Trial · NCT00929201
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
NCT00929201, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2010-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080). Trials, record NCT00929201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00929201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
- NCT number
- NCT00929201
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 61 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin phosphate/metformin hydrochloride FDC, Sitagliptin phosphate, Metformin hydrochloride
- First posted
- 2009-06-26
- Last updated
- 2015-08-13
- Results first posted
- 2010-02-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | Serum samples were used to determine the AUC from time 0 to infinity for metformin. |
| Secondary | Peak Plasma Concentration (Cmax) of Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | Serum samples were used to determine the maximum concentration for metformin. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | All participants who completed and who had pharmacokinetic data available from at least one treatment period | μg * hr/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Peak Plasma Concentration (Cmax) of Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | All participants who completed and who had pharmacokinetic data available from at least one treatment period | ng/mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Sita + Met | 7.65 | Standard Deviation 1.39 | μg * hr/mL | |
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Sita/Met FDC | 7.45 | Standard Deviation 1.48 | μg * hr/mL | |
| Peak Plasma Concentration (Cmax) of Metformin | Sita + Met | 929 | Standard Deviation 181 | ng/mL | |
| Peak Plasma Concentration (Cmax) of Metformin | Sita/Met FDC | 887 | Standard Deviation 187 | ng/mL |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Sita + Met Then Sita/Met FDC | 30 | |
| Period 1 | STARTED | Sita/Met FDC Then Sita + Met | 31 | |
| Period 1 | COMPLETED | Sita + Met Then Sita/Met FDC | 30 | |
| Period 1 | COMPLETED | Sita/Met FDC Then Sita + Met | 30 | |
| Period 1 | NOT COMPLETED | Sita + Met Then Sita/Met FDC | 0 | |
| Period 1 | NOT COMPLETED | Sita/Met FDC Then Sita + Met | 1 | |
| 7-day Washout | STARTED | Sita + Met Then Sita/Met FDC | 30 | |
| 7-day Washout | STARTED | Sita/Met FDC Then Sita + Met | 30 | |
| 7-day Washout | COMPLETED | Sita + Met Then Sita/Met FDC | 30 | |
| 7-day Washout | COMPLETED | Sita/Met FDC Then Sita + Met | 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2
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 | Headache | Nervous system disorders | Sita + Met | 2 | 60 | |
| other | Headache | Nervous system disorders | Sita/Met FDC | 6 | 61 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sita + Met | ||
| Total, all-cause mortality | Sita/Met FDC | ||
| Total, other adverse events | Sita + Met | 2 | 60 |
| Total, other adverse events | Sita/Met FDC | 6 | 61 |
| Total, serious adverse events | Sita + Met | 0 | 60 |
| Total, serious adverse events | Sita/Met FDC | 0 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 vs Sita/Met FDC: 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/NCT00929201
GET https://conductscience.org/api/trials/v1/NCT00929201/registered