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A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01958671
First Posted: October 9, 2013
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: July 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Ertugliflozin 5 mg
Drug: Ertugliflozin 10 mg
Drug: Placebo to Ertugliflozin
Drug: Metformin
Drug: Placebo to Metformin
Drug: 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
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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
Ertugliflozin 5 mg/Ertugliflozin 5 mg Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Ertugliflozin 15 mg/Ertugliflozin 15 mg Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Placebo/Metformin Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.

Participant Flow:   Overall Study
    Ertugliflozin 5 mg/Ertugliflozin 5 mg   Ertugliflozin 15 mg/Ertugliflozin 15 mg   Placebo/Metformin
STARTED   156   152   153 
COMPLETED   137   128   121 
NOT COMPLETED   19   24   32 
Adverse Event                1                1                5 
Death                1                0                0 
Excluded medication                0                0                1 
Hyperglycemia                0                0                2 
Lost to Follow-up                7                11                7 
Non-compliance with study drug                1                1                1 
Pregnancy                0                0                1 
Protocol Violation                0                1                0 
Study site terminated by sponsor                1                0                1 
Participant moved                0                0                1 
Withdrawal by Subject                8                10                13 



  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
Ertugliflozin 5 mg/Ertugliflozin 5 mg Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Ertugliflozin 15 mg/Ertugliflozin 15 mg Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Placebo/Metformin Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Total Total of all reporting groups

Baseline Measures
   Ertugliflozin 5 mg/Ertugliflozin 5 mg   Ertugliflozin 15 mg/Ertugliflozin 15 mg   Placebo/Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   152   153   461 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 156   152   153   461 
   56.8  (11.4)   56.2  (10.8)   56.1  (10.9)   56.4  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 156   152   153   461 
Female      67  42.9%      62  40.8%      71  46.4%      200  43.4% 
Male      89  57.1%      90  59.2%      82  53.6%      261  56.6% 
Hemoglobin A1c (A1C) [1] 
[Units: Percent]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 155   151   153   459 
   8.16  (0.88)   8.35  (1.12)   8.11  (0.92)   8.21  (0.98) 
[1] All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
Fasting plasma glucose (FPG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 151   149   150   450 
   180.9  (48.5)   179.1  (48.2)   180.2  (45.8)   180.1  (47.4) 
[1] All randomized participants who received at least 1 dose of study treatment and had baseline FPG measurement.
Estimated glomerular filtration rate (eGFR) 
[Units: mL/min/1.75m^2]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 156   152   153   461 
   88.5  (18.4)   88.3  (18.0)   86.2  (19.4)   87.7  (18.6) 
Body weight 
[Units: Kilograms]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 156   152   153   461 
   94.0  (25.4)   90.6  (18.3)   94.2  (25.2)   92.9  (23.2) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline In A1C at Week 26   [ Time Frame: Baseline and Week 26 ]

2.  Primary:   Percentage of Participants Experiencing An Adverse Event (AE)   [ Time Frame: Up to 54 weeks (including 2 weeks following last dose) ]

3.  Primary:   Percentage of Participants Discontinuing Study Treatment Due to an AE   [ Time Frame: Up to 52 weeks ]

4.  Secondary:   Change From Baseline in FPG at Week 26   [ Time Frame: Baseline and Week 26 ]

5.  Secondary:   Change From Baseline in Body Weight at Week 26   [ Time Frame: Baseline and Week 26 ]

6.  Secondary:   Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26   [ Time Frame: Week 26 ]

7.  Secondary:   Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level   [ Time Frame: Baseline ]

8.  Secondary:   Change From Baseline in 2-hr PPG at Week 26   [ Time Frame: Baseline and Week 26 ]

9.  Secondary:   Baseline Sitting Systolic Blood Pressure (SBP)   [ Time Frame: Baseline ]

10.  Secondary:   Change From Baseline in SBP at Week 26   [ Time Frame: Baseline and Week 26 ]

11.  Secondary:   Baseline Sitting Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline ]

12.  Secondary:   Change From Baseline in DBP at Week 26   [ Time Frame: Baseline and Week 26 ]


  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: NCT01958671     History of Changes
Other Study ID Numbers: 8835-003
2013-002519-90 ( EudraCT Number )
B1521022 ( Other Identifier: Pfizer Protocol Number )
First Submitted: October 7, 2013
First Posted: October 9, 2013
Results First Submitted: July 14, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017