Trial · NCT00974090
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
NCT00974090, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes. Trials, record NCT00974090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00974090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
- NCT number
- NCT00974090
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 194 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea), Teneli / Teneli + SU
- First posted
- 2009-09-10
- Last updated
- 2026-01-05
- Results first posted
- 2014-05-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c at Week 12 | at Week 0 and Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | at Week 0 and Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. |
| Secondary | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. |
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | at Week 0 and Week 12 | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. |
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 | Change From Baseline in HbA1c at Week 12 | at Week 0 and Week 12 | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 12 | at Week 0 and Week 12 | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | mg / dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. | mg・hr/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | at Week 0 and Week 12 | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. | mg / dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
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 at Week 12 | Placebo / Teneli + SU | 0.29 | Standard Error 0.06 | percentage of HbA1c | |
| Change From Baseline in HbA1c at Week 12 | Teneli / Teneli + SU | -0.71 | Standard Error 0.06 | percentage of HbA1c | |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Placebo / Teneli + SU | 9.8 | Standard Error 2.2 | mg / dL | |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Teneli / Teneli + SU | -17.3 | Standard Error 2.2 | mg / dL | |
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | Placebo / Teneli + SU | 15.514 | Standard Error 6.072 | mg・hr/dL | |
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | Teneli / Teneli + SU | -65.544 | Standard Error 6.072 | mg・hr/dL | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | Placebo / Teneli + SU | 6.0 | Standard Error 4.4 | mg / dL | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | Teneli / Teneli + SU | -43.1 | Standard Error 4.4 | mg / dL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Double Blind Period | STARTED | Placebo / Teneli + SU | 98 | |
| Period 1: Double Blind Period | STARTED | Teneli / Teneli + SU | 96 | |
| Period 1: Double Blind Period | COMPLETED | Placebo / Teneli + SU | 95 | |
| Period 1: Double Blind Period | COMPLETED | Teneli / Teneli + SU | 95 | |
| Period 1: Double Blind Period | NOT COMPLETED | Placebo / Teneli + SU | 3 | |
| Period 1: Double Blind Period | NOT COMPLETED | Teneli / Teneli + SU | 1 | |
| Period 2: Open-label Period | STARTED | Placebo / Teneli + SU | 95 | |
| Period 2: Open-label Period | STARTED | Teneli / Teneli + SU | 95 | |
| Period 2: Open-label Period | COMPLETED | Placebo / Teneli + SU | 87 | |
| Period 2: Open-label Period | COMPLETED | Teneli / Teneli + SU | 85 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events868
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 | Body tinea | Infections and infestations | Placebo/Teneli + SU (Data Through Week 12) | 0 | 98 | |
| other | Body tinea | Infections and infestations | Teneli/Teneli + SU (Data Through Week 12) | 0 | 96 | |
| other | Body tinea | Infections and infestations | Placebo/Teneli + SU (Data From Week 12 to Week 52) | 2 | 95 | |
| other | Body tinea | Infections and infestations | Teneli/Teneli + SU (Data Through Week 52) | 0 | 96 | |
| other | Bronchitis | Infections and infestations | Placebo/Teneli + SU (Data Through Week 12) | 0 | 98 | |
| other | Bronchitis | Infections and infestations | Teneli/Teneli + SU (Data Through Week 12) | 2 | 96 | |
| other | Bronchitis | Infections and infestations | Placebo/Teneli + SU (Data From Week 12 to Week 52) | 3 | 95 | |
| other | Bronchitis | Infections and infestations | Teneli/Teneli + SU (Data Through Week 52) | 8 | 96 | |
| other | Bronchopneumonia | Infections and infestations | Placebo/Teneli + SU (Data Through Week 12) | 0 | 98 | |
| other | Bronchopneumonia | Infections and infestations | Teneli/Teneli + SU (Data Through Week 12) | 0 | 96 |
1 to 10 of 868Source ClinicalTrials.gov
See all 868 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Teneli + SU (Data Through Week 12) | ||
| Total, all-cause mortality | Teneli/Teneli + SU (Data Through Week 12) | ||
| Total, all-cause mortality | Placebo/Teneli + SU (Data From Week 12 to Week 52) | ||
| Total, all-cause mortality | Teneli/Teneli + SU (Data Through Week 52) | ||
| Total, other adverse events | Placebo/Teneli + SU (Data Through Week 12) | 60 | 98 |
| Total, other adverse events | Teneli/Teneli + SU (Data Through Week 12) | 62 | 96 |
| Total, other adverse events | Placebo/Teneli + SU (Data From Week 12 to Week 52) | 89 | 95 |
| Total, other adverse events | Teneli/Teneli + SU (Data Through Week 52) | 89 | 96 |
| Total, serious adverse events | Placebo/Teneli + SU (Data Through Week 12) | 2 | 98 |
| Total, serious adverse events | Teneli/Teneli + SU (Data Through Week 12) | 0 | 96 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24205974 | 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/NCT00974090
GET https://conductscience.org/api/trials/v1/NCT00974090/events?page=2