A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)

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ClinicalTrials.gov Identifier: NCT01703208

Recruitment Status : Terminated (The study was terminated for business reasons and not due to any safety or efficacy concerns related to omarigliptin)

First Posted : October 10, 2012

Results First Posted : December 12, 2017

Last Update Posted : December 12, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: Omarigliptin Drug: Placebo

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
A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant. An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant.

An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
On April 8, 2016, Merck & Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016. Due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.

Reporting Groups

	Description
Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Participant Flow: Overall Study

	Omarigliptin 25 mg	Placebo
STARTED	2100	2102
Treated	2092	2100
COMPLETED	0	0
NOT COMPLETED	2100	2102
Death	61	48
Lack of Efficacy	1	2
Lost to Follow-up	68	62
Non-Compliance with Study Drug	1	0
Excluded Medication	1	2
Site Discontinued Study Participation	23	27
Physician Decision	11	13
Progressive disease	2	2
Protocol Violation	1	1
Study Terminated by Sponsor	1710	1716
Withdrawal by Subject	205	209
Adverse Event	14	19
Technical Problems	0	1
Protocol Deviation	2	0

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.
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Reporting Groups

	Description
Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.
Total	Total of all reporting groups

Baseline Measures

Omarigliptin 25 mg

Placebo

Total

Overall Participants Analyzed
[Units: Participants]

2100

2102

4202

Age
[Units: Years]
Mean (Standard Deviation)

63.7 (8.5)

63.6 (8.5)

Sex: Female, Male
[Units: Participants]
Count of Participants

Female

639 30.4%

615 29.3%

1254 29.8%

Male

1461 69.6%

1487 70.7%

2948 70.2%

Hemoglobin A1C % ^[1]
[Units: Percent]
Mean (Standard Deviation)

7.99 (0.86)

8.03 (0.89)

8.01 (0.87)

^[1]	Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).

Fasting Plasma Glucose (FPG)
[Units: mg/dL]
Mean (Standard Deviation)

184.1 (52.2)

179.5 (45.7)

180.4 (47.8)

Outcome Measures

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1. Primary:

Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) [ Time Frame: Up to 156 weeks ]

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2. Primary:

Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) [ Time Frame: Up to 179 weeks ]

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3. Primary:

Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) [ Time Frame: Up to 179 weeks ]

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4. Primary:

Change From Baseline in Hemoglobin A1C (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ]

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5. Primary:

Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) [ Time Frame: Baseline and Week 18 ]

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6. Primary:

Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change [ Time Frame: Up to Week 18 ]

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7. Primary:

Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change [ Time Frame: Up to Week 18 ]

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8. Secondary:

Number of Participants With an Event of CV-Related Death [ Time Frame: Up to 179 weeks ]

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9. Secondary:

Number of Participants With an Event Per 100 Person-Years of CV-Related Death [ Time Frame: Up to 179 weeks ]

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10. Secondary:

Number of Participants With an Event of First MI (Fatal and Non-fatal) [ Time Frame: Up to 179 weeks ]

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11. Secondary:

Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal) [ Time Frame: Up to 179 weeks ]

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12. Secondary:

Number of Participants With an Event of Stroke (Fatal and Non-fatal) [ Time Frame: Up to 179 weeks ]

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13. Secondary:

Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal) [ Time Frame: Up to 179 weeks ]

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14. Secondary:

Number of Participants With an Event of All-Cause Death [ Time Frame: Up to 179 weeks ]

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15. Secondary:

Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death [ Time Frame: Up to 179 weeks ]

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16. Secondary:

Change From Baseline in A1C at Week 142 [ Time Frame: Baseline and Week 142 ]

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17. Secondary:

Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months [ Time Frame: 4 months ]

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18. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months [ Time Frame: Baseline and 4 months ]

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19. Secondary:

Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline [ Time Frame: Up to 179 weeks ]

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20. Secondary:

Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 234 weeks ]

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21. Secondary:

Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event [ Time Frame: Up to 212 weeks ]

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22. Secondary:

Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin [ Time Frame: Baseline and Week 18 ]

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23. Secondary:

Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin [ Time Frame: 18 weeks ]

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24. Other Pre-specified:

Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory) [ Time Frame: Up to 179 weeks ]

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25. Other Pre-specified:

Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory) [ Time Frame: Up to 179 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

Results Point of Contact:

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialDisclosure@merck.com

Publications of Results:

Gantz I, Chen M, Suryawanshi S, Ntabadde C, Shah S, O'Neill EA, Engel SS, Kaufman KD, Lai E. A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2017 Sep 11;16(1):112. doi: 10.1186/s12933-017-0593-8.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01703208 History of Changes
Other Study ID Numbers:	3102-018 2012-002414-39 ( EudraCT Number ) MK-3102-018 ( Other Identifier: Merck study number )
First Submitted:	October 5, 2012
First Posted:	October 10, 2012
Results First Submitted:	November 13, 2017
Results First Posted:	December 12, 2017
Last Update Posted:	December 12, 2017

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