Trial · NCT00837577
MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
NCT00837577, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104). Trials, record NCT00837577. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00837577
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
- NCT number
- NCT00837577
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- Comparator: Placebo, Sitagliptin, Voglibose
- First posted
- 2009-02-05
- Last updated
- 2017-05-15
- Results first posted
- 2011-09-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 | Baseline and Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%). |
| Secondary | Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Baseline and Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Baseline and Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. |
Source ClinicalTrials.gov
Outcomes3
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 (HbA1c) at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | Percentage of glycosylated hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | mg/dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
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 (HbA1c) at Week 12 | Sitagliptin/Sitagliptin | -0.76 | 95% Confidence Interval 0.42 | Percentage of glycosylated hemoglobin | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 | Placebo/Sitagliptin | 0.16 | 95% Confidence Interval 0.64 | Percentage of glycosylated hemoglobin | |
| Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Sitagliptin/Sitagliptin | -55.3 | 95% Confidence Interval 37.9 | mg/dL | |
| Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Placebo/Sitagliptin | -4.0 | 95% Confidence Interval 38.7 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Sitagliptin/Sitagliptin | -22.6 | 95% Confidence Interval 27.1 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Placebo/Sitagliptin | -0.1 | 95% Confidence Interval 22.2 | mg/dL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Sitagliptin/Sitagliptin | 70 | |
| Double-blind Period | STARTED | Placebo/Sitagliptin | 63 | |
| Double-blind Period | COMPLETED | Sitagliptin/Sitagliptin | 68 | |
| Double-blind Period | COMPLETED | Placebo/Sitagliptin | 63 | |
| Double-blind Period | NOT COMPLETED | Sitagliptin/Sitagliptin | 2 | |
| Double-blind Period | NOT COMPLETED | Placebo/Sitagliptin | 0 | |
| Open-label Period | STARTED | Sitagliptin/Sitagliptin | 68 | |
| Open-label Period | STARTED | Placebo/Sitagliptin | 63 | |
| Open-label Period | COMPLETED | Sitagliptin/Sitagliptin | 60 | |
| Open-label Period | COMPLETED | Placebo/Sitagliptin | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Sitagliptin/Sitagliptin (Data Through Week 12) | 5 | 70 | 6 |
| other | Nasopharyngitis | Infections and infestations | Placebo/Sitagliptin (Data Through Week 12) | 4 | 63 | 4 |
| other | Nasopharyngitis | Infections and infestations | Pooled Sitagliptin (Data Through Week 52) | 40 | 133 | 66 |
| other | Blood Triglycerides Increased | Investigations | Sitagliptin/Sitagliptin (Data Through Week 12) | 1 | 70 | 1 |
| other | Blood Triglycerides Increased | Investigations | Placebo/Sitagliptin (Data Through Week 12) | 0 | 63 | 0 |
| other | Blood Triglycerides Increased | Investigations | Pooled Sitagliptin (Data Through Week 52) | 8 | 133 | 9 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Sitagliptin/Sitagliptin (Data Through Week 12) | 1 | 70 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo/Sitagliptin (Data Through Week 12) | 1 | 63 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Pooled Sitagliptin (Data Through Week 52) | 8 | 133 | 10 |
| serious | Cataract | Eye disorders | Sitagliptin/Sitagliptin (Data Through Week 12) | 0 | 70 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin/Sitagliptin (Data Through Week 12) | ||
| Total, all-cause mortality | Placebo/Sitagliptin (Data Through Week 12) | ||
| Total, all-cause mortality | Pooled Sitagliptin (Data Through Week 52) | ||
| Total, other adverse events | Sitagliptin/Sitagliptin (Data Through Week 12) | 7 | 70 |
| Total, other adverse events | Placebo/Sitagliptin (Data Through Week 12) | 5 | 63 |
| Total, other adverse events | Pooled Sitagliptin (Data Through Week 52) | 51 | 133 |
| Total, serious adverse events | Sitagliptin/Sitagliptin (Data Through Week 12) | 0 | 70 |
| Total, serious adverse events | Placebo/Sitagliptin (Data Through Week 12) | 1 | 63 |
| Total, serious adverse events | Pooled Sitagliptin (Data Through Week 52) | 8 | 133 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24843714 | 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/NCT00837577
GET https://conductscience.org/api/trials/v1/NCT00837577/events?page=2