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Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

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ClinicalTrials.gov Identifier: NCT01096667
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Hypertension
Interventions: Drug: Placebo to Ertuglilflozin 1 or 5 mg
Drug: Ertugliflozin 1 mg
Drug: Ertugliflozin 5 mg
Drug: Ertugliflozin 25 mg
Drug: HCTZ 12.5mg
Drug: Placebo to HCTZ
Drug: Placebo to ertuglilflozin 25 mg

  Participant Flow

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
Prior to randomization, 194 participants received placebo for at least 3 weeks (completed the run-in period). Treated participants included all randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
Placebo Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to hydrochlorothiazide (HCTZ), once daily for 28 days.
Ertugliflozin 1 mg Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Ertugliflozin 5 mg Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
HCTZ 12.5mg HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days

Participant Flow:   Overall Study
    Placebo   Ertugliflozin 1 mg   Ertugliflozin 5 mg   Ertugliflozin 25 mg   HCTZ 12.5mg
STARTED   39   39   38   39   39 
Treated   38   39   38   39   39 
COMPLETED   36   37   36   36   39 
NOT COMPLETED   3   2   2   3   0 
Lost to Follow-up                1                1                1                0                0 
Withdrawal by Subject                1                0                0                1                0 
Reason not available                0                1                1                1                0 
Protocol Violation                0                0                0                1                0 
Not treated                1                0                0                0                0 



  Baseline Characteristics

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.
Baseline analysis population includes participants who received at least 1 dose of blinded treatment regimen.

Reporting Groups
  Description
Placebo Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
Ertugliflozin 1 mg Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Ertugliflozin 5 mg Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
HCTZ 12.5mg HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
Total Total of all reporting groups

Baseline Measures
   Placebo   Ertugliflozin 1 mg   Ertugliflozin 5 mg   Ertugliflozin 25 mg   HCTZ 12.5mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 38   39   38   39   39   193 
Age, Customized 
[Units: Participants]
 		           
<18 years   0   0   0   0   0   0 
Between 18 and 44 years   3   4   3   5   1   16 
Between 45 and 64 years   34   34   32   34   34   168 
65 years and older   1   1   3   0   4   9 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		           
Female      14  36.8%      12  30.8%      13  34.2%      12  30.8%      11  28.2%      62  32.1% 
Male      24  63.2%      27  69.2%      25  65.8%      27  69.2%      28  71.8%      131  67.9% 


  Outcome Measures

1.  Primary:   Baseline 24-hour Average Systolic Blood Pressure (SBP)   [ Time Frame: 24 hours ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline on 24-hour Average SBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 2

3.  Secondary:   Baseline Average Daytime and Nighttime SBP   [ Time Frame: Daytime: 16 hours; Nighttime: 8 hours ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline on Daytime Average SBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline on Nighttime Average SBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 5

6.  Secondary:   Baseline Seated, Triplicate Trough SBP   [ Time Frame: Baseline ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Seated, Triplicate Trough SBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 7

8.  Secondary:   Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)   [ Time Frame: up to 24 hours ]
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9.  Secondary:   Change From Baseline on 24-hour Average DBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline on Daytime Average DBP at Week 4   [ Time Frame: Baseline and Week 4 ]
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11.  Secondary:   Change From Baseline on Nighttime Average DBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 11

12.  Secondary:   Baseline Seated, Triplicate Trough DBP   [ Time Frame: Baseline ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in Seated, Triplicate Trough DBP at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 13

14.  Secondary:   Baseline 24-hour, Daytime and Nightime Average Heart Rate   [ Time Frame: up to 24 hours ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline on 24-hour Average Heart Rate at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline on Daytime Average Heart Rate at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline on Nighttime Average Heart Rate at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 17

18.  Secondary:   Baseline Seated, Triplicate Trough Heart Rate   [ Time Frame: Baseline ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 19

20.  Secondary:   Baseline 24-hour Average Urinary Glucose Excretion   [ Time Frame: 24 hours ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 21

22.  Secondary:   Baseline Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline ]
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23.  Secondary:   Change From Baseline in FPG at Week 4   [ Time Frame: Baseline and Week 4 ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in FPG at Week 2   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 24

25.  Secondary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to 63 days (including run-in, treatment period, and follow-up) ]
  Show Outcome Measure 25

26.  Secondary:   Number of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to 28 days (treatment period) ]
  Show Outcome Measure 26


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: NCT01096667     History of Changes
Other Study ID Numbers: 8835-042
B1521004 ( Other Identifier: Pfizer protocol number )
MK-8835-042 ( Other Identifier: Merck Protocol Number )
First Submitted: March 26, 2010
First Posted: March 31, 2010
Results First Submitted: November 15, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017