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A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01755156
First received: December 18, 2012
Last updated: March 23, 2017
Last verified: March 2017
Results First Received: January 30, 2017  
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: Matching placebo to omarigliptin
Drug: Glimepiride
Drug: Matching placebo to glimepiride
Drug: Insulin glargine
Drug: Metformin

  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
No text entered.

Reporting Groups
  Description
Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.

Participant Flow for 2 periods

Period 1:   Phase A (Weeks 0-24)
    Omarigliptin (Phase A) → Omarigliptin (Phase B)   Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)
STARTED   201   201 
COMPLETED   184   177 
NOT COMPLETED   17   24 
Adverse Event                2                3 
Lack of Efficacy                1                0 
Lost to Follow-up                5                3 
Non-compliance with study drug                1                0 
Physician Decision                0                1 
Protocol Violation                1                1 
Withdrawal by Subject                6                13 
Creatinine or eGFR Discon. Criteria                0                2 
Need for Excluded Med. Discon. Criteria                1                1 

Period 2:   Phase B (Weeks 24-104)
    Omarigliptin (Phase A) → Omarigliptin (Phase B)   Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)
STARTED   183 [1]   177 
COMPLETED   144   141 
NOT COMPLETED   39   36 
Lost to Follow-up                12                5 
Withdrawal by Subject                27                31 
[1] 1 participant who completed Phase A did not continue to Phase B.



  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
Omarigliptin (Phase A) Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
Placebo to Omarigliptin (Phase A) Phase A: Matching placebo to omarigliptin capsule administered orally once weekly 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]
 201   201   402 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (8.1)   56.8  (9.1)   57.2  (8.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      100  49.8%      99  49.3%      199  49.5% 
Male      101  50.2%      102  50.7%      203  50.5% 
Hemoglobin A1C (A1C) 
[Units: Percent]
Mean (Standard Deviation)
 8.06  (0.87)   8.02  (0.89)   8.04  (0.88) 
2-hour post-meal glucose (2-hr PMG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 240.2  (60.5)   236.0  (59.9)   238.1  (60.2) 
[1] Omarigliptin (Phase A), n=192; Placebo to omarigliptin (Phase A), n=193; Total, n=385
Fasting plasma glucose (FPG) 
[Units: mg/dL]
Mean (Standard Deviation)
 168.8  (37.6)   168.6  (37.2)   168.7  (37.4) 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)   [ Time Frame: Up to 107 weeks ]

3.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)   [ Time Frame: Up to 104 weeks ]

4.  Primary:   Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)   [ Time Frame: Up to 104 weeks ]

5.  Secondary:   Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)   [ Time Frame: Baseline and Week 24 ]

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

7.  Secondary:   Change From Baseline in A1C at Week 104 (Phase A+B)   [ Time Frame: Baseline and Week 104 ]

8.  Secondary:   Change From Baseline in FPG at Week 104 (Phase A+B)   [ Time Frame: Baseline and Week 104 ]

9.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)   [ Time Frame: 24 weeks ]

10.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)   [ Time Frame: 24 weeks ]

11.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)   [ Time Frame: 104 weeks ]

12.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)   [ Time Frame: 104 weeks ]

13.  Secondary:   Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   Change From Baseline in Fasting Insulin at Week 24 (Phase A)   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:   Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)   [ Time Frame: Baseline and Week 104 ]

16.  Secondary:   Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)   [ Time Frame: Up to 24 weeks ]

17.  Secondary:   Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)   [ Time Frame: Up to 104 weeks ]

18.  Secondary:   Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)   [ Time Frame: Up to 24 weeks ]

19.  Secondary:   Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)   [ Time Frame: Up to 104 weeks ]


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01755156     History of Changes
Other Study ID Numbers: 3102-024
2012-003670-11 ( EudraCT Number )
Study First Received: December 18, 2012
Results First Received: January 30, 2017
Last Updated: March 23, 2017