Trial · NCT01717313
A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
NCT01717313, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011). Trials, record NCT01717313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01717313
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
- NCT number
- NCT01717313
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 329 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Placebo to Omarigliptin, Metformin, Placebo to metformin, Glimepiride
- First posted
- 2012-10-30
- Last updated
- 2018-09-10
- Other registries' IDs
- eudract:2012-003626-24
- Results first posted
- 2016-07-25
- Limitations and caveats
Care must be taken in the interpretation of the results in this study as the non-protocol-specified prohibited use of metformin among a number of participants may have impacted the safety and efficacy results disproportionally among study arms.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | A1C (%) is used to report average blood glucose levels over prolonged periods of time. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis). |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 27 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin). |
| Primary | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 24 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin). |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin). |
| Primary | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin). |
| Secondary | Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS population at Week 24. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis). |
| Secondary | Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS population at Week 24. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis). |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis). |
| Secondary | Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis). |
| Secondary | Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population) | Baseline and Week 54 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C. The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 27 weeks | The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 24 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population) | Baseline and Week 54 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | Percent | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) | Omarigliptin | -0.49 | 95% Confidence Interval -0.73 to -0.24 | Percent | |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) | Placebo to Omarigliptin | -0.10 | 95% Confidence Interval -0.34 to 0.14 | Percent | |
| Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Omarigliptin | 41.8 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Placebo to Omarigliptin | 50.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Omarigliptin | 2.4 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Placebo to Omarigliptin | 1.8 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Omarigliptin | 54.5 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Placebo to Omarigliptin | 60.4 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Omarigliptin | 3.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Placebo to Omarigliptin | 2.4 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A (Weeks 0 to 24) | STARTED | Omarigliptin | 165 | |
| Phase A (Weeks 0 to 24) | STARTED | Placebo to Omarigliptin | 164 | |
| Phase A (Weeks 0 to 24) | COMPLETED | Omarigliptin | 147 | |
| Phase A (Weeks 0 to 24) | COMPLETED | Placebo to Omarigliptin | 151 | |
| Phase A (Weeks 0 to 24) | NOT COMPLETED | Omarigliptin | 18 | |
| Phase A (Weeks 0 to 24) | NOT COMPLETED | Placebo to Omarigliptin | 13 | |
| Interphase | STARTED | Omarigliptin | 147 | |
| Interphase | STARTED | Placebo to Omarigliptin | 151 | |
| Interphase | COMPLETED | Omarigliptin | 146 | |
| Interphase | COMPLETED | Placebo to Omarigliptin | 151 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Omarigliptin | 17 | 165 | 21 |
| other | Nasopharyngitis | Infections and infestations | Placebo to Omarigliptin | 12 | 164 | 16 |
| other | Blood glucose increased | Investigations | Omarigliptin | 14 | 165 | 14 |
| other | Blood glucose increased | Investigations | Placebo to Omarigliptin | 13 | 164 | 13 |
| serious | Acute myocardial infarction | Cardiac disorders | Omarigliptin | 0 | 165 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo to Omarigliptin | 1 | 164 | 1 |
| serious | Cataract | Eye disorders | Omarigliptin | 0 | 165 | 0 |
| serious | Cataract | Eye disorders | Placebo to Omarigliptin | 1 | 164 | 1 |
| serious | Pneumonia | Infections and infestations | Omarigliptin | 1 | 165 | 1 |
| serious | Pneumonia | Infections and infestations | Placebo to Omarigliptin | 0 | 164 | 0 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omarigliptin | ||
| Total, all-cause mortality | Placebo to Omarigliptin | ||
| Total, other adverse events | Omarigliptin | 31 | 165 |
| Total, other adverse events | Placebo to Omarigliptin | 25 | 164 |
| Total, serious adverse events | Omarigliptin | 8 | 165 |
| Total, serious adverse events | Placebo to Omarigliptin | 8 | 164 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29079379 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omarigliptin vs Placebo to Omarigliptin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01717313
GET https://conductscience.org/api/trials/v1/NCT01717313/results?page=2