Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01697592
First received: September 28, 2012
Last updated: September 29, 2015
Last verified: September 2015
Results First Received: September 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Omarigliptin
Drug: Matching placebo to omarigliptin

  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
Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.

Reporting Groups
  Description
Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
Omarigliptin 25 mg/Glinides (Gln.) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln. throughout the duration of the study.
Omarigliptin 25 mg/Biguanides (BG) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
Omarigliptin 25 mg/α-GI (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
Placebo/SU (Phase A) → Omarigliptin 25 mg/SU (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
Placebo/Gln. (Phase A) → Omarigliptin 25 mg/Gln. (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
Placebo/BG (Phase A) → Omarigliptin 25 mg/BG (Phase B) Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
Placebo/TZD (Phase A) → Omarigliptin 25 mg/TZD (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
Placebo/α-GI (Phase A) → Omarigliptin 25 mg/α-GI (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.

Participant Flow for 2 periods

Period 1:   Phase A (Up to 24 Weeks)
    Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)     Omarigliptin 25 mg/Glinides (Gln.) (Phase A+B)     Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)     Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)     Omarigliptin 25 mg/α-GI (Phase A+B)     Placebo/SU (Phase A) → Omarigliptin 25 mg/SU (Phase B)     Placebo/Gln. (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)     Placebo/BG (Phase A) → Omarigliptin 25 mg/BG (Phase B)     Placebo/TZD (Phase A) → Omarigliptin 25 mg/TZD (Phase B)     Placebo/α-GI (Phase A) → Omarigliptin 25 mg/α-GI (Phase B)  
STARTED     126     65     66     65     67     63     34     33     34     32  
COMPLETED     123     62     65     63     67     62     32     33     34     30  
NOT COMPLETED     3     3     1     2     0     1     2     0     0     2  
Lost to Follow-up                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Physician Decision                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 1                 0                 0                 0                 0                 1                 0                 0                 1  
Adverse Event                 0                 2                 1                 2                 0                 0                 1                 0                 0                 1  

Period 2:   Phase B (Week 25 to Week 52)
    Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)     Omarigliptin 25 mg/Glinides (Gln.) (Phase A+B)     Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)     Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)     Omarigliptin 25 mg/α-GI (Phase A+B)     Placebo/SU (Phase A) → Omarigliptin 25 mg/SU (Phase B)     Placebo/Gln. (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)     Placebo/BG (Phase A) → Omarigliptin 25 mg/BG (Phase B)     Placebo/TZD (Phase A) → Omarigliptin 25 mg/TZD (Phase B)     Placebo/α-GI (Phase A) → Omarigliptin 25 mg/α-GI (Phase B)  
STARTED     123     62     65     63     67     62     32     33     34     30  
COMPLETED     118     61     64     60     67     60     31     32     32     30  
NOT COMPLETED     5     1     1     3     0     2     1     1     2     0  
Physician Decision                 1                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 2                 0                 0                 0                 0                 1                 0                 1                 0                 0  
Adverse Event                 2                 1                 1                 2                 0                 1                 1                 0                 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.
No text entered.

Reporting Groups
  Description
Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
Omarigliptin 25 mg/Glinides (Gln.) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln. throughout the duration of the study.
Omarigliptin 25 mg/Biguanides (BG) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
Omarigliptin 25 mg/α-GI (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
Placebo/SU (Phase A) → Omarigliptin 25 mg/SU (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
Placebo/Gln. (Phase A) → Omarigliptin 25 mg/Gln. (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
Placebo/BG (Phase A) → Omarigliptin 25 mg/BG (Phase B) Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
Placebo/TZD (Phase A) → Omarigliptin 25 mg/TZD (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
Placebo/α-GI (Phase A) → Omarigliptin 25 mg/α-GI (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)     Omarigliptin 25 mg/Glinides (Gln.) (Phase A+B)     Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)     Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)     Omarigliptin 25 mg/α-GI (Phase A+B)     Placebo/SU (Phase A) → Omarigliptin 25 mg/SU (Phase B)     Placebo/Gln. (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)     Placebo/BG (Phase A) → Omarigliptin 25 mg/BG (Phase B)     Placebo/TZD (Phase A) → Omarigliptin 25 mg/TZD (Phase B)     Placebo/α-GI (Phase A) → Omarigliptin 25 mg/α-GI (Phase B)     Total  
Number of Participants  
[units: participants]
  126     65     66     65     67     63     34     33     34     32     585  
Age  
[units: Years]
Mean (Standard Deviation)
  63  (9)     59  (11)     59  (9)     61  (10)     61  (11)     63  (11)     61  (10)     57  (9)     61  (9)     61  (11)     61  (10)  
Gender  
[units: Participants]
                     
Female     35     19     20     23     21     18     7     10     7     9     169  
Male     91     46     46     42     46     45     27     23     27     23     416  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A   [ Time Frame: Up to 24 weeks ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study   [ Time Frame: Up to 52 weeks ]

3.  Primary:   Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A   [ Time Frame: Up to 24 weeks ]

4.  Primary:   Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study   [ Time Frame: Up to 52 weeks ]

5.  Secondary:   Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24   [ Time Frame: Baseline and Week 24 ]


  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01697592     History of Changes
Other Study ID Numbers: 3102-015
132242 ( Registry Identifier: JAPIC-CTI )
Study First Received: September 28, 2012
Results First Received: September 29, 2015
Last Updated: September 29, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency