Trial · NCT00482729
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
NCT00482729, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED). Trials, record NCT00482729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00482729
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
- NCT number
- NCT00482729
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,246 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- sitagliptin phosphate (+) metformin hydrochloride, metformin
- First posted
- 2007-06-05
- Last updated
- 2017-06-09
- Results first posted
- 2010-03-15
- Limitations and caveats
Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.
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 18 | Baseline and Week 18 | A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. |
| Secondary | Number of Patients With A1C < 7.0% at Week 18 | Week 18 | |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Baseline and Week 18 | FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL. |
| Other | Change From Baseline in A1C at Week 44 | Baseline and Week 44 | A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent. |
| Other | Number of Patients With A1C < 7.0% at Week 44 | Week 44 |
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 18 | Baseline and Week 18 | The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With A1C < 7.0% at Week 18 | Week 18 | The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Baseline and Week 18 | The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | mg/dL | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in A1C at Week 44 | Baseline and Week 44 | The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44. | Percent | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Patients With A1C < 7.0% at Week 44 | Week 44 | The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
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 18 | Sita/Met FDC | -2.37 | 95% Confidence Interval -2.49 to -2.24 | Percent | |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 18 | Metformin | -1.76 | 95% Confidence Interval -1.88 to -1.64 | Percent | |
| Number of Patients With A1C < 7.0% at Week 18 | Sita/Met FDC | Patients with A1C <7.0% at Week 18 | 275 | Participants | |
| Number of Patients With A1C < 7.0% at Week 18 | Metformin | Patients with A1C <7.0% at Week 18 | 193 | Participants | |
| Number of Patients With A1C < 7.0% at Week 18 | Sita/Met FDC | Patients with A1C ≥7.0% at Week 18 | 284 | Participants | |
| Number of Patients With A1C < 7.0% at Week 18 | Metformin | Patients with A1C ≥7.0% at Week 18 | 371 | Participants | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Sita/Met FDC | -69.4 | 95% Confidence Interval -74.1 to -64.6 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Metformin | -53.7 | 95% Confidence Interval -58.4 to -48.9 | mg/dL | |
| Change From Baseline in A1C at Week 44 | Sita/Met FDC | -2.25 | 95% Confidence Interval -2.38 to -2.12 | Percent | |
| Change From Baseline in A1C at Week 44 | Metformin | -1.77 | 95% Confidence Interval -1.89 to -1.64 | Percent |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sita/Met FDC | 626 | |
| Overall Study | STARTED | Metformin | 624 | |
| Overall Study | Completed Phase A | Sita/Met FDC | 484 | |
| Overall Study | Completed Phase A | Metformin | 482 | |
| Overall Study | Completed Phase B | Sita/Met FDC | 409 | |
| Overall Study | Completed Phase B | Metformin | 406 | |
| Overall Study | COMPLETED | Sita/Met FDC | 409 | |
| Overall Study | COMPLETED | Metformin | 406 | |
| Overall Study | NOT COMPLETED | Sita/Met FDC | 217 | |
| Overall Study | NOT COMPLETED | Metformin | 218 |
Source ClinicalTrials.gov
Adverse events172
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 | Any Gastrointestinal Disorders | Gastrointestinal disorders | Sita/Met FDC | 107 | 625 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Metformin | 136 | 621 | |
| other | Diarrhoea | Gastrointestinal disorders | Sita/Met FDC | 86 | 625 | |
| other | Diarrhoea | Gastrointestinal disorders | Metformin | 112 | 621 | |
| other | Nausea | Gastrointestinal disorders | Sita/Met FDC | 37 | 625 | |
| other | Nausea | Gastrointestinal disorders | Metformin | 44 | 621 | |
| other | Any Infections and infestations | Infections and infestations | Sita/Met FDC | 62 | 625 | |
| other | Any Infections and infestations | Infections and infestations | Metformin | 57 | 621 | |
| other | Nasopharyngitis | Infections and infestations | Sita/Met FDC | 33 | 625 | |
| other | Nasopharyngitis | Infections and infestations | Metformin | 26 | 621 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sita/Met FDC | ||
| Total, all-cause mortality | Metformin | ||
| Total, other adverse events | Sita/Met FDC | 173 | 625 |
| Total, other adverse events | Metformin | 185 | 621 |
| Total, serious adverse events | Sita/Met FDC | 28 | 625 |
| Total, serious adverse events | Metformin | 38 | 621 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Sita/Met FDC vs Metformin: 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/NCT00482729
GET https://conductscience.org/api/trials/v1/NCT00482729/events?page=2