.0 g/d No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Salsalate 3.0 g/d     Salsalate 3.5 g/d     Salsalate 4.0 g/d     Placebo  
STARTED     27     27     27     27  
COMPLETED     27     26     25     26  
NOT COMPLETED     0     1     2     1  



  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
Salsalate 3.0 g/d No text entered.
Salsalate 3.5 g/d No text entered.
Salsalate 4.0 g/d No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Salsalate 3.0 g/d     Salsalate 3.5 g/d     Salsalate 4.0 g/d     Placebo     Total  
Number of Participants  
[units: participants]
  27     27     27     27     108  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     23     22     24     22     91  
>=65 years     4     5     3     5     17  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 9.4     56.7  ± 9.8     55.0  ± 10.2     55.9  ± 8.2     56  ± 9  
Gender  
[units: participants]
         
Female     13     9     11     12     45  
Male     14     18     16     15     63  
Region of Enrollment  
[units: participants]
         
United States     27     27     27     27     108  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 14 (Stage 1) in the Intent-to-treat (ITT) Population With Last Observation Carried Forward.   [ Time Frame: 14 week ]

2.  Secondary:   Change From Baseline to Either 14 or 26 Weeks, or Last HbA1c Measurement Prior to Rescue Therapy   [ Time Frame: 14 week ]

3.  Secondary:   Change From Baseline and Trends in Fasting Glucose Over Time   [ Time Frame: 14 week ]

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: 14 week ]

5.  Secondary:   Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index   [ Time Frame: Baseline, week 14 ]

6.  Secondary:   Safety and Tolerability of Salsalate Compared to Placebo as Assessed by Adverse Events.   [ Time Frame: 14 weeks ]

7.  Secondary:   Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index   [ Time Frame: Baseline, week 14 ]

8.  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: 14-26 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups   [ Time Frame: 14 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Need for Rescue Therapy   [ Time Frame: 14 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Need for Discontinuation of Study Medication   [ Time Frame: 14 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy   [ Time Frame: 14-26 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Response Rates for a Reduction in HbA1c for Obese vs Non-obese Participants   [ Time Frame: 14-26 week ]
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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Allison B. Goldfine, MD co-investigator
Organization: Joslin Diabetes Center
phone: 617-309-2643
e-mail: allison.goldfine@joslin.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00392678     History of Changes
Other Study ID Numbers: CHS 06-20, NIH U01 DK74556, U01DK074556
Study First Received: October 25, 2006
Results First Received: February 20, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government