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Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036515
First Posted: January 15, 2014
Last Update Posted: July 24, 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: May 19, 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 15 mg
Drug: Placebo for ertugliflozin 5 mg
Drug: Metformin
Drug: Sitagliptin
Drug: Glimepiride
Biological: Insulin
Drug: Placebo for ertugliflozin 10 mg

  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
Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Participant Flow:   Overall Study
    Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo
STARTED   156   155   153 
Treated   156   153   153 
COMPLETED   151   143   139 
NOT COMPLETED   5   12   14 
Adverse Event                1                1                2 
Lost to Follow-up                0                2                0 
Non-compliance with study drug                0                0                2 
Screen failure                0                2                0 
Withdrawal by Subject                4                7                9 
Hyperglycemia                0                0                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 as treated population excludes two participants randomized to Ertugliflozin 15 mg but did not receive any treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   153   153   462 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (9.3)   59.7  (8.6)   58.3  (9.2)   59.1  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      75  48.1%      71  46.4%      53  34.6%      199  43.1% 
Male      81  51.9%      82  53.6%      100  65.4%      263  56.9% 
Hemoglobin A1c (A1C) [1] 
[Units: Percent]
Mean (Standard Deviation)
 8.05  (0.86)   8.00  (0.83)   8.03  (0.93)   8.03  (0.88) 
[1] Participants with baseline data: ertugliflozin 5 mg, n=155; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=459
Fasting plasma glucose [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 167.7  (37.7)   171.7  (39.1)   169.6  (37.8)   169.7  (38.2) 
[1] Participants with baseline data: ertugliflozin 5 mg, n=156; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=460
Body weight 
[Units: Kilograms]
Mean (Standard Deviation)
 87.6  (18.6)   86.6  (19.5)   86.4  (20.8)   86.9  (19.6) 
Estimated glomerular filtration rate (eGFR) 
[Units: mL/min/1.73m^2]
Mean (Standard Deviation)
 87.0  (17.5)   86.9  (15.6)   89.9  (17.5)   87.9  (16.9) 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Percentage of Participants Experiencing An Adverse Event (AE)   [ Time Frame: Up to Week 54 ]

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

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (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 an A1C <7% (53 mmol/Mol) at Week 26   [ Time Frame: Week 26 ]

7.  Secondary:   Change From Baseline in Sitting Systolic Blood Pressure at Week 26   [ Time Frame: Baseline and Week 26 ]

8.  Secondary:   Change From Baseline in Hemoglobin A1C at Week 52   [ Time Frame: Baseline and Week 52 ]

9.  Secondary:   Change From Baseline in FPG at Week 52   [ Time Frame: Baseline and Week 52 ]

10.  Secondary:   Change From Baseline in Body Weight at Week 52   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52   [ Time Frame: Week 52 ]

12.  Secondary:   Change From Baseline in Sitting Systolic Blood Pressure at Week 52   [ Time Frame: Baseline and Week 52 ]

13.  Secondary:   Change From Baseline in Sitting Diastolic Blood Pressure at Week 26   [ Time Frame: Baseline and Week 26 ]

14.  Secondary:   Change From Baseline in Sitting Diastolic Blood Pressure at Week 52   [ Time Frame: Baseline and Week 52 ]

15.  Secondary:   Percentage of Participants Receiving Glycemic Rescue Medication by Week 26   [ Time Frame: Week 26 ]

16.  Secondary:   Percentage of Participants Receiving Glycemic Rescue Medication by Week 52   [ Time Frame: Week 52 ]

17.  Secondary:   Time to Initiation of Glycemic Rescue by Week 26   [ Time Frame: Up to Week 26 (plus 30 days for 1 placebo participant) ]

18.  Secondary:   Time to Initiation of Glycemic Rescue by Week 52   [ Time Frame: Up to week 52 ]

19.  Secondary:   Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value   [ Time Frame: Baseline ]

20.  Secondary:   Change From Baseline in HOMA-%β at Week 26   [ Time Frame: Baseline and Week 26 ]

21.  Secondary:   Change From Baseline in HOMA-%β at Week 52   [ Time Frame: Baseline and Week 52 ]

22.  Secondary:   Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score   [ Time Frame: Baseline ]

23.  Secondary:   Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26   [ Time Frame: Baseline and Week 26 ]

24.  Secondary:   Change From Baseline in EQ-5D-3L Score at Week 52   [ Time Frame: Baseline and Week 52 ]


  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 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: NCT02036515     History of Changes
Other Study ID Numbers: 8835-006
2013-003697-26 ( EudraCT Number )
B1521015 ( Other Identifier: Pfizer Study Number )
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: May 19, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017