Trial · NCT01704261
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)
NCT01704261, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2015-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT01704261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704261
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT01704261
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Matching placebo to Omarigliptin, Glimepiride, Metformin
- First posted
- 2012-10-11
- Last updated
- 2018-09-10
- Other registries' IDs
- eudract:2012-002612-10
- Results first posted
- 2015-11-25
Source ClinicalTrials.gov
Registered outcomes5
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 | Baseline and Week 24 | A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Up to Week 27 | 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 AE | Up to Week 24 | 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. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). |
| Secondary | Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24 | 24 weeks | The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) or \<7.0% (53 mmol/mol) in the FAS population at Week 24. |
Source ClinicalTrials.gov
Outcomes5
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 | Baseline and Week 24 | 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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis. | %A1C | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Up to Week 27 | 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. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Due to an AE | Up to Week 24 | The ASaT Population was 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. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | 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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24 | 24 weeks | 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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 | Omarigliptin | -0.67 | 95% Confidence Interval -0.84 to -0.50 | %A1C | |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Placebo | -0.06 | 95% Confidence Interval -0.23 to 0.12 | %A1C | |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Omarigliptin | 57.5 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Placebo | 47.7 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Due to an AE | Omarigliptin | 2.6 | Percentage of participants | ||
| Percentage of Participants Who Discontinued From the Study Due to an AE | Placebo | 2.6 | Percentage of participants | ||
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Omarigliptin | -19.6 | 95% Confidence Interval -26.7 to -12.5 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Placebo | -3.0 | 95% Confidence Interval -10.2 to 4.1 | mg/dL | |
| Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24 | Omarigliptin | <7.0% | 23.8 | 95% Confidence Interval 17.5 to 31.5 | Percentage of participants |
| Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24 | Placebo | <7.0% | 4.4 | 95% Confidence Interval 2.1 to 9.3 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omarigliptin | 154 | |
| Overall Study | STARTED | Placebo | 153 | |
| Overall Study | COMPLETED | Omarigliptin | 141 | |
| Overall Study | COMPLETED | Placebo | 138 | |
| Overall Study | NOT COMPLETED | Omarigliptin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events24
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 | Upper respiratory tract infection | Infections and infestations | Omarigliptin | 4 | 153 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 9 | 153 | 11 |
| other | Urinary tract infection | Infections and infestations | Omarigliptin | 9 | 153 | 9 |
| other | Urinary tract infection | Infections and infestations | Placebo | 3 | 153 | 4 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Omarigliptin | 18 | 153 | 65 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 13 | 153 | 44 |
| serious | Vertigo | Ear and labyrinth disorders | Omarigliptin | 1 | 153 | 1 |
| serious | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 153 | 0 |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | Omarigliptin | 0 | 153 | 0 |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | Placebo | 1 | 153 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | ||
| Total, other adverse events | Omarigliptin | 29 | 153 |
| Total, other adverse events | Placebo | 23 | 153 |
| Total, serious adverse events | Omarigliptin | 3 | 153 |
| Total, serious adverse events | Placebo | 5 | 153 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29110647 | 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: 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/NCT01704261
GET https://conductscience.org/api/trials/v1/NCT01704261/events?page=2