Trial · NCT01863667
A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
NCT01863667, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027). Trials, record NCT01863667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01863667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
- NCT number
- NCT01863667
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 65 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Glimepiride, Omarigliptin Placebo, Glimepiride Placebo
- First posted
- 2013-05-29
- Last updated
- 2018-09-10
- Other registries' IDs
- eudract:2013-000301-23
- Results first posted
- 2016-01-21
- Limitations and caveats
- The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.
Source ClinicalTrials.gov
Registered outcomes8
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 54 | Baseline and Week 54 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event | Up to 57 weeks (including 3 weeks following the last dose of study drug) | 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 pre-existing conditions. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 54 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 pre-existing conditions. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 | Baseline and Week 54 | This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0. |
| Secondary | Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment | 54 weeks | Percentage of participants achieving glycemic goal (A1C \<7% or \<6.5%) after 54 weeks of treatment. |
| Secondary | Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment | 54 weeks | Percentage of Participants who had an A1C decrease \>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment |
| Secondary | Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia | Up to 54 weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported. |
| Secondary | Change From Baseline in Body Weight at Week 54 | Baseline and Week 54 | Body weight was to be measured (in duplicate) using a calibrated digital scale. |
Source ClinicalTrials.gov
Outcomes8
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 54 | Baseline and Week 54 | Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54. | ||
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event | Up to 57 weeks (including 3 weeks following the last dose of study drug) | All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 54 weeks | All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 | Baseline and Week 54 | Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54. | ||
| SECONDARY | Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment | 54 weeks | Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54. | ||
| SECONDARY | Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment | 54 weeks | Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54. | ||
| SECONDARY | Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia | Up to 54 weeks | All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. | ||
| SECONDARY | Change From Baseline in Body Weight at Week 54 | Baseline and Week 54 | All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced at Least One Adverse Event | Omarigliptin | 9.1 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event | Glimepiride | 15.6 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Omarigliptin | 3 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Glimepiride | 0 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omarigliptin | 33 | |
| Overall Study | STARTED | Glimepiride | 32 | |
| Overall Study | COMPLETED | Omarigliptin | 0 | |
| Overall Study | COMPLETED | Glimepiride | 0 | |
| Overall Study | NOT COMPLETED | Omarigliptin | 33 | |
| Overall Study | NOT COMPLETED | Glimepiride | 32 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Epilepsy | Nervous system disorders | Omarigliptin | 1 | 33 | 1 |
| serious | Epilepsy | Nervous system disorders | Glimepiride | 0 | 32 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omarigliptin | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | Omarigliptin | 0 | 33 |
| Total, other adverse events | Glimepiride | 0 | 32 |
| Total, serious adverse events | Omarigliptin | 1 | 33 |
| Total, serious adverse events | Glimepiride | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 Glimepiride: 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/NCT01863667
GET https://conductscience.org/api/trials/v1/NCT01863667/registered