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A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)

This study has been terminated.
(The study was terminated early by the Sponsor for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01477853
First received: November 19, 2011
Last updated: August 11, 2016
Last verified: August 2016
Results First Received: June 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin
Drug: Atorvastatin
Other: Placebo to sitagliptin
Other: Placebo to atorvastatin
Drug: Metformin (open-label)
Drug: Glimepiride (open-label)
Drug: Glimepiride (double-blind)
Drug: Placebo to glimepiride

  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
Note: 10 participants were enrolled in the study more than once (at more than 1 study site). Nine participants were enrolled twice and one participant was randomized at 3 different sites. Therefore, data of 10 actual participants (counted as 21 participants due to multiple screening/randomization) were removed from the efficacy analyses.

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/Sitagliptin + Atorvastatin In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
Atorvastatin/Atorvastatin + Glimepiride In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.

Participant Flow for 2 periods

Period 1:   Phase A
    Sitagliptin/Sitagliptin + Atorvastatin   Atorvastatin/Atorvastatin + Glimepiride   Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
STARTED   55   56   55 
COMPLETED   12   11   11 
NOT COMPLETED   43   45   44 
Adverse Event                1                2                2 
Lost to Follow-up                4                3                2 
Physician Decision                1                0                1 
Study terminated by sponsor                37                40                39 

Period 2:   Phase B
    Sitagliptin/Sitagliptin + Atorvastatin   Atorvastatin/Atorvastatin + Glimepiride   Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
STARTED   12   11   11 
COMPLETED   0   0   0 
NOT COMPLETED   12   11   11 
Lost to Follow-up                0                1                0 
Study terminated by sponsor                12                10                11 



  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 + Atorvastatin In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
Atorvastatin/Atorvastatin + Glimepiride In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
Total Total of all reporting groups

Baseline Measures
   Sitagliptin/Sitagliptin + Atorvastatin   Atorvastatin/Atorvastatin + Glimepiride   Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   56   55   166 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.2  (9.7)   56.3  (8.2)   53.7  (10.0)   55.4  (9.4) 
Gender 
[Units: Participants]
       
Female   24   27   24   75 
Male   31   29   31   91 


  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1C (A1C) at Week 16   [ Time Frame: Baseline and Week 16 ]

2.  Primary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16   [ Time Frame: Baseline and Week 16 ]

3.  Primary:   Number of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 56 weeks (including 2-week follow-up) ]

4.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 54 weeks ]

5.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16   [ Time Frame: Baseline and Week 16 ]

6.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 16   [ Time Frame: Baseline and Week 16 ]

7.  Secondary:   Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16   [ Time Frame: Baseline and Week 16 ]

8.  Secondary:   Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16   [ Time Frame: Baseline and Week 16 ]

9.  Secondary:   Percent Change From Baseline in Triglycerides at Week 16   [ Time Frame: Baseline and Week 16 ]

10.  Secondary:   Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16   [ Time Frame: Baseline and Week 16 ]

11.  Secondary:   Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16   [ Time Frame: Baseline and Week 16 ]


  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
The study was terminated early by the Sponsor for business reasons. Due to the small number of participants included in the FAS, the results for Phase A and for the overall study should be interpreted with caution.


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01477853     History of Changes
Other Study ID Numbers: 0431E-211
2011-003600-20 ( EudraCT Number )
Study First Received: November 19, 2011
Results First Received: June 21, 2016
Last Updated: August 11, 2016
Health Authority: United States: Food and Drug Administration