Trial · NCT01682759
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
NCT01682759, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016). Trials, record NCT01682759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01682759
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
- NCT number
- NCT01682759
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 751 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Placebo to Omarigliptin, Glimepiride, Glimepiride Placebo, Metformin, Insulin Glargine
- First posted
- 2012-09-11
- Last updated
- 2018-09-07
- Results first posted
- 2016-02-05
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 at Week 54 | Baseline and Week 54 | Hemoglobin A1C is 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. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | Up to Week 57 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. |
| Primary | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | Up to Week 54 | |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 54 | Baseline and Week 54 | Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). |
| Secondary | Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 | Week 54 | The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS Population at Week 54. |
| Secondary | Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue | Up to Week 54 | Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required). |
| Secondary | Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue | Baseline and Week 54 | |
| Secondary | Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 | Week 54 | The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS Population at Week 54. |
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 at Week 54 | Baseline and Week 54 | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | A1C (%) | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | Up to Week 57 | All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | Up to Week 54 | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 54 | Baseline and Week 54 | The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 | Week 54 | The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue | Up to Week 54 | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue | Baseline and Week 54 | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 | Week 54 | The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
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 at Week 54 | Omarigliptin | -0.30 | 95% Confidence Interval -0.39 to -0.21 | A1C (%) | |
| Change From Baseline in Hemoglobin A1C at Week 54 | Glimepiride | -0.48 | 95% Confidence Interval -0.57 to -0.39 | A1C (%) | |
| Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | Omarigliptin | 54.7 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | Glimepiride | 61.6 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | Omarigliptin | 3.7 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | Glimepiride | 2.7 | Percentage of participants | ||
| Change From Baseline in Fasting Plasma Glucose at Week 54 | Omarigliptin | -2.7 | 95% Confidence Interval -6.7 to 1.3 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose at Week 54 | Glimepiride | -8.3 | 95% Confidence Interval -12.4 to -4.3 | mg/dL | |
| Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 | Omarigliptin | 25.1 | 95% Confidence Interval 20.6 to 30.2 | Percentage of participants | |
| Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 | Glimepiride | 28.8 | 95% Confidence Interval 24.1 to 34.0 | Percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omarigliptin | 376 | |
| Overall Study | STARTED | Glimepiride | 375 | |
| Overall Study | Treated | Omarigliptin | 375 | |
| Overall Study | Treated | Glimepiride | 375 | |
| Overall Study | COMPLETED | Omarigliptin | 307 | |
| Overall Study | COMPLETED | Glimepiride | 305 | |
| Overall Study | NOT COMPLETED | Omarigliptin | 69 | |
| Overall Study | NOT COMPLETED | Glimepiride | 70 |
Source ClinicalTrials.gov
Adverse events102
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 | 24 | 375 | 31 |
| other | Nasopharyngitis | Infections and infestations | Glimepiride | 23 | 375 | 30 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Omarigliptin | 21 | 375 | 45 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Glimepiride | 110 | 375 | 487 |
| serious | Acute coronary syndrome | Cardiac disorders | Omarigliptin | 1 | 375 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | Glimepiride | 0 | 375 | 0 |
| serious | Angina pectoris | Cardiac disorders | Omarigliptin | 1 | 375 | 1 |
| serious | Angina pectoris | Cardiac disorders | Glimepiride | 0 | 375 | 0 |
| serious | Cardiac arrest | Cardiac disorders | Omarigliptin | 1 | 375 | 1 |
| serious | Cardiac arrest | Cardiac disorders | Glimepiride | 0 | 375 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 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 | Glimepiride | ||
| Total, other adverse events | Omarigliptin | 43 | 375 |
| Total, other adverse events | Glimepiride | 125 | 375 |
| Total, serious adverse events | Omarigliptin | 24 | 375 |
| Total, serious adverse events | Glimepiride | 18 | 375 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28548024 | 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 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/NCT01682759
GET https://conductscience.org/api/trials/v1/NCT01682759/events?page=2