Trial · NCT01698775
A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)
NCT01698775, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019). Trials, record NCT01698775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01698775
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)
- NCT number
- NCT01698775
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 213 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Placebo to omarigliptin, Glipizide, Placebo to glipizide, Insulin
- First posted
- 2012-10-03
- Last updated
- 2018-08-09
- Other registries' IDs
- eudract:2012-002332-85
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 | Baseline and Week 24 | A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) | Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) | Up to 24 weeks | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Up to 58 weeks (including 28 days following the last dose of study therapy) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Up to 54 weeks | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. |
| Secondary | Change From Baseline in A1C at Week 54 | Baseline and Week 54 | A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. |
| Secondary | Change From Baseline in FPG at Week 54 | Baseline and Week 54 | Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 | Baseline and Week 24 | Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis. |
| Secondary | Change From Baseline in eGFR at Week 54 | Baseline and Week 54 | Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis. |
Source ClinicalTrials.gov
Outcomes10
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 Glycosylated Hemoglobin (A1C) at Week 24 | Baseline and Week 24 | Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication. | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) | Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug) | All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) | Up to 24 weeks | APaT population consists of all randomized participants who took at least 1 dose of trial treatment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Up to 58 weeks (including 28 days following the last dose of study therapy) | APaT population consists of all randomized participants who took at least 1 dose of trial treatment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Up to 54 weeks | APaT population consists of all randomized participants who took at least 1 dose of trial treatment. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in A1C at Week 54 | Baseline and Week 54 | FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG at Week 54 | Baseline and Week 54 | FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 | Baseline and Week 24 | APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B). | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in eGFR at Week 54 | Baseline and Week 54 | APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
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 Glycosylated Hemoglobin (A1C) at Week 24 | Omarigliptin (Phase A) | -0.77 | 95% Confidence Interval -1.00 to -0.54 | Percent | |
| Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 | Placebo to Omarigliptin (Phase A) | -0.44 | 95% Confidence Interval -0.67 to -0.21 | Percent | |
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) | Omarigliptin (Phase A) | 66.0 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period) | Placebo to Omarigliptin (Phase A) | 69.8 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) | Omarigliptin (Phase A) | 2.8 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period) | Placebo to Omarigliptin (Phase A) | 0.9 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 77.4 | Percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 78.3 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 6.6 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period) | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 3.8 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A | STARTED | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 107 | |
| Phase A | STARTED | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 106 | |
| Phase A | COMPLETED | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 98 | |
| Phase A | COMPLETED | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 97 | |
| Phase A | NOT COMPLETED | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 9 | |
| Phase A | NOT COMPLETED | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 9 | |
| Phase B | STARTED | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 98 | |
| Phase B | STARTED | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 97 | |
| Phase B | COMPLETED | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 84 | |
| Phase B | COMPLETED | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 86 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
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 (Phase A) | 4 | 106 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo to Omarigliptin (Phase A) | 8 | 106 | 9 |
| other | Upper respiratory tract infection | Infections and infestations | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 4 | 106 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 12 | 106 | 14 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Omarigliptin (Phase A) | 21 | 106 | 84 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo to Omarigliptin (Phase A) | 19 | 106 | 88 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 27 | 106 | 138 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 25 | 106 | 161 |
| other | Oedema peripheral | General disorders | Omarigliptin (Phase A) | 0 | 106 | 0 |
| other | Oedema peripheral | General disorders | Placebo to Omarigliptin (Phase A) | 2 | 106 | 2 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omarigliptin (Phase A) | ||
| Total, all-cause mortality | Placebo to Omarigliptin (Phase A) | ||
| Total, all-cause mortality | Omarigliptin (Phase A) → Omarigliptin (Phase B) | ||
| Total, all-cause mortality | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | ||
| Total, other adverse events | Omarigliptin (Phase A) | 24 | 106 |
| Total, other adverse events | Placebo to Omarigliptin (Phase A) | 25 | 106 |
| Total, other adverse events | Omarigliptin (Phase A) → Omarigliptin (Phase B) | 44 | 106 |
| Total, other adverse events | Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) | 52 | 106 |
| Total, serious adverse events | Omarigliptin (Phase A) | 10 | 106 |
| Total, serious adverse events | Placebo to Omarigliptin (Phase A) | 13 | 106 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28449320 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01698775
GET https://conductscience.org/api/trials/v1/NCT01698775/events?page=2