A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01702298
First received: October 4, 2012
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC
Drug: Metformin

  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
No text entered.

Reporting Groups
  Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Participant Flow:   Overall Study
    Sitagliptin 100 mg/Simvastatin 40 mg FDC  
STARTED     42  
COMPLETED     41  
NOT COMPLETED     1  
Withdrawal by Subject                 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.
All participants enrolled

Reporting Groups
  Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Baseline Measures
    Sitagliptin 100 mg/Simvastatin 40 mg FDC  
Number of Participants  
[units: participants]
  42  
Age  
[units: Years]
Mean ± Standard Deviation
  48.3  ± 7.1  
Gender  
[units: Participants]
 
Female     19  
Male     23  
Fasting Plasma Glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  159.3  ± 40.9  
Low-density lipoprotein cholesterol (LDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  109.6  ± 27.2  
Total Cholesterol (TC)  
[units: md/dL]
Mean ± Standard Deviation
  195.2  ± 36.4  
(Non-High-Density Lipoprotein Cholesterol (non-HDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  152.0  ± 37.9  
Triglycerides (TG)  
[units: mg/dL]
Mean ± Standard Deviation
  225.3  ± 152.5  
High-Density Lipoprotein Cholesterol (HDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  43.1  ± 11.9  



  Outcome Measures
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1.  Primary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline and Week 6 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 8 weeks (including 14 days after final dose of study drug) ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 6 weeks ]

4.  Secondary:   Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   Change From Baseline in Total Cholesterol (TC)   [ Time Frame: Baseline and Week 6 ]

6.  Secondary:   Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)   [ Time Frame: Baseline and Week 6 ]

7.  Secondary:   Change From Baseline in Triglycerides (TG)   [ Time Frame: Baseline and Week 6 ]

8.  Secondary:   Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline and Week 6 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to 8 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Other Adverse Events
    Sitagliptin 100 mg/Simvastatin 40 mg FDC  
Total, other (not including serious) adverse events    
# participants affected / at risk     3/42  
Metabolism and nutrition disorders    
Hypoglycemia † 1  
# participants affected / at risk     3/42 (7.14%)  
# events     4  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 16.0



  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01702298     History of Changes
Other Study ID Numbers: 0431D-312
Study First Received: October 4, 2012
Results First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: Vietnam: Ministry of Health