Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01704261 |
|
Recruitment Status :
Completed
First Posted : October 11, 2012
Results First Posted : November 25, 2015
Last Update Posted : September 10, 2018
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| 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: Metformin |
| Enrollment | 307 |
Participant Flow
| Recruitment Details | Fifty-one sites received IEC/IRB approval and were shipped clinical supplies. |
| Pre-assignment Details | In total, 583 participants were screened and 276 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values. |
| Arm/Group Title | Omarigliptin | Placebo |
|---|---|---|
 Arm/Group Description |
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). | Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). |
| Period Title: Overall Study | ||
| Started | 154 | 153 |
| Completed | 141 | 138 |
| Not Completed | 13 | 15 |
| Reason Not Completed | ||
| Withdrawal by Subject | 12 | 15 |
| Lost to Follow-up | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Omarigliptin | Placebo | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). | Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 154 | 153 | 307 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 154 participants | 153 participants | 307 participants | |
| 57.2 (8.4) | 58.4 (9.4) | 57.8 (8.9) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 154 participants | 153 participants | 307 participants | |
| Female |
81 52.6%
|
79 51.6%
|
160 52.1%
|
|
| Male |
73 47.4%
|
74 48.4%
|
147 47.9%
|
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
| Name/Title: | Senior Vice President, Global Clinical Development |
| Organization: | Merck Sharp & Dohme Corp. |
| Phone: | 1-800-672-6372 |
| EMail: | ClinicalTrialsDisclosure@merck.com |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01704261 |
| Other Study ID Numbers: |
3102-022 2012-002612-10 ( EudraCT Number ) |
| First Submitted: | October 8, 2012 |
| First Posted: | October 11, 2012 |
| Results First Submitted: | October 23, 2015 |
| Results First Posted: | November 25, 2015 |
| Last Update Posted: | September 10, 2018 |