Trial · NCT00103857
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
NCT00103857, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036). Trials, record NCT00103857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
- NCT number
- NCT00103857
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,208 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Comparator: MK0431 100 mg q.d. (q.d. = once daily), Comparator: Placebo (Phase A)/Metformin (Phase B), Comparator: Metformin 500 mg b.i.d., Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d., Comparator: Metformin 1000 mg b.i.d.
- First posted
- 2005-02-16
- Last updated
- 2017-05-05
- Results first posted
- 2009-05-19
- Limitations and caveats
- Non-serious adverse experience results represent those events included in the primary safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Week 24 | HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. |
| Secondary | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 | Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. |
| Secondary | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 | Week 54 | HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 | Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0. |
| Secondary | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 | Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0. |
| Secondary | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 | Week 104 | HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. |
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104 | Week 104 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. |
| Secondary | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104 | Week 104 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. |
Source ClinicalTrials.gov
Outcomes9
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 HbA1c (Hemoglobin A1C) at Week 24 | Week 24 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Week 24 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 | Week 24 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 | Week 54 | The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 | Week 54 | The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 | Week 54 | The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 | Week 104 | The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104 | Week 104 | The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104 | Week 104 | The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward. | mg/dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group54
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 HbA1c (Hemoglobin A1C) at Week 24 | Sitagliptin 100 mg q.d. | -0.66 | 95% Confidence Interval -0.83 to -0.50 | Percent | |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Metformin 500 mg b.i.d. | -0.82 | 95% Confidence Interval -0.98 to -0.66 | Percent | |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Metformin 1000 mg b.i.d. | -1.13 | 95% Confidence Interval -1.29 to -0.97 | Percent | |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. | -1.40 | 95% Confidence Interval -1.56 to -1.24 | Percent | |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. | -1.90 | 95% Confidence Interval -2.06 to -1.74 | Percent | |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | Placebo/Metformin 1000 mg b.i.d. | 0.17 | 95% Confidence Interval 0.00 to 0.33 | Percent | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Sitagliptin 100 mg q.d. | -17.5 | 95% Confidence Interval -24.1 to -10.8 | mg/dL | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Metformin 500 mg b.i.d. | -27.3 | 95% Confidence Interval -34.0 to -20.7 | mg/dL | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Metformin 1000 mg b.i.d. | -29.3 | 95% Confidence Interval -35.9 to -22.6 | mg/dL | |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. | -47.1 | 95% Confidence Interval -53.7 to -40.6 | mg/dL |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 54-Week Base Study | STARTED | Sitagliptin 100 mg q.d. | 179 | |
| 54-Week Base Study | STARTED | Metformin 500 mg b.i.d. | 182 | |
| 54-Week Base Study | STARTED | Metformin 1000 mg b.i.d. | 182 | |
| 54-Week Base Study | STARTED | Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. | 190 | |
| 54-Week Base Study | STARTED | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. | 182 | |
| 54-Week Base Study | STARTED | Placebo/Metformin 1000 mg b.i.d. | 176 | |
| 54-Week Base Study | STARTED | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC | 117 | |
| 54-Week Base Study | COMPLETED | Sitagliptin 100 mg q.d. | 122 | |
| 54-Week Base Study | COMPLETED | Metformin 500 mg b.i.d. | 126 | |
| 54-Week Base Study | COMPLETED | Metformin 1000 mg b.i.d. | 135 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events833
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 | Sitagliptin 100 mg q.d. | 19 | 179 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Metformin 500 mg b.i.d. | 23 | 182 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Metformin 1000 mg b.i.d. | 42 | 182 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. | 31 | 190 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. | 35 | 182 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Placebo/Metformin 1000 mg b.i.d. | 17 | 176 | |
| other | Any Gastrointestinal Disorders | Gastrointestinal disorders | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC | 18 | 117 | |
| other | Constipation | Gastrointestinal disorders | Sitagliptin 100 mg q.d. | 9 | 179 | |
| other | Constipation | Gastrointestinal disorders | Metformin 500 mg b.i.d. | 6 | 182 | |
| other | Constipation | Gastrointestinal disorders | Metformin 1000 mg b.i.d. | 6 | 182 |
1 to 10 of 833Source ClinicalTrials.gov
See all 833 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin 100 mg q.d. | ||
| Total, all-cause mortality | Metformin 500 mg b.i.d. | ||
| Total, all-cause mortality | Metformin 1000 mg b.i.d. | ||
| Total, all-cause mortality | Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. | ||
| Total, all-cause mortality | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. | ||
| Total, all-cause mortality | Placebo/Metformin 1000 mg b.i.d. | ||
| Total, all-cause mortality | Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC | ||
| Total, other adverse events | Sitagliptin 100 mg q.d. | 71 | |
| Total, other adverse events | Metformin 500 mg b.i.d. | 74 | |
| Total, other adverse events | Metformin 1000 mg b.i.d. | 99 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
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 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/NCT00103857
GET https://conductscience.org/api/trials/v1/NCT00103857/results?page=2