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Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) (TECOS)

This study has been completed.
Sponsor:
Collaborator:
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00790205
First received: November 11, 2008
Last updated: May 20, 2016
Last verified: May 2016
Results First Received: March 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 14,671 participants were randomized to treatment, provided consent and did not have any Good Clinical Practice (GCP) deviations.

Reporting Groups
  Description
Sitagliptin Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
Placebo Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years

Participant Flow:   Overall Study
    Sitagliptin     Placebo  
STARTED     7332     7339  
Treated     7266     7274  
COMPLETED     6972     6905  
NOT COMPLETED     360     434  
Lost to Follow-up                 61                 71  
Withdrawal by Subject                 299                 363  



  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
Sitagliptin Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
Placebo Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Placebo     Total  
Number of Participants  
[units: participants]
  7332     7339     14671  
Age, Customized [1]
[units: Participants]
     
Adults 18 - 64 years     3315     3301     6616  
From 65 - 84 years     3813     3821     7634  
85 years and over     46     55     101  
Unknown age     158     162     320  
Gender  
[units: Participants]
     
Female     2134     2163     4297  
Male     5198     5176     10374  
Estimated Glomerular Filtration Rate (eGFR) [2]
[units: mL/min/1.73 m^2]
Mean (Standard Deviation)
  74.9  (21.3)     74.9  (20.9)     74.9  (21.1)  
Hemoglobin A1c (HbA1c) [3]
[units: Percentage of HbA1c]
Mean (Standard Deviation)
  7.2  (0.5)     7.2  (0.5)     7.2  (0.5)  
Urine albumin creatinine ratio [4]
[units: g/mol Creatinine]
Mean (Standard Deviation)
  8.6  (37.4)     8.4  (36.0)     8.5  (36.7)  
[1] Age is unknown for 320 participants
[2] Sitagliptin, n= 7254; Placebo, n= 7274; Total, n=14528
[3] Sitagliptin, n= 7330; Placebo, n= 7336; Total, n= 14666
[4] Sitagliptin, n= 2606; Placebo, n= 2542; Total, n= 5148



  Outcome Measures
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1.  Primary:   Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)   [ Time Frame: Up to 5 years ]

2.  Primary:   Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)   [ Time Frame: Up to 5 years ]

5.  Secondary:   Percent Incidence of All-cause Mortality (Per Protocol Population)   [ Time Frame: Up to 5 years ]

6.  Secondary:   Percent Incidence of All-cause Mortality (Intent to Treat Population)   [ Time Frame: Up to 5 years ]

7.  Secondary:   Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)   [ Time Frame: Up to 5 years ]

8.  Secondary:   Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)   [ Time Frame: Up to 5 years ]

9.  Secondary:   Change From Baseline in Renal Function Over Time (Per Protocol Population)   [ Time Frame: Baseline and up to 5 years ]

10.  Secondary:   Change From Baseline in Renal Function Over Time (Intent to Treat Population)   [ Time Frame: Baseline and up to 5 years ]

11.  Secondary:   Change From Baseline in HbA1c Over Time (Per Protocol Population)   [ Time Frame: Baseline and up to 4 years ]

12.  Secondary:   Change From Baseline in HbA1c Over Time (Intent to Treat Population)   [ Time Frame: Baseline and up to 4 years ]

13.  Secondary:   Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)   [ Time Frame: Baseline and up to 5 years ]

14.  Secondary:   Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)   [ Time Frame: Baseline and up to 5 years ]

15.  Secondary:   Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)   [ Time Frame: Up to 5 years ]

16.  Secondary:   Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)   [ Time Frame: Up to 5 years ]

17.  Secondary:   Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)   [ Time Frame: Up to 5 years ]

18.  Secondary:   Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)   [ Time Frame: Up to 5 years ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00790205     History of Changes
Other Study ID Numbers: 0431-082
2008_523 ( Other Identifier: Merck study number )
2008-006719-20 ( EudraCT Number )
Study First Received: November 11, 2008
Results First Received: March 15, 2016
Last Updated: May 20, 2016
Health Authority: United States: Food and Drug Administration