Trial · NCT01405911
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
NCT01405911, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2019-12-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105). Trials, record NCT01405911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01405911
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
- NCT number
- NCT01405911
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 242 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Glucose Intolerance
- Interventions
- Placebo for Sitagliptin 25 mg, Placebo for Sitagliptin 50 mg, Sitagliptin 25 mg, Sitagliptin 50 mg
- First posted
- 2011-07-29
- Last updated
- 2020-01-18
- Results first posted
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 | Baseline (Week 0) and Week 8 | Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal. |
| Primary | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Up to 10 weeks | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Primary | Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | Up to 8 weeks | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Secondary | Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7 | Baseline (Week -1) and Week 7 | Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 | Baseline (Week 0) and Week 8 | All participants, as randomized, who received at least one dose of study treatment and have a baseline measurement or post-randomization measurement for the analysis endpoint subsequent to study treatment. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7 | Baseline (Week -1) and Week 7 | All participants, as randomized, who received at least one dose of study treatment and have a baseline measurement or post-randomization measurement for the analysis endpoint subsequent to study treatment. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Up to 10 weeks | All randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the actual study treatment they received. Due to a prescription error, one participant who was randomized to the placebo group took sitagliptin 50 mg. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | Up to 8 weeks | All randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the actual study treatment they received. Due to a prescription error, one participant who was randomized to the placebo group took sitagliptin 50 mg. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 | Placebo | -2.42 | 95% Confidence Interval -4.48 to -0.31 | Percent change | |
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 | Sitagliptin 25 mg | -9.52 | 95% Confidence Interval -11.43 to -7.57 | Percent change | |
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 | Sitagliptin 50 mg | -11.49 | 95% Confidence Interval -13.40 to -9.55 | Percent change | |
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7 | Placebo | -3.68 | 95% Confidence Interval -6.66 to -0.60 | Percent change | |
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7 | Sitagliptin 25 mg | -21.38 | 95% Confidence Interval -23.81 to -18.87 | Percent change | |
| Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7 | Sitagliptin 50 mg | -20.09 | 95% Confidence Interval -22.61 to -17.48 | Percent change | |
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Placebo | 30.9 | Percentage of participants | ||
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Sitagliptin 25 mg | 34.1 | Percentage of participants | ||
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | Sitagliptin 50 mg | 41.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | Placebo | 0.0 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 83 | |
| Overall Study | STARTED | Sitagliptin 25 mg | 82 | |
| Overall Study | STARTED | Sitagliptin 50 mg | 77 | |
| Overall Study | Treated | Placebo | 82 | |
| Overall Study | Treated | Sitagliptin 25 mg | 82 | |
| Overall Study | Treated | Sitagliptin 50 mg | 77 | |
| Overall Study | COMPLETED | Placebo | 79 | |
| Overall Study | COMPLETED | Sitagliptin 25 mg | 79 | |
| Overall Study | COMPLETED | Sitagliptin 50 mg | 76 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
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 | Placebo | 7 | 81 | 7 |
| other | Nasopharyngitis | Infections and infestations | Sitagliptin 25 mg | 9 | 82 | 9 |
| other | Nasopharyngitis | Infections and infestations | Sitagliptin 50 mg | 7 | 78 | 7 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 7 | 81 | 7 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin 25 mg | 5 | 82 | 9 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sitagliptin 50 mg | 4 | 78 | 5 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 81 |
| Total, all-cause mortality | Sitagliptin 25 mg | 0 | 82 |
| Total, all-cause mortality | Sitagliptin 50 mg | 0 | 78 |
| Total, other adverse events | Placebo | 13 | 81 |
| Total, other adverse events | Sitagliptin 25 mg | 14 | 82 |
| Total, other adverse events | Sitagliptin 50 mg | 11 | 78 |
| Total, serious adverse events | Placebo | 0 | 81 |
| Total, serious adverse events | Sitagliptin 25 mg | 0 | 82 |
| Total, serious adverse events | Sitagliptin 50 mg | 0 | 78 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26094974 | BACKGROUND |
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/NCT01405911
GET https://conductscience.org/api/trials/v1/NCT01405911/registered