This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01698775
First received: October 1, 2012
Last updated: May 31, 2017
Last verified: May 2017
Results First Received: January 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Omarigliptin
Drug: Placebo to omarigliptin
Drug: Glipizide
Drug: Placebo to glipizide
Biological: Insulin

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

Participant Flow for 2 periods

Period 1:   Phase A
    Omarigliptin (Phase A) → Omarigliptin (Phase B)   Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
STARTED   107   106 
COMPLETED   98   97 
NOT COMPLETED   9   9 
Adverse Event                2                1 
Death                1                1 
Lack of Efficacy                1                0 
Lost to Follow-up                1                2 
Protocol Violation                1                0 
Withdrawal by Subject                3                4 
Kidney [transplant]                0                1 

Period 2:   Phase B
    Omarigliptin (Phase A) → Omarigliptin (Phase B)   Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)
STARTED   98   97 
COMPLETED   84   86 
NOT COMPLETED   14   11 
Hyperglycemia Discontinuation Criteria                0                1 
Adverse Event                6                3 
Death                0                1 
Lack of Efficacy                0                1 
Lost to Follow-up                0                1 
Physician Decision                1                1 
Protocol Violation                1                1 
Withdrawal by Subject                6                2 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Omarigliptin (Phase A) Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
Placebo to Omarigliptin (Phase A) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Omarigliptin (Phase A)   Placebo to Omarigliptin (Phase A)   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   106   213 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.9  (9.4)   64.5  (9.7)   65.2  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      39  36.4%      43  40.6%      82  38.5% 
Male      68  63.6%      63  59.4%      131  61.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)   [ Time Frame: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug) ]

3.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)   [ Time Frame: Up to 24 weeks ]

4.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)   [ Time Frame: Up to 58 weeks (including 28 days following the last dose of study therapy) ]

5.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)   [ Time Frame: Up to 54 weeks ]

6.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline in A1C at Week 54   [ Time Frame: Baseline and Week 54 ]

8.  Secondary:   Change From Baseline in FPG at Week 54   [ Time Frame: Baseline and Week 54 ]

9.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Change From Baseline in eGFR at Week 54   [ Time Frame: Baseline and Week 54 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: NCT01698775     History of Changes
Other Study ID Numbers: 3102-019
2012-002332-85 ( EudraCT Number )
Study First Received: October 1, 2012
Results First Received: January 3, 2017
Last Updated: May 31, 2017